Cosmetic contact lenses with reversible effects

Abstract

The reversible eye enhancement contact lens comprises a body having a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a peripheral thickness, and a central thickness, wherein one or more of the diameter, base curve, peripheral thickness, or central thickness are configured such that a dSag is less than 1.3% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye, the body further comprising a first region corresponding to a sclera region of the eye, a second region corresponding to a limbal region of the eye, and a third region corresponding to an iris region of the eye, wherein a colorant is incorporated into the first region, the second region, the third region, or a combination thereof, and configured to form a cosmetic design in the first orientation that is different from the cosmetic design in the second orientation. The cosmetic designs in the first and second orientations may differ in colorant, color, limbal design graphic, inner effect design graphic, outer effect design graphic, barrier layer, clear coat base layer, or combinations thereof. Colorants may include metal oxide pigments, coated metal oxide pigments, organic dyes, interference pigments, and combinations thereof.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This patent application claims priority to U.S. Patent Application No. 17 / 031,105, filed September 24, 2021.

[0002] FIELD OF THE INVENTION The present invention relates to ophthalmic lenses, and more particularly to cosmetic contact lenses that are reversible, thereby providing different enhancements to the eye's appearance depending on whether they are worn in a non-inverted or inverted orientation. Such reversible cosmetic contact lenses are created by incorporating multiple effect layers with different patterns, overlapping degrees, and opacity levels from a variety of dyes, pigments, and shades into a contact lens mechanically designed for comfort in both the non-inverted and inverted orientations. Comfortable reversible cosmetic contact lenses can be produced by minimizing the differences in diameter, base curve, central thickness, and / or peripheral thickness between non-inverted and inverted contact lenses. Reversible cosmetic contact lenses also include at least one annular clear layer to encapsulate the multiple effect layers and provide high-quality optics in the optical zone of the lens. While any colorant can be used, reversible cosmetic contact lenses may also incorporate pearlescent pigments in one or more regions to create a lustrous, sparkling, or iridescent appearance in either the non-inverted or inverted orientation, or both. [Background technology]

[0003] A contact lens, or contact, is simply a lens that is placed on the eye. Contact lenses are considered medical devices and may be worn for vision correction and / or for cosmetic or other therapeutic reasons. Contact lenses have been commercially available to improve vision since the 1950s. Early contact lenses were made or fabricated from hard materials and were relatively expensive and fragile. Additionally, the materials from which these early contact lenses were fabricated did not allow sufficient oxygen to permeate through the contact lens to the conjunctiva and cornea, potentially causing numerous clinical side effects. While these contact lenses are still used, they are not suitable for all patients due to their initial poor comfort. Subsequent developments in this field have led to hydrogel-based soft contact lenses, which are very common and widely used today. Silicone hydrogel contact lenses available today combine the benefits of silicone, which has very high oxygen permeability, with the proven comfort and clinical performance of hydrogels. Essentially, these silicone hydrogel-based contact lenses have higher oxygen permeability values ​​and are generally more comfortable to wear than contact lenses made from earlier hard materials, whereas rigid gas-permeable hard contact lenses, made from siloxane-containing polymers, are harder than soft contact lenses and therefore retain their shape better and are more durable.

[0004] Currently available contact lenses remain a cost-effective means of vision correction. Thin plastic lenses are worn over the cornea of ​​the eye to correct vision defects, including myopia (nearsightedness), hyperopia (farsightedness), astigmatism (corneal asphericity), and presbyopia (loss of the lens's ability to accommodate). Contact lenses are available in a variety of forms and are manufactured from a variety of materials to provide different functionality. Daily-wear soft contact lenses are typically manufactured from soft polymeric materials combined with water to provide oxygen permeability. Daily-wear soft contact lenses can be daily disposable or extended-wear disposable. Daily disposable contact lenses are typically worn for one day and then discarded, while extended-wear disposable contact lenses are typically worn for periods of up to 30 days. Tinted soft contact lenses use a variety of materials to provide different functionality. For example, discrimination tinted contact lenses use a bright tint to assist the wearer in finding lost contact lenses, contrast tinted contact lenses have a clear or translucent tint intended to enhance the wearer's natural eye color, tinted color contact lenses include opaque tints intended to alter the wearer's eye color, and light filtering tinted contact lenses function to enhance certain colors while attenuating others. Bifocal and multifocal contact lenses are designed specifically for patients with presbyopia and are available in both soft and hard varieties. Toric contact lenses are designed specifically for patients with astigmatism and are similarly available in both soft and hard varieties. Combination lenses, e.g., hybrid contact lenses, that combine various aspects of the above are also available.

[0005] Current contact lens designs are intended to fit one orientation, so for example, the parallax between the base (non-inverted) and inverted orientations, which have a defined inner surface for contact with the eye, is maximized to prevent confusion between the correct and incorrect orientations during insertion into the eye. Thus, when the lens is used in its inverted orientation, the fit, vision, and comfort of the lens are adversely affected.

[0006] EP 1364248 B1 describes a soft contact lens for placement on a wearer's eye in either a right-outward (non-inverting) or inward-outward (inverting) orientation, which has a convex anterior surface and a concave posterior surface, and which, in the inward-outward (inverting) orientation, transforms the right-outward (non-inverting) anterior convex surface into a concave posterior surface, and the right-outward (non-inverting) posterior concave surface into a convex anterior surface. According to EP 1364248 B1, the transformation is effected by bending the lens, which is accommodated by at least one formation that results in an adjustment to the surface contour of either the first or second surface. According to EP 1364248 B1, the natural resistance to turning inward (inverting) and the resulting abstract and uncontrolled curvature change can be reduced or eliminated by a relief region disposed within the lens.

[0007] Cosmetic contact lenses may include a pattern consisting of one or more elements that completely or, more preferably, partially cover the wearer's iris. These lenses may also include a limbal ring. A limbal ring is essentially an annular band of color that partially or completely covers the limbal region, the junction of the lens wearer's sclera and cornea, when the lens is centered on the eye. The incorporation of a limbal ring can make the iris appear larger, darker, and / or more defined. The combination of the limbal ring and iris pattern creates a more natural appearance of the lens on the eye. In other words, the iris pattern allows the limbal ring to blend naturally with the wearer's eye, and the combination of the iris pattern and limbal ring creates blending, depth, contrast, and definition.

[0008] Other cosmetic contact lenses focus on the sclera instead of or in addition to the iris. For example, the contact lens may include a light-colored peripheral portion, i.e., outside the iris area, that may be opaque, semi-opaque, and / or translucent. The light portion may extend from the limbus to the edge of the contact lens, creating the impression of a lighter or whiter sclera. These contact lenses may also include a limbal ring, as described above, that can make the iris appear larger, darker, and / or more defined than it would otherwise be. Summary of the Invention [Problem to be solved by the invention]

[0009] While the cosmetic contact lenses described above do indeed enhance the appearance of the eye, there is a need in the cosmetic lens area for lenses that include designs to suggest and demonstrate depth within a given pattern, to create variation within the iris area, to change the color of the iris, to enlarge the iris, and to create negative space that allows the natural iris to contribute to the overall design effect.

[0010] Furthermore, cosmetic contact lens wearers may wish to change the type of lenses they wear to change the effect, e.g., color or design. This change may occur more than once a day. This typically requires access to a new set of contact lenses, which may be expensive and / or time-consuming. Therefore, there is a need for a single contact lens that provides multiple effects. In other words, there is a need for reversible cosmetic contact lenses that have two different eye-enhancing effects depending on whether they are worn in a non-inverted or inverted orientation. Furthermore, such reversible cosmetic contact lenses should be comfortable in both the non-inverted and inverted orientations. [Means for solving the problem]

[0011] The reversible cosmetic contact lenses of the present invention overcome the limitations associated with the prior art as briefly described above.

[0012] Cosmetic contact lenses can be designed to alter the appearance of the eye in any way, including the color of the entire eye and / or different regions of the eye. While not required, cosmetic contact lenses may also be used to correct refractive errors. Cosmetic contact lenses can also have direct medical applications. For example, cosmetic contact lenses can be used to restore the appearance of damaged eyes. Cosmetic contact lenses can include clear, translucent, or opaque color highlights or tints. Tints can include organic / inorganic pigments, dyes, or special effect pigments. Printed areas on the contact lenses can include iris areas (iris patterns), limbal areas (limbal rings), scleral areas (sclera lightening), or any combination thereof. Additionally, patterns can be continuous, intermittent, or any combination thereof.

[0013] The present invention relates to cosmetic contact lenses that are reversible, thereby providing different enhancements to the eye's appearance depending on whether they are worn in a non-inverted or inverted orientation. Such reversible cosmetic contact lenses are created by incorporating multiple effect layers or design elements with different patterns, overlapping degrees, and opacity levels from various dyes, pigments, and shades into a contact lens mechanically designed for comfort in both the non-inverted and inverted orientations. Comfortable reversible cosmetic contact lenses can be produced by minimizing the differences in diameter, base curve, central thickness, and / or peripheral thickness between non-inverted and inverted contact lenses. Reversible cosmetic contact lenses also include at least one annular clear layer to encapsulate the multiple effect layers and provide high-quality optics in the optical zone of the lens. Reversible cosmetic contact lenses may also incorporate pearlescent pigments in one or more regions to create a lustrous, sparkling, or iridescent appearance in either the non-inverted or inverted orientation, or both.

[0014] The reversible cosmetic contact lenses of the present invention utilize multiple effect layers to achieve unique visual appearances in both the non-inverted and inverted orientations. Multi-layer designs may be used to enhance and / or accentuate the appearance of the eye on which the contact lens is positioned while maintaining a natural appearance. These exemplary designs may include three layers: a unique limbal design graphic, a unique inner effect graphic, and a unique outer effect graphic. These layers may be formed using any number of design elements and principles. For example, lines may be used to define shape and create contours that resemble or mimic the line structures, shapes, and contours found in the natural iris. Colors and tonal values ​​with different levels of translucency or opacity may be used to create blending and contrast, while different colors and tones may be used to create highlights and shadows to suggest depth. Space may be used to define composition; for example, positive space may be used to define and suggest effects, while negative space may be used to allow the natural iris to contribute to the overall pattern effect. Perspective of overlapping layers can be used to suggest and demonstrate depth within a given pattern. Texture can be used to create variations in the iris. As used in two-dimensional art, texture is created by the juxtaposition of light and dark features. Light and dark elements as well as overlapping elements may be used to suggest depth and form. To provide different eye enhancements in the non-inverted and inverted orientations, the multiple effect layers may also be augmented with a barrier layer, which may be continuous, intermittent, or any combination thereof, that restricts the effect (color or graphic pattern) to only either the non-inverted or inverted orientation. The efficiency of the barrier layer depends on its position and opacity and may completely or partially eliminate the effect in one orientation or another.

[0015] The reversible cosmetic contact lenses of the present invention may include any of the above-described multiple effect layers incorporating pearlescent pigments to impart a lustrous, dazzling, iridescent appearance to the wearer's eye. The pigments may be added to any region of the lens (e.g., the region covering the iris and / or sclera). For example, when used in the region covering the sclera, the combination or incorporation of pearlescent pigments results in a brighter, whiter sclera region that appears natural, with a wet, reflective appearance. The incorporation of pearlescent pigments does not significantly affect the cosmetic contact lens manufacturing process. Thus, a natural, lustrous appearance may be achieved without significant changes.

[0016] The present disclosure relates to methods for designing and optimizing reversible cosmetic contact lenses, for example, through in silico performance analysis and prototyping. By way of example, the peripheral region of the lens can be designed to minimize disparities in base curve and diameter between the home (non-inverted) and inside-out (inverted) orientations. The effect of peripheral thickness on this disparity depends on the lens diameter, base curve, and central thickness, which must be optimized along with the peripheral thickness to achieve best performance. When the base curve and diameter of the lens are comparable between the home (non-inverted) and inside-out (inverted) orientations, on-eye fit, comfort, and visual performance are expected to be comparable as well.

[0017] The base curve and diameter of the lens may be identified as determining factors for inverted fit. According to the present disclosure, one or more of the base curve and diameter of the lens may be configured between the base (non-inverted) orientation and the everted (inverted) orientation. Thus, the peripheral region of the lens may be designed to minimize the deviation in diameter or sagittal depth (dDiam or dSag) between the base (non-inverted) orientation and the everted (inverted) orientation. Furthermore, the effect of peripheral thickness may depend on the diameter, base curve, and central thickness of the lens. One or more of the diameter, base curve, and central thickness of the lens may be optimized for best performance.

[0018] In particular, the reversible cosmetic contact lenses of the present invention may comprise a body having a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a peripheral thickness, and a central thickness, wherein one or more of the diameter, base curve, peripheral thickness, or central thickness are configured such that dSag is less than 1.3% when comparing a first orientation of the body (non-inverted) in which at least a portion of the first surface abuts the wearer's eye to a second orientation of the body (inverted) in which at least a portion of the second surface abuts the wearer's eye.

[0019] Alternatively, the reversible cosmetic contact lenses of the present invention may comprise a body having a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a thickness profile, and an edge profile, wherein the edge profile and one or more of the diameter, base curve, or thickness profile are configured such that when the lens is in an inverted orientation with at least a portion of the second surface abutting the wearer's eye, the apex height, measured from the edge apex to the surface nearest the eye, is 0.020 millimeters or less.

[0020] A method for making a reversible cosmetic contact lens is disclosed. [Brief explanation of the drawings]

[0021] The foregoing and other features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings. [Figure 1] FIG. 1 is a plan view of an exemplary non-cosmetic contact lens. [Figure 2] 1 is a plan view of a first exemplary cosmetic contact lens. [Figure 3] FIG. 2 is a plan view of a second exemplary cosmetic contact lens. [Figure 4] FIG. 1 is a plan view of a third exemplary cosmetic contact lens. [Figure 5] FIG. 10 is a plan view of a fourth exemplary cosmetic contact lens. [Figure 6] 1 is a plan view of a first exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 7] FIG. 1 is a plan view of a second exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 8] FIG. 10 is a plan view of a third exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 9] FIG. 10 is a plan view of a fourth exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 10] FIG. 10 is a plan view of a fifth exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 11] FIG. 10 is a plan view of a sixth exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 12] FIG. 10 is a plan view of a seventh exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 13] FIG. 10 is a plan view of an eighth exemplary limbal ring / spoke pattern cosmetic contact lens. [Figure 14A] FIG. 2 is a plan view of a first exemplary limbal design graphic in accordance with the present invention. [Figure 14B] FIG. 2 is a plan view of a first exemplary interior effect design graphic according to the present invention. [Figure 14C] FIG. 2 is a plan view of a first exemplary exterior effect design graphic according to the present invention. [Figure 14D] 14A, 14B, and 14C are plan views of a first exemplary cosmetic contact lens according to the present invention, including the three design graphics of FIGS. [Figure 15A] FIG. 10 is a plan view of a second exemplary limbal design graphic in accordance with the present invention. [Figure 15B] FIG. 10 is a plan view of a second exemplary interior effect design graphic according to this invention. [Figure 15C] FIG. 10 is a plan view of a second exemplary exterior effect design graphic according to the present invention. [Figure 15D]15A, 15B, and 15C are plan views of a second exemplary cosmetic contact lens according to the present invention, including the three design graphics of FIGS. [Figure 16A] FIG. 10 is a plan view of a third exemplary limbal design graphic in accordance with the present invention. [Figure 16B] FIG. 10 is a plan view of a third exemplary exterior effect design graphic according to the present invention. [Figure 16C] FIG. 10 is a plan view of a third exemplary interior effect design graphic according to this invention. [Figure 16D] FIG. 16 is a plan view of a third exemplary cosmetic contact lens including the three design graphics of FIGS. 16A, B, and C in accordance with the present invention. [Figure 17A] FIG. 10 is a plan view of a fourth exemplary limbal design graphic in accordance with the present invention. [Figure 17B] FIG. 10 is a plan view of a fourth exemplary exterior effect design graphic according to the present invention. [Figure 17C] FIG. 10 is a plan view of a fourth exemplary interior effect design graphic according to the present invention. [Figure 17D] FIG. 17 is a plan view of a fourth exemplary cosmetic contact lens including the three design graphics of FIGS. 17A, B, and C in accordance with the present invention. [Figure 18A] FIG. 10 is a plan view of a fifth exemplary limbal design graphic in accordance with the present invention. [Figure 18B] FIG. 10 is a plan view of a fifth exemplary interior effect design graphic according to the present invention. [Figure 18C] FIG. 10 is a plan view of a fifth exemplary exterior effect design graphic according to the present invention. [Figure 18D] 14A, 14B, and 14C are plan views of a fifth exemplary cosmetic contact lens according to the present invention, including the three design graphics of FIGS. [Figure 19] 1 is a schematic representation of a general pad printing process. [Figure 20] 1 is a diagrammatic representation of the pad printing process in more detail. [Figure 21]FIG. 1 illustrates the layers comprising an exemplary contact lens. [Figure 22] FIG. 1 depicts an exemplary clearbase printing plate (cliche) according to the present invention. [Figure 22A] FIG. 1 is an exploded view of a portion of a clearbase printing plate according to the present invention. [Figure 22B] 1 is an exploded cross-sectional view of a clear base printing plate according to the present invention. [Figure 23] FIG. 1 is a diagram illustrating the layers comprising a cosmetic contact lens having an annular clear base layer in accordance with the present invention. [Figure 24] FIG. 1 depicts a cosmetic contact lens with a light-colored sclera with pearlescent pigment according to the present invention. [Figure 25] FIG. 1 is a plan view of an exemplary limbal ring / spoke pattern cosmetic contact lens with mica-based pearlescent pigment in the limbal region according to the present invention. [Figure 26] 1 is a plan view of an exemplary effect design graphic corresponding to the iris region of a wearer's eye with the effect design graphic including mica-based pearlescent pigments according to the present invention. [Figure 27A] 1 is a schematic diagram of a soft contact lens in a base orientation and its wrapped configuration. [Figure 27B] 1 is a schematic diagram of an inverted (e.g., inside-out) soft contact lens and its wrap configuration. [Figure 28A] 2A and 2B show distortion modeling of a conventional soft contact lens in a base orientation (FIG. 2A) and an inverted or inside-out orientation (FIG. 2B). [Figure 28B] 2A and 2B show distortion modeling of a conventional soft contact lens in a base orientation (FIG. 2A) and an inverted or inside-out orientation (FIG. 2B). [Figure 29A] 29A and 29B show distortion modeling of a soft contact lens according to the present invention (eg, having an optimized peripheral thickness), the lens in a home orientation (FIG. 29A) and an inverted or inside-out orientation (FIG. 29B). [Figure 29B]29A and 29B show distortion modeling of a soft contact lens according to the present invention (eg, having an optimized peripheral thickness), the lens in a home orientation (FIG. 29A) and an inverted or inside-out orientation (FIG. 29B). [Figure 30A] A list of the survey ratings of 14 (14) subjects is shown. [Figure 30B] A list of the survey ratings of 14 (14) subjects is shown. [Figure 31] 10 shows a plot depicting the relationship between simulated dSag and survey scores regarding the ease of identifying an inside-out lens. [Figure 32] A plot showing the resulting design space of diameters, base curves, and CTs, and their effect on the simulation metric dSag as a function of marker size (e.g., diameter for a circular marker), is shown. [Figure 33] 1 shows a model of the peripheral edge of a conventional contact lens wrapped in a cardinal orientation. [Figure 34] 1 shows a model of the peripheral edge of a conventional contact lens wrapped in an inverted or inside-out orientation. [Figure 35] 1 shows a model of the peripheral edge of a contact lens according to the present invention wrapped in a cardinal orientation. [Figure 36] 1 shows a model of the peripheral edge of a contact lens according to the present invention wrapped in an inverted or inside-out orientation. [Figure 37A] 1 shows plots based on optical analysis of a 0.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 37B] 1 shows plots based on optical analysis of a 0.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 37C] 1 shows plots based on optical analysis of a 0.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 37D] 1 shows plots based on optical analysis of a 0.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 38A]1 shows plots based on optical analysis of a −4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 38B] 1 shows plots based on optical analysis of a −4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 38C] 1 shows plots based on optical analysis of a −4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 38D] 1 shows plots based on optical analysis of a −4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 39A] 1 shows plots based on optical analysis of a +4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 39B] 1 shows plots based on optical analysis of a +4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 39C] 1 shows plots based on optical analysis of a +4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 39D] 1 shows plots based on optical analysis of a +4.00D lens in both the base orientation and the inverted or inside-out orientation. [Figure 40] Illustrates the cosmetic design changes that occur with the inversion of reversible contact lenses. [Figure 41A] 1 is a schematic diagram of an effects layer cliché according to the present invention; [Figure 41B] 1 is a schematic diagram of a patterned barrier layer cliche in accordance with the present invention. [Figure 41C] FIG. 1 is a schematic diagram of an effect cliche according to the present invention. [Figure 41D] 1 is a schematic diagram of a printing pattern according to the present invention; [Figure 42A] 1 is a schematic diagram of an effects layer cliché according to the present invention; [Figure 42B] 1 is a schematic diagram of a patterned barrier layer cliche in accordance with the present invention. [Figure 42C] FIG. 1 is a schematic diagram of an effect cliche according to the present invention. [Figure 42D]1 is a schematic diagram of a printing pattern according to the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0022] A contact lens, or contact, is simply a lens that is placed on the eye. Contact lenses are considered medical devices and may be worn for vision correction and / or for cosmetic or other therapeutic reasons. Contact lenses have been commercially available to improve vision since the 1950s. Early contact lenses were made or fabricated from hard materials and were relatively expensive and fragile. Additionally, the materials from which these early contact lenses were fabricated did not allow sufficient oxygen to permeate through the contact lens to the conjunctiva and cornea, potentially causing numerous clinical side effects. While these contact lenses are still used, they are not suitable for all patients due to their initial poor comfort. Subsequent developments in this field have led to hydrogel-based soft contact lenses, which are very common and widely used today. Silicone hydrogel contact lenses available today combine the benefits of silicone, which has very high oxygen permeability, with the proven comfort and clinical performance of hydrogels. Essentially, these silicone hydrogel-based contact lenses have higher oxygen permeability and are generally more comfortable to wear than contact lenses made from earlier hard materials. However, these new contact lenses are not without their limitations.

[0023] The present invention relates to cosmetic contact lenses that are reversible, thereby providing different enhancements to the eye's appearance depending on whether they are worn in a non-inverted or inverted orientation. Such reversible cosmetic contact lenses are created by incorporating multiple effect layers with different patterns, overlapping degrees, and opacity levels from various dyes, pigments, and shades into a contact lens mechanically designed for comfort in both the non-inverted and inverted orientations. Comfortable reversible cosmetic contact lenses can be produced by minimizing the differences in diameter, base curve, central thickness, and / or peripheral thickness between non-inverted and inverted contact lenses. Reversible cosmetic contact lenses also include at least one annular clear layer to encapsulate the multiple effect layers and provide high-quality optics in the optical zone of the lens. Reversible cosmetic contact lenses may also incorporate pearlescent pigments in one or more regions to create a lustrous, sparkling, or iridescent appearance in either the non-inverted or inverted orientation, or both.

[0024] The reversible cosmetic contact lenses of the present invention utilize multiple effect layers to achieve unique visual appearances in both the non-inverted and inverted orientations. Multi-layer designs may be used to enhance and / or accentuate the appearance of the eye on which the contact lens is positioned while maintaining a natural appearance. These exemplary designs may include three layers: a unique limbal design graphic, a unique inner effect graphic, and a unique outer effect graphic. These layers may be formed using any number of design elements and principles. For example, lines may be used to define shape and create contours that resemble or mimic the line structures, shapes, and contours found in the natural iris. Colors and tonal values ​​with different levels of translucency or opacity may be used to create blending and contrast, while different colors and tones may be used to create highlights and shadows to suggest depth. Space may be used to define composition; for example, positive space may be used to define and suggest effects, while negative space may be used to allow the natural iris to contribute to the overall pattern effect. Perspective of overlapping layers can be used to suggest and demonstrate depth within a given pattern. Texture can be used to create variations in the iris. As used in two-dimensional art, texture is created by the juxtaposition of light and dark features. Light and dark elements as well as overlapping elements may be used to suggest depth and form. To provide different eye enhancements in the non-inverted and inverted orientations, the multiple effect layers may also be augmented with a barrier layer, which may be continuous, intermittent, or any combination thereof, that restricts the effect (color or graphic pattern) to only either the non-inverted or inverted orientation. The efficiency of the barrier layer depends on its position and opacity and may completely or partially eliminate the effect in one orientation or another.

[0025] Multiple Effect Layers Referring now to FIG. 1 , a plan view of an exemplary non-cosmetic contact lens 100 is shown. The contact lens 100 includes an optic zone 102, a peripheral zone 104 surrounding the optic zone 102, a back curve surface designed to contact an individual's eye when worn, and a front curve surface opposite the back curve. The optic zone 102 is the portion of the contact lens 100 through which vision correction is obtained. In other words, the optic zone 102 provides vision correction and may be designed for specific needs, such as single-vision myopia or hyperopia correction, astigmatism vision correction, bifocal vision correction, multifocal vision correction, custom vision correction, or any other design that may provide vision correction. The peripheral zone 104 surrounds the optic zone 102 and provides mechanical stability to the contact lens 100 on the eye. In other words, the peripheral zone 104 provides mechanical properties that affect the positioning and stabilization of the contact lens 100 on the eye, including centration and orientation. Orientation is essential when the optic zone 102 includes non-rotationally symmetric features, such as astigmatism correction and / or high-order aberration correction. Some contact lens designs may utilize an optional intermediate zone between the optic zone 102 and the peripheral zone 104. The optional intermediate zone ensures that the optic zone 102 and the peripheral zone 104 blend smoothly.

[0026] 1 is circular, the lens 100 may be any convenient shape for a contact lens, such as an oval or truncated circular shape. In addition to being circular or non-circular, the contact lens 100 may be planar or non-planar.

[0027] Cosmetic contact lenses are designed to enhance or alter the appearance of the eye in which they are worn. While not required, cosmetic contact lenses may also be utilized to correct refractive errors. Additionally, cosmetic contact lenses may also have direct medical applications, such as for restoring the appearance of damaged eyes. Individuals suffering from aniridia, iris absence, pupil abnormalities, iris damage, and / or arcus senilis or arcus senilis, a disorder that lightens or discolors the limbal region of the cornea, may utilize tinted contact lenses that impart the appearance of a full iris. Cosmetic contact lenses may include translucent / transparent color enhancements, tints, opaque color tints, artificial iris patterns, limbal rings, sclera-lightening tints, and / or any combination of the above.

[0028] More specifically, cosmetic contact lenses can be used to have patterns that include limbal rings that serve to brighten the sclera and / or enhance the definition of the wearer's iris, resulting in the iris appearing larger to those viewing the lens wearer. Additionally, cosmetic contact lenses may have additional pattern elements that completely, or preferably partially, cover the wearer's iris. While cosmetic lenses can be used to enhance the irises of dark-eyed individuals, they can also be used to enhance the irises of light-eyed lens wearers as well.

[0029] Referring to FIG. 2, a first exemplary cosmetic contact lens 200 is illustrated. This lens 200 includes an optical zone and a peripheral zone within the scope of the concepts discussed above with respect to the contact lens 100 of FIG. 1, although different terms are used to describe the various regions of the cosmetic contact lens. The cosmetic contact lens 200 includes a central region 202 sized to substantially correspond to the size and location of an individual's pupil. The central region 202 typically lacks coloring or design so as not to interfere with vision. A central portion 204 surrounds the central region 202 and is sized to substantially correspond to the size and location of an individual's iris. The central portion 204 may include one or more colors and / or a pattern formed by one or more colors to enhance the appearance of the wearer's iris. A peripheral portion 206 is disposed around the central portion 204 and extends to the periphery of the contact lens 200. Peripheral portion 206 has an annular shape with an inner diameter measured from point 201 and an outer diameter measured from point 203, which may, but need not, coincide with the outer edge of the entire contact lens 200. Peripheral portion 206 may be colored, for example, white, nearly white, off-white, light yellow, light blue, light pink, light green, or any combination of the above. The light colors are positioned to blend in with the wearer's sclera.

[0030] The peripheral portion 206 is colored to enhance the appearance of the sclera. The coloring of this peripheral portion 206 may be opaque, translucent, or any color between these two, or semi-opaque. Exemplary embodiments enhance the appearance of the sclera by providing a fresh, natural appearance to the sclera. As used herein, "opaque" is understood to mean a color capable of an average light transmittance of 0 to about 50%, preferably 7 to about 50%, in the range of 380 to 780 nm. As used herein, "translucent" is understood to mean a color capable of an average light transmittance of about 50 to about 85%, preferably about 65 to about 85%, in the range of 380 to 780 nm.

[0031] FIG. 3 illustrates a second exemplary cosmetic contact lens 300. The cosmetic contact lens 300 includes a central region 302, a central portion 304 surrounding the central region 302, and a peripheral portion 306 surrounding the central portion 304 and a limbal ring 308. As described herein, the limbal ring is essentially an annular band of color that partially or completely covers the lens wearer's limbal region when the lens is centered on the eye. In some exemplary embodiments, the limbal ring may be larger to create a halo effect. In this exemplary embodiment, the coloring in the peripheral portion 306 may be graduated from opaque to translucent or transparent from an inner diameter measured from point 301 to an outer diameter measured from point 303. As with the previous exemplary embodiment, the central portion 304 may include one or more colors and / or a pattern formed by one or more colors to enhance the appearance of the wearer's iris. This combination provides the most natural iris contrast with the dark limbal ring, while providing the added benefit of light coloring being applied to the periphery 306. The limbal ring 308 can be of any suitable width or pattern that allows the ring 308 to blend naturally with the iris, central coloring / pattern 304, and light colored periphery 306. The limbal ring 308 can be translucent or opaque.

[0032] FIG. 4 shows a third exemplary cosmetic contact lens 400 with a light tint applied in the form of a geometric pattern in the peripheral region 406. The cosmetic contact lens 400 comprises a central region 402, a central portion 404 surrounding the central region 402, and a peripheral portion 406 surrounding the central portion 404 and a limbal ring 408. The difference between the contact lenses of FIGS. 3 and 4 lies in the geometric pattern in the peripheral region 406. In this exemplary cosmetic lens 400, the geometric pattern takes on the appearance of circles 410 removed from the otherwise white-tinted lens surface, such that each circle 410 touches its neighboring circle 410 at a tangent close to the limbal ring 408 and separates at the outermost periphery of the pattern to blend with the natural sclera. In a preferred embodiment, the scleral printing, the region corresponding to the peripheral region 406, transitions from opaque at the edge of the limbus to a matrix-like pattern to blend with the natural sclera. It is important to note that while this exemplary embodiment uses circles 410 as the geometric shapes, any geometric shape may be used. The pattern may also be thought of as rows and columns of crisscross-shaped, light-colored structures formed by such circles 410. As shown, circles 412 may extend into the pattern in center portion 404.

[0033] Patterning, including geometric shapes, may be formed from regularly shaped structures, as described above with respect to FIG. 4, or from a plurality of random dots or shapes 510 in both the central portion 504 and peripheral portion 506 of the cosmetic contact lens 500, as shown in FIG. 5. The central region 502 and limbal ring 508 have no patterns in this exemplary contact lens 500, e.g., no spokes or blending. Any shape convenient for conveying a realistic or enhanced color sensation can be used, particularly if such geometric shapes contribute to the desired hue or shade. The dots used may include any size and shape. The dots aid in blending the boundaries of different elements of the cosmetic contact lens.

[0034] According to another exemplary embodiment, a cosmetic lens may include a limbal ring and a plurality of tapered spokes. As described above, the limbal ring is a colored annular band that partially or substantially completely covers the lens wearer's limbal region or the junction between the cornea and the sclera when the lens is centered on the eye. Preferably, the limbal ring substantially completely covers the limbal region. The innermost boundary of the limbal ring or the edge closest to the geometric center of the lens may form a circle having a diameter of about 8 mm to about 12 mm, preferably about 9 mm to about 11 mm, with the circle centered at the geometric center of the lens. The ring may be of any suitable width, preferably about 0.5 mm to about 2.5 mm, more preferably about 0.75 mm to about 1.25 mm.

[0035] Extending inward from the innermost boundary of the limbal ring toward the geometric center of the lens are substantially triangular structures similar to the spokes of a wheel. These tapered spokes may, but preferably do not, extend across the entire iris portion of the lens, i.e., the portion of the lens that covers the iris when the lens is centered on the eye. More precisely, the spokes preferably extend inward from the innermost edge of the limbal ring, such that the innermost edge of the spoke pattern is located at least about 6 mm, more preferably at least about 7 mm, from the geometric center of the lens. The spokes may be of uniform or variable shape and size, and preferably range in length from about 1 to about 2 mm.

[0036] 6, a first exemplary embodiment of a limbal ring-tapered spoke pattern on a contact lens 600 is shown. In this exemplary embodiment, the limbal ring 602 is a black, opaque band approximately 1 mm wide. Beginning at the innermost boundary 604 of the limbal ring 602 and extending inward toward the geometric center of the contact lens 600 are a plurality of randomly arranged, tapered spokes 606, whose innermost boundary 612 forms a circle with a diameter of 7 mm measured from the geometric center of the contact lens 600. All of the spokes 606 are generally similarly configured, although preferably no spoke 606 is identical to another spoke 606. The spokes 606 are interspersed or bounded by spaces 608, which have no elements within them. The spaces 608 are also generally all similarly configured, although preferably no one of the spaces 608 is identically configured to any of the spaces 608 or any of the other spokes 606. Region 610 is an area without pattern elements; the region shown partially constitutes the iris portion of the wearer's eye, as well as the entire pupil portion of the wearer's eye, or the portion of the lens that covers the wearer's pupil when the lens is centered on the eye. As shown, region 610 is transparent, but may also be translucently or opaquely tinted. The innermost boundary 604 shown is uniform and regularly shaped, but may also be a non-uniform, irregular boundary. Similarly, the boundary 612 of the tapered spokes forms a substantially uniform boundary, but may also form a non-uniform boundary.

[0037] 7 illustrates an alternative tapered spoke pattern on a contact lens 700. In this exemplary embodiment, beginning at the innermost boundary 702 of the limbal ring 704 and extending inward toward the geometric center of the contact lens 700 are a plurality of randomly arranged tapered spokes 706. In this exemplary embodiment, the tapered spokes 706 include one or more wavy lines that taper as they move toward the geometric center of the contact lens 700. As shown, the innermost limbal ring boundary 702 is non-uniform and irregularly shaped. Region 708 is an area without pattern elements, which partially constitutes the entirety of the wearer's iris as well as the pupil of the wearer's eye, as described above.

[0038] FIG. 8 illustrates yet another tapered spoke pattern on a contact lens 800. In this exemplary embodiment, beginning at the innermost boundary 802 of the limbal ring 804 and extending inward toward the geometric center of the contact lens 800 are a plurality of spokes 806 and 808, with spoke 806 being longer than spoke 808, both of which are formed by wavy lines. As shown, spokes 806 and 808 are spaced from one another at substantially regular intervals, although they may also be spaced apart irregularly. Furthermore, each of the spokes 806 are all substantially the same shape, although they may be different shapes, as is the case with spoke 808. Element 810 is an area free of pattern elements, which partially constitutes the iris portion of the wearer's eye as well as the entirety of the wearer's pupil, as described above.

[0039] Figure 9 shows yet another exemplary tapered spoke pattern on a contact lens 900, which is a variation of the pattern shown in Figure 8. In this exemplary embodiment, the spoke pattern has a plurality of spokes 902 and 904, where spoke 902 is longer than spoke 904, and both spokes 902, 904 are formed by wavy lines. As shown, spokes 902 and 904 are randomly grouped together to form clusters 906. These clusters 906 extend from an innermost radius 908 of a limbal ring 910.

[0040] 10 shows an exemplary tapered spoke pattern on a contact lens 1000, which includes a limbal ring 1002 and extending inwardly therefrom a plurality of randomly spaced spokes 1004. In this exemplary embodiment, the spokes 1004 are bent in one or more locations.

[0041] In all of the patterns described with respect to Figures 6-10, the spokes may extend inward toward the geometric center of the lens, but preferably the innermost boundary or edge of the spoke relative to the geometric center of the lens is located at about 6.5 mm or more, preferably about 7 mm or more, from the geometric center of the lens.

[0042] In addition to the spokes and limbal ring elements, these patterns may include any of several additional components. Such components may include geometric structures, such as dots and lines, or more elaborate structures, including stripes, feather-like shapes, and the like, as well as combinations thereof. In one exemplary embodiment, as illustrated in FIG. 11 , a contact lens 1100 may include a plurality of random dots 1102 covering the spokes 1104 and the spaces between the spokes 1104. Alternatively, the dots may cover only a portion of the area of ​​the spokes and the spaces between them, such as their innermost portions or portions closest to the limbal ring 1106, or only about 1 to about 90%, preferably about 25 to 75%, of that area. As yet another alternative, the random dot pattern may have a decreasing number of dots moving inward toward the geometric center of the lens, forming a dot density gradient. The dots help blend the boundary between the limbal ring 1106 and the spokes 1104.

[0043] As yet another alternative, Figure 12 illustrates a contact lens 1200 having a plurality of random dots 1202 covering spokes 1204 and the spaces between them. The dots 1202 cover the entire spokes 1204 and the spaces between them. The spokes extend from a limbal ring 1206. The dots used in the patterns of the present invention may be of any size, preferably from about 0.060 to about 0.180 mm in diameter, and more preferably from about 0.0075 to about 0.0125 mm in diameter.

[0044] In any of the cosmetic contact lens patterns described herein, the center is preferably clear to ensure that vision is not affected, however, the central region may be a translucent / transparent or opaque color, or any combination of opaque and translucent / transparent colors.

[0045] When used in contact lenses to enhance or alter the wearer's eye color, the limbal ring element is preferably a band of the same shade of color that conceals the color of the lens wearer's limbal region, and more preferably, the concealing color is opaque. Again, a limbal ring of appropriate size may be used to create a halo effect. The remaining elements, spokes, dots, and other pattern elements may be translucent or opaque, depending on the desired cosmetic result on the eye. For purposes of this invention, "translucent" means a color that permits an average light transmittance (%T) of about 60 to about 99%, preferably about 65 to about 85%, in the 380-780 nm range. "Opaque" means a color that permits an average light transmittance (%T) of 0 to about 55%, preferably 7 to about 50%, in the 380-780 nm range.

[0046] The colors selected for each of the limbal ring and iris pattern elements are determined by the natural color of the lens wearer's iris and the desired enhancement or color alteration. Thus, the elements may be any color, including blue, green, gray, brown, black, yellow, red, or combinations thereof, in any of a variety of hues and saturations. Preferred colors for the limbal ring include black, brown, gray, black-blue, and dark green in a variety of hues and saturations.

[0047] The colors of the limbal ring, spokes, and other pattern elements may also be substantially the same or complementary to one another. For example, in FIG. 13 , a contact lens 1300 is shown including a pattern in which the limbal ring 1302 and spokes 1304 are the same color. The spokes 1306 are a different, but complementary, color to those of the limbal ring 1302 and spokes 1304. The pupil portion 1308 is another color that is complementary to the color of the limbal ring and spokes. Preferably, the pupil portion is clear, which is intended to be colorless.

[0048] The light-colored elements, including the peripheral portion, may be pure white, near-white, off-white, pale yellow, pale blue, pink, pale green, or any combination of the above colors. Preferably, these elements are matched so as not to contrast sharply with the visible portion of the sclera not covered by the lens. These colors are preferably achieved by using higher amounts of titanium dioxide (TiO2), resulting in greater opacity and contrast. Further pigments include small amounts of black iron oxide, brown iron oxide, yellow iron oxide, red iron oxide, titanium dioxide, etc., and combinations thereof, to adjust the whiter colored elements. In addition to these pigments, soluble and insoluble dyes, including dichlorotriazine and vinyl sulfone-based dyes, may also be used. One exemplary embodiment is a colorant having 10%-20% TiO2 and 80%-90% transparent binding polymer to provide adequate translucency.

[0049] Generally, the colored elements can be made from any organic or inorganic pigment, or combinations of these pigments, suitable for use in contact lenses. Opacity can be adjusted by varying the concentration of pigment and titanium dioxide used, with higher amounts resulting in higher opacity. Exemplary organic pigments include phthalocyanine blue, phthalocyanine green, carbazole violet, vat orange #1, and the like, and combinations thereof. Examples of useful inorganic pigments include black iron oxide, brown iron oxide, yellow iron oxide, red iron oxide, titanium dioxide, and the like, and combinations thereof. In addition to these pigments, soluble and insoluble dyes, including dichlorotriazine and vinyl sulfone dyes, may also be used. Useful dyes and pigments are commercially available.

[0050] In accordance with the present invention, contact lenses including multi-layer designs may be used to enhance the appearance of the eye on which the contact lens is positioned while maintaining a natural appearance. Each exemplary design includes three layers: a unique limbal design graphic, a unique inner effect graphic, and a unique outer effect graphic. The order and colors of printing the various layers have an impact on the final design, as described in detail below. Additionally, each of the three layers may vary in color and design to create a unique eye appearance.

[0051] These layers may be formed using any number of design elements and principles. For example, lines can be used to define shapes and create contours that resemble or mimic the line structures, shapes, and contours found in natural irises. Colors and tonal values ​​with different levels of translucency or opacity can be used to create blends and contrasts, while different colors and tones can be used to suggest depth by creating highlights and shadows. Space can be used to determine composition; for example, positive space can be used to define and suggest effects, while negative space can be used to allow the natural iris to contribute to the overall pattern effect. Perspective of overlapping layers can be used to suggest and demonstrate depth within a given pattern. Texture created through contrasts of color and shape can be used to create variations in the iris. As used in two-dimensional art, texture is created through the use of light and dark features. Light and dark elements may be used to suggest depth and form.

[0052] As noted above, the present invention provides additional depth and variation in the overall pattern using three distinct layers. The limbal design graphic is the portion of the overall pattern that surrounds the outer diameter of the iris and is closest to the sclera and is intended to highlight, emphasize, and / or define the limbal region of the eye, but it also includes elements that extend into the iris. The inner effect graphic layer is the portion of the overall pattern that is intended to highlight the iris, but may also include portions that contribute to highlighting, highlighting, and / or defining the limbal region of the eye. The outer effect graphic layer is the portion of the overall pattern that is intended to highlight the iris, but may also include portions that contribute to highlighting, highlighting, and / or defining the limbal region of the eye. Using the multi-layer approach of the present invention, different levels of transparency and / or opacity can be created using overlapping and non-overlapping translucent layers.

[0053] Various design elements described above can be used to achieve a variety of effects. Similar to the limbal ring / tapered spoke pattern described above, multi-layer designs in accordance with the present invention can also employ similar features. For example, spokes, fingers, hair-like structures, as well as similar structures and / or dots, can be used to blend the limbal zone of the same shade into the iris. Additionally, various other geometric shapes, including those found in the natural iris, may be incorporated into the various layers.

[0054] Referring to FIG. 14A , a first exemplary embodiment of a limbal design graphic 1400 according to the present invention is shown. In this exemplary embodiment, the limbal design graphic 1400 includes a translucent annular band 1402 approximately 0.89 mm wide. Connected to the innermost boundary 1404 of the annular band 1402 and extending therefrom toward the geometric center of the limbal design graphic 1400 are a plurality of long, medium-length, and short ciliary structures 1406. Some of the ciliary structures have branches 1408 from the main structure 1406. Additional ciliary structures 1410 not connected to the translucent band 1402 are interspersed among the other ciliary structures 1406. These ciliary structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The translucent annular band 1402 is designed to cover and highlight the wearer's limbal region, while the similarly translucent protruding structures 1406, 1408, and 1410 are designed to highlight the wearer's iris and blend the translucent annular band 1402 with the wearer's iris. The spaces between the ciliary structures create shapes, including colored shapes and features and exposed iris, depending on the overlapping and underlying elements. The center portion 1412 of the design graphic 1400 may be clear, as this portion of the design corresponds to the pupil. However, it is important to note that a tint may also be used in this center portion 1412. Additionally, the spaces between the elements of the design may be clear or colored.

[0055] In this exemplary embodiment, the overall limbal design graphic 1400 is a translucent medium brown formed from a composition including red iron oxide, titanium dioxide, transoxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in proportions that produce a color in the brown to black family. It is important to note that while the limbal design graphic 1400 is translucent in this exemplary embodiment, other designs may include opaque elements or a combination of opaque and translucent elements. This limbal design graphic 1400 is printed using techniques described in more detail below, and it is printed first. In other words, it is the first graphic layer of the overall design that will be incorporated into the lens. The printing order will affect the overall design, as will be described in more detail below.

[0056] FIG. 14B illustrates a first exemplary embodiment of an interior effect design graphic 1420 according to the present invention. The interior effect graphic 1420 includes an annular band comprising a geometrically shaped wave-like ring structure 1422 having a plurality of rounded troughs 1424 and pointed peaks 1426 with negative space 1428 therein (the negative space exists as closed features within the printed element and as open shapes outside the printed element), i.e., no pattern, and variously shaped elements, and a plurality of elongated substantially elliptical structures 1430 of various lengths and widths interspersed within the troughs 1424. The substantially elliptical structures 1430 may or may not have tapered ends. The overall effect may resemble a sinusoidal pattern or mimic the natural iris. More specifically, the overall effect is designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The interior effect design graphic 1420 is designed to cover and highlight the wearer's iris and at least partially overlaps the translucent annular band 1402 of the limbal design graphic 1400. Additionally, the interior effect design graphic 1420 covers the protruding structures 1406, 1408, and 1410 of the limbal design graphic 1400 in a manner that includes overlapping translucent segments, while simultaneously filling some or a portion of the negative space between the protruding structures 1406, 1408, and 1410. The overlapping translucent pigment segments create additional hues within the pattern, which may be darker or lighter depending on the color and different levels of translucency used in the underlying individual's anatomy. The spaces between the elements of this pattern create shapes, including colored shapes and features and exposed irises, depending on the overlapping and underlying elements. The center portion 1432 of the design graphic 1420 may be transparent, as this portion of the design corresponds to the pupil. However, it is important to note that tints may also be used in this area. Additionally, the negative space may be clear or colored.

[0057] In this exemplary embodiment, the entire interior effect design graphic 1420 is a translucent orange formed from a composition including red iron oxide, transoxide yellow, brown iron oxide, and transoxide pigment in ratios that create a color in the orange family. The orange family includes yellow and gold. These colors or colors in this family are intended to accentuate the underlying natural iris color of individuals with darker eyes, such as brown, dark brown, or dark maroon. Different colors would be used for individuals with lighter eyes, such as blue, green, light maroon, or gray. It is important to note that while the interior effect graphic 1420 includes translucent elements, other embodiments may include opaque elements and / or a combination of translucent and opaque elements. This interior effect graphic 1420 is printed using techniques described in detail below, being printed second after the limbal design graphic 1400. In other words, the interior effect graphic 1420 is printed after and on top of the limbal design graphic 1400. This printing order is from a manufacturing standpoint. From an observer's standpoint, this layer, the interior effect design graphic 1420, appears behind the graphic 1400. The outer diameter of the interior effect design graphic 1420 is smaller than the outer diameter of the limbus design graphic 1400, but the inner diameters are substantially equal.

[0058] 14C illustrates a first exemplary embodiment of an external effect design graphic 1440 according to the present invention. In this exemplary embodiment, the external effect design graphic 1440 includes a translucent annular band 1442 approximately 1.44 mm wide. Connected to and extending from the innermost boundary 1444 of the translucent annular band 1442 are a plurality of long, medium-length, and short substantially triangular structures 1446. Some of the substantially triangular structures meet at their apexes, forming enclosed spaces 1448. The external design graphic 1440 also includes a plurality of lines 1450 not connected to the translucent annular band 1442, interspersed among the substantially triangular structures, and oriented in the same direction, i.e., toward the geometric center of the external effect design graphic 1440. These structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the translucent annular band 1442 includes a comb-like structure 1452 that changes the appearance of the annular band 1442 to a more ambiguous structure. The comb-like structure 1452 is intended to soften and blend the overlapping lines created by layering translucent colors from three layers: the limbal design graphic 1400, the inner effect design graphic 1420, and the outer effect design graphic 1440. The outer effect design graphic 1440 is designed to cover and highlight the translucent annular band 1402 of the limbal design graphic 1400, as well as the entire inner effect design graphic 1420 and the protruding structures 1406, 1408, and 1410 of the limbal design graphic 1400. The outer layer design graphic 1440 fills in the more negative space, and the overlapping sections or positive space create areas of additional hues, areas of different levels of opacity, and a distinct and different design separate from any single layer or graphic. Additionally, the negative space between overlapping areas works in conjunction with the natural iris to create shapes and patterns that lend themselves to blending and aesthetic effect. The negative space between elements of this design creates shapes, including colored shapes and features as well as exposed iris, depending on the overlapping and underlying elements.The central portion 1454 may be clear, as this portion of the lens corresponds to the pupil. However, it is important to note that a tint may also be used in this section. Additionally, the negative space between elements may be colored. The comb-like structure 1452 varies the outer diameter of the annular band 1402 of the limbal design graphic by creating a shape that breaks up the hard lines of the translucent limbal design graphic 1400.

[0059] In this exemplary embodiment, the entire outer effect design graphic 1440 is translucent black, formed from a composition including brown iron oxide and black iron oxide pigments. In this exemplary embodiment, where the outer effect design graphic 1440 and the limbal design graphic 1400 overlap, they create darker, more defined / opaque areas, while the non-overlapping portions of the design remain more translucent, providing a translucent blend from opaque to transparent. This technique allows for blending with the natural iris. In this exemplary embodiment, the outer effect design graphic 1440 includes a translucent design, but in other embodiments, the design may include opaque elements and / or a combination of translucent and opaque elements. The outer effect graphic 1440 is printed using techniques described in detail below and is printed third and on top of the inner effect graphic layer 1420. The printing order is from a manufacturing perspective. From the viewer's perspective, this layer appears behind the inner effect design graphic 1420. The outer diameter of the external effect design graphic 1440 is smaller than the outer diameter of the limbus design graphic 1400, but the inner diameters are substantially equal.

[0060] 14D shows a first exemplary embodiment of a cosmetic contact lens 1460 including all three layers or design graphics 1400, 1420, and 1440 printed in the order described above. The printing order is described from a manufacturing perspective, but when a viewer looks at the contact lens on the eye, the visual effect is that they see the layers or design graphics in the reverse order from that described in the printing. As shown, the overlapping layers include different colors, different levels of translucency, different hues, different levels of lightness, different levels of darkness, and patterns that create unique structures. Varying either the printing order or the color or both results in different designs, as described in more detail below. Additionally, varying the level of translucency can also affect the overall design in terms of hue, blending, texture, and contrast.

[0061] The overall design created by the three layers comprises an annular structure with an inner diameter of approximately 6.5 mm and an outer diameter ranging from approximately 12.675 mm to approximately 12.8 mm. This annular structure is similar in design to the iris structure of the eye. The open or negative space in the center of the lens corresponds to the pupil area or optical zone of the eye and is preferably clear so as not to interfere with vision. However, as noted above, this area may also be tinted and optionally negative space.

[0062] Referring to FIG. 15A , a second exemplary embodiment of a limbal design graphic 1500 according to the present invention is shown. In this exemplary embodiment, the limbal design graphic 1500 includes a translucent annular band 1502 approximately 0.89 mm wide. Connected to the innermost boundary 1504 of the annular band 1502 and extending therefrom toward the geometric center of the limbal design graphic 1500 are a plurality of long, medium-length, and short ciliary structures 1506. Some of the ciliary structures have branches 1508 from the main structure 1506. Additional ciliary structures 1510 not connected to the opaque band 1502 are interspersed among the other ciliary structures 1506. These ciliary structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The translucent annular band 1502 is designed to cover and highlight the wearer's limbal region, while the protruding structures 1506, 1508, and 1510 are designed to highlight the wearer's iris and blend the annular band 1502 with the iris. The protruding structures 1506, 1508, and 1510 are also translucent. The spaces between the ciliary structures create shapes, including colored shapes and features and the exposed iris, depending on the overlapping and underlying elements. The center portion 1512 of the design graphic 1500 may be clear, as this portion of the design corresponds to the pupil. However, it is important to note that a tint may also be used in this center portion 1512. Additionally, the spaces between the elements of the design may be clear or colored.

[0063] In this exemplary embodiment, the overall limbal design graphic 1500 is a translucent black formed from black iron oxide pigment. While the limbal design graphic 1500 is translucent in this exemplary embodiment, it is important to note that other designs may include opaque elements or a combination of opaque and translucent elements. This limbal design graphic 1500 is printed using techniques described in more detail below, and it is printed first. In other words, it is the first graphic layer of the overall design that will be incorporated into the lens. The order of printing will affect the overall design, as will be described in more detail below.

[0064] FIG. 15B illustrates a second exemplary embodiment of an interior effect design graphic 1520 according to the present invention. The interior effect graphic 1520 includes an annular band comprising a geometrically shaped wave-like ring structure 1522 having a plurality of rounded troughs 1524 and pointed peaks 1526 with negative space 1528 therein (the negative space exists as a closed feature within the printed element and as an open shape outside the printed element), i.e., no pattern, and variously shaped elements, and a plurality of elongated substantially elliptical structures 1530 of various lengths and widths interspersed within the troughs 1524. The substantially elliptical structures 1530 may or may not have tapered ends. The overall effect may resemble a radial pattern or mimic a natural iris. More specifically, the overall effect is designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The interior effect design graphic 1520 is designed to cover and highlight the wearer's iris and at least partially overlaps the translucent annular band 1502 of the limbal design graphic 1500. Additionally, the interior effect design graphic 1520 covers the protruding structures 1506, 1508, and 1510 of the limbal design graphic 1500 in a manner that includes overlapping translucent segments, while simultaneously filling some or a portion of the negative space between the protruding structures 1506, 1508, and 1510. The overlapping translucent pigment segments create additional hues within the pattern, which may be darker or lighter depending on the color and different levels of translucency used in the underlying individual's anatomy. The spaces between the elements of this pattern create shapes, including colored shapes and features and exposed irises, depending on the overlapping and underlying elements. The center portion 1532 of the design graphic 1520 may be transparent, as this portion of the design corresponds to the pupil. However, it is important to note that tints may also be used in this area. Additionally, the spaces between the elements of the design may be clear or colored.

[0065] In this exemplary embodiment, the entire interior effect design graphic 1520 is a translucent medium brown formed from a composition including red iron oxide, titanium dioxide, transoxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in proportions that create a gold to brown color. The colors used are intended to accentuate or otherwise enhance the underlying natural iris color. Different colors are used for different colored eyes. In alternative exemplary embodiments, the interior effect design graphic 1520 may include opaque and / or a combination of opaque and translucent elements. This interior effect design graphic 1520 is printed using techniques described in detail below and is printed second, after the limbal design graphic 1500. In other words, the interior effect graphic 1520 is printed after and on top of the limbal design graphic 1500. This printing order is from a manufacturing perspective. From the viewer's perspective, this graphic layer 1520 appears behind the limbal design graphic 1500. The outer diameter of the inner effect design graphic 1520 is smaller than the outer diameter of the limbal design graphic 1500, but the inner diameters are substantially equal.

[0066] FIG. 15C illustrates a second exemplary embodiment of an outer effect design graphic 1540 according to the present invention. In this exemplary embodiment, the outer effect design graphic 1540 includes a translucent annular band 1542 having a width of approximately 1.44 mm. Connected to and extending from the innermost boundary 1544 of the translucent annular band 1542 are a plurality of long, medium-length, and short substantially triangular structures 1546. Some of the substantially triangular structures meet at their apexes, forming enclosed spaces 1548. The outer effect design graphic 1540 also includes a plurality of lines 1550, not connected to the opaque annular band 1542, interspersed among the substantially triangular structures and oriented in the same direction, i.e., toward the geometric center of the outer effect design graphic 1540. These structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the translucent annular band 1542 includes a comb-like structure 1552 that changes the appearance of the annular band 1542 to a more ambiguous structure. The comb-like structure 1552 is intended to soften and blend the overlapping lines created by layering translucent colors from three layers: the limbal design graphic 1500, the interior effect graphic 1520, and the exterior effect design graphic 1540. The exterior effect design graphic 1540 is designed to cover and highlight the translucent annular band 1502 of the limbal design graphic 1500, as well as the entire interior effect design graphic 1520 and the protruding structures 1506, 1508, and 1510 of the limbal design graphic 1500. The exterior effect design graphic 1540 fills in the more negative space, and the overlapping sections or positive space create areas of additional hues, areas of different levels of opacity, and a distinct and different design separate from any single layer or graphic. Additionally, the negative space between overlapping areas works in conjunction with the natural iris to create shapes and patterns that lend themselves to blending and aesthetic effect. The negative space between elements of this design creates shapes, including colored shapes and features as well as exposed iris, depending on the overlapping and underlying elements.The central portion 1554 may be clear, as this portion of the lens corresponds to the pupil. However, it is important to note that a tint may also be used in this section. Additionally, the negative space between elements may be clear or tinted. The comb-like structure 1552 alters the appearance of the outer diameter of the annular band 1502 of the limbal design graphic by making it less noticeable.

[0067] In this exemplary embodiment, the entire outer effect design graphic 1540 is a translucent gray formed from a composition including titanium dioxide and black iron oxide pigments. In this exemplary embodiment, where the outer effect design graphic 1540 and the limbal design graphic 1500 overlap, they create darker, more defined / opaque areas, while the non-overlapping portions of the design remain more translucent, providing a translucent blend from opaque to transparent. This technique allows for blending with the natural iris. The outer effect design graphic 1540 includes a translucent design; however, other designs may incorporate opaque elements and / or a combination of opaque and translucent elements. The outer effect graphic 1540 is printed using techniques described in detail below, third in order after the inner effect graphic 1520 and printed on top of the inner effect graphic 1520. The printing order is from a manufacturing perspective. From the viewer's perspective, this layer appears behind the inner effect design graphic 1520. The outer diameter of the external effect graphic 1554 is smaller than the outer diameter of the limbal design graphic 1500, but the inner diameters are substantially equal.

[0068] 15D shows a second exemplary embodiment of a cosmetic contact lens 1560 including all three layers or design graphics 1500, 1520, and 1540 printed in the order described above. The printing order is described from a manufacturing perspective, but when a viewer looks at the contact lens on the eye, the visual effect is that they see the layers or design graphics in the reverse order from that described in the printing. As shown, the overlapping layers include different colors, different hues, different levels of lightness, different levels of darkness, and patterns that create unique structures. Variations in either the printing order or the colors will result in different designs. Additionally, any of these variations can affect the level of translucency, which can affect the overall design.

[0069] The overall design created by the three layers comprises an annular structure with an inner diameter of approximately 6.0 mm and an outer diameter ranging from approximately 12.50 mm to approximately 12.775 mm. This annular structure is similar in design to the iris structure of the eye. The open or negative space in the center of the lens corresponds to the pupil area or optical zone of the eye and is preferably clear so as not to interfere with vision. However, as noted above, this area, as well as any negative space, may be tinted.

[0070] Referring to FIG. 16A , a third exemplary embodiment of a limbal design graphic 1600 according to the present invention is shown. In this exemplary embodiment, the limbal design graphic 1600 includes a translucent annular band 1602 approximately 0.89 mm wide. Connected to the innermost boundary 1604 of the translucent annular band 1602 and extending therefrom toward the geometric center of the limbal design graphic 1600 are a plurality of long, medium-length, and short ciliary structures 1606. Some of the ciliary structures have branches 1608 from the main structure 1606. Additional branch-like structures 1610, which create hook-like structures, are intended to mimic the edges of the pupillary muscle. As previously mentioned, all of these structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The translucent annular band 1602 is designed to cover and highlight the wearer's limbal region, while the protruding structures 1606, 1608, and 1610 are designed to highlight the wearer's iris and blend the translucent annular band 1602 with the wearer's iris. The ciliary structures are also translucent. The spaces between the ciliary structures create shapes, including colored shapes and features and exposed iris, depending on the overlapping and underlying elements. The center portion 1612 of the design graphic 1600 may be clear, as this portion of the design corresponds to the pupil. However, it is important to note that a tint may also be used in this center portion 1612. Additionally, the spaces between the elements of the design may be clear or colored.

[0071] In this exemplary embodiment, the overall limbal design graphic 1600 is a translucent dark brown formed from a composition including brown iron oxide and black iron oxide pigments in ratios that produce a color in the brown to black family. The limbal design graphic 1600 includes translucent elements, although in other exemplary embodiments, it may include opaque elements and / or a combination of translucent and opaque elements. This limbal design graphic 1600 is printed using techniques described in more detail below, and it is printed first. In other words, it is the first graphic design of the overall design that will be incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0072] FIG. 16B illustrates a third exemplary embodiment of an exterior effect design graphic 1620 according to the present invention. It is important to note that the printing order of the interior and exterior effect graphics is changed in this exemplary embodiment. In the above exemplary embodiment, the interior effect design graphic is between the limbus design graphic and the exterior effect design graphic. In this exemplary embodiment, the exterior effect design graphic 1620 includes a translucent annular band 1622 approximately 1.44 mm wide. Connected to and extending from the innermost boundary 1624 of the translucent annular band 1622 are a plurality of long, medium-length, and short substantially triangular structures 1626. Some of the substantially triangular structures meet at their apexes, forming an enclosed space 1628. The exterior effect design graphic 1620 also includes a plurality of lines 1630, not connected to the opaque annular band 1622, interspersed among the substantially triangular structures and oriented in the same direction, i.e., toward the geometric center of the exterior effect design graphic 1620. Some of the substantially triangular structures or protrusions 1626 have branches 1632, and some of the lines 1630 have branches 1634. All of these structures are designed to resemble natural structures in the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the annular zone 1622 includes a comb-like structure 1636 that changes the appearance of the annular zone 1622 to a less defined structure. The comb-like structure 1636 is intended to blur and blend the overlapping lines created by overlapping translucent colors from two layers. All of the elements of the exterior effect design graphic 1620 are translucent, although in other embodiments, these elements may be opaque and / or a combination of translucent and opaque. The exterior effect design graphic 1620 is designed to cover and highlight the translucent annular zone 1602 of the limbal design graphic 1600. In addition, the external effect design graphic 1620 covers the protruding structures 1606, 1608, and 1610 of the limbus design graphic 1600 in a manner that has overlapping sections, while filling some or a portion of the negative space between the protruding structures 1606, 1608, and 1610.The exterior effect design graphic 1620 fills in more negative space, and overlapping sections or positive spaces create areas of additional hues, areas of different levels of opacity, and distinct designs separate from any single layer. Additionally, the negative space between overlapping areas creates shapes and patterns that work in conjunction with the natural iris for blending and cosmetic effect. The negative space between elements of this design creates shapes, including colored shapes and features as well as exposed iris, depending on the overlapping and underlying elements. The center portion 1638 may be clear, as this portion of the lens corresponds to the pupil. However, it is important to note that tints may also be used in this area. Additionally, coloring may be used in negative spaces as well. The comb-like structure 1636 alters the outer diameter of the annular band 1602 of the limbal design graphic 1600 by reducing its appearance.

[0073] In this exemplary embodiment, the entire outer effect design graphic 1620 is translucent brown, formed from a composition including red iron oxide, titanium dioxide, transoxide yellow, phthalocyanine green, yellow iron oxide, brown iron oxide, and black iron oxide pigments. In this exemplary embodiment, where the outer effect design graphic 1620 and the limbal design graphic 1600 overlap, they create darker, more defined / opaque areas, while the non-overlapping portions of the design remain more translucent, providing a translucent blend from opaque to transparent. This technique allows for blending with the natural iris. In this exemplary embodiment, the outer effect design graphic 1620 includes a translucent design; however, in other exemplary embodiments, the design may include opaque elements and / or a combination of translucent and opaque elements. The outer effect design graphic 1620 is printed using techniques described in detail below, printed second on top of the limbal design graphic layer 1600. The printing order is from a manufacturing perspective. From the viewer's perspective, this layer appears behind limbal design graphic 1600. The outer diameter of external effect design graphic 1620 is smaller than the outer diameter of limbal design graphic 1600, but the inner diameters are substantially equal.

[0074] FIG. 16C illustrates a third exemplary embodiment of an interior effect design graphic 1640 according to the present invention. In this exemplary embodiment, the interior effect design graphic 1640 includes a translucent annular band 1642 approximately 2.08 mm wide. As can be readily seen from the illustration, the annular band 1642 is much wider in this embodiment than the other annular bands. Connected to and extending from the innermost boundary 1644 of the annular band 1642 are a plurality of substantially triangular structures or protrusions 1646 that extend inward toward the geometric center of the interior effect design graphic 1640. These protrusions are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the annular band 1642 includes a non-uniform surface 1648 that blurs / blends areas of overlapping hard lines, transforming the appearance of the annular band 1642 into a less defined structure. It is less pronounced than the comb-like structure 1636 of the outer effect design graphic 1620. The inner effect design graphic 1640 is designed to cover and highlight the translucent annular bands 1602 and 1622 of the limbal design graphic 1600 and the outer effect design graphic 1620, respectively. Again, a substantially triangular structure 1646 overlaps and fills the spaces between the protrusions 1606, 1608, and 1610 of the limbal design graphic 1600 and the elements 1626, 1628, and 1630 of the outer effect design graphic 1620. The overlapping translucent pigment segments create additional hues within the pattern, which may be darker or lighter depending on the colors used and different levels of translucency for an individual's underlying structure. The spaces between the elements of this pattern create shapes, including colored shapes and features and exposed irises, depending on the overlapping and underlying elements. The center portion 1650 of the interior effect graphic 1640 may be transparent since this portion of the design corresponds to the pupil, however, color tint may be used in the center portion 1650 as well as the negative space.

[0075] In this exemplary embodiment, the entire interior effect design graphic 1640 is a translucent yellow formed from a composition including transoxide yellow, yellow iron oxide, brown iron oxide, and transoxide pigment in proportions that create a color in the yellow family. As noted above, yellow is part of the orange family, which also includes gold. These colors are intended to highlight the underlying natural iris color for individuals with brown or dark eyes. Different colors would be used for lighter eye colors. This interior effect design graphic 1640 is printed using techniques described in detail below and is printed third after the exterior effect graphic 1620. In other words, the interior effect graphic 1640 is printed after and on top of the exterior design graphic 1620. The printing order is from a manufacturing perspective. From the viewer's perspective, this layer appears behind the outer layer. While the interior effect design graphic 1640 includes translucent elements, in alternative exemplary embodiments, it may include opaque elements and / or a combination of opaque and translucent elements. The outer diameter of the inner effect design graphic 1640 is smaller than the outer diameter of the limbus design graphic 1600, but the inner diameters are substantially equal.

[0076] FIG. 16D shows a third exemplary embodiment of a cosmetic contact lens 1660 that includes all three layers or design graphics 1600, 1620, and 1640 printed in the order described above. It is important to note that the printing order differs from the other two exemplary embodiments described above because the inner and outer effect layers are switched. Additionally, all three design graphics have annular bands that create a unique limbal ring design pattern. While the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the visual effect is that they see the layers or design graphics in the reverse order used in printing. As shown, the overlapping layers include different colors, different hues, different levels of lightness, different levels of darkness, and patterns that create unique structures. Varying either the printing order or the color results in different designs. Additionally, variations in translucency can also be achieved.

[0077] The overall design created by the three layers comprises an annular structure with an inner diameter of approximately 6.7 mm and an outer diameter ranging from approximately 12.650 mm to approximately 12.725 mm. This annular structure is similar in design to the iris structure of the eye. The open or negative space in the center of the lens corresponds to the pupil area or optical zone of the eye and is preferably clear so as not to interfere with vision. However, as noted above, this area may also be tinted, or may be the negative space between elements.

[0078] Referring to FIG. 17A , a fourth exemplary embodiment of a limbal design graphic 1700 according to the present invention is shown. In this exemplary embodiment, the limbal design graphic 1700 includes a translucent annular band 1702 approximately 0.85 mm wide. Connected to the innermost boundary 1704 of the translucent annular band 1702 and extending therefrom toward the geometric center of the limbal design graphic 1700 are a plurality of geometric structures 1706 resembling crypts in the natural iris. Additional geometric structures 1708 also extend toward the geometric center of the limbal design graphic 1700 but are not attached to the translucent annular band 1702. Crypts are physical features found on the natural iris that are a series of openings located on either side of the annulus of contraction. Crypts on the base of the iris are additional openings that can be observed near the outermost portion of the ciliary portion of the iris. As noted above, all of the elements in the design graphic are designed to resemble natural structures in the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The translucent annular band 1702 is designed to cover and highlight the wearer's limbal region, while the protruding structures 1706 and 1708 are designed to highlight the wearer's iris and blend the annular band 1702 with the iris. The spaces between the geometric structures create shapes, including colored shapes and features and exposed iris, depending on the overlapping and underlying elements. The central portion 1710 of the design graphic 1700 may be transparent, as this portion of the area corresponds to the pupil. However, it is important to note that tint may also be used in this central portion 1710. In addition, tint may be used in the spaces between the elements.

[0079] In this exemplary embodiment, the overall limbal design graphic 1700 is a translucent dark brown formed from a composition including brown iron oxide and black iron oxide pigments in ratios that produce a color in the brown to black family. While the limbal design graphic is translucent, in other exemplary embodiments, it may include opaque elements and / or a combination of opaque and translucent elements. This limbal design graphic 1700 is printed using techniques described in more detail below, and it is printed first. In other words, it is the first graphic design of the overall design that will be incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0080] FIG. 17B illustrates a fourth exemplary embodiment of an exterior effect design graphic 1720 according to the present invention. It is important to note that the printing order of the interior and exterior effect graphics is changed in this exemplary embodiment relative to the first two exemplary embodiments. In this exemplary embodiment, the exterior effect design graphic 1720 includes a translucent annular band 1722 approximately 0.89 mm wide. Connected to and extending from the innermost boundary 1724 of the translucent annular band 1722 are a plurality of long, medium-length, and short substantially triangular structures 1726. Some of the substantially triangular structures meet at their apexes, forming enclosed spaces 1728. The exterior effect design graphic 1720 also includes a plurality of lines 1730 not connected to the opaque annular band 1722, interspersed among the substantially triangular structures, and oriented in the same direction, i.e., toward the geometric center of the exterior effect design graphic 1720. Some of the substantially triangular structures or protrusions 1726 have branches 1732, and some of the lines 1730 have branches 1734. All of these structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the annular zone 1722 includes comb-like structures 1736 that change the appearance of the translucent annular zone 1722 to a less defined structure. The comb-like structures 1736 are intended to blur and blend the overlapping lines created by layering translucent colors from other layers. The exterior effect design graphic 1720 is designed to cover and highlight the translucent annular zone 1702 of the limbal design graphic 1700. Additionally, the outer effect design graphic 1720 covers the protruding structures 1706 and 1708 of the limbal design graphic 1700 in a manner that has overlapping sections, while also filling some or a portion of the negative space between the protruding structures 1706 and 1708. The outer effect design graphic 1720 fills in more negative space, and the overlapping sections or positive space create areas of additional hues, areas of different levels of opacity, and distinct and different designs separate from any single layer.Additionally, the negative space between overlapping areas works in conjunction with the natural iris to create shapes and patterns that aid in blending and cosmetic effects. The negative space between design elements creates shapes depending on the overlapping and underlying elements, such as colored shapes and features and exposed iris. The center portion 1738 may be clear since this portion of the lens corresponds to the pupil. However, it is important to note that tints may also be used. Additionally, tints may be used in the negative space of the design. The comb-like structure 1736 alters the outer diameter of the annular band 1702 of the limbal design graphic 1700 by making it less noticeable in appearance.

[0081] In this exemplary embodiment, the entire outer effect design graphic 1720 is translucent brown, formed from a composition including red iron oxide, titanium dioxide, transoxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in ratios that create a brown to black color family. In this exemplary embodiment, where the outer effect design graphic 1720 and the limbal design graphic 1700 overlap, they create darker, more defined / opaque areas, while the non-overlapping portions of the design have a more translucent coloring, providing a translucent blend from opaque to transparent. This technique allows for blending with the natural iris. While the outer effect design graphic 1720 includes translucent elements, other embodiments may include opaque elements and combinations of translucent and opaque elements. This outer effect graphic 1720 is printed using techniques described in detail below, being printed second on top of the limbal effect graphic layer 1700. The printing order is from a manufacturing perspective. From the viewer's perspective, this layer or graphic appears behind the limbal layer 1700. The outer diameter of the external effect design graphic 1720 is smaller than the outer diameter of the limbus design graphic 1700, but the inner diameters are substantially equal.

[0082] FIG. 17C illustrates a fourth exemplary embodiment of an interior effect design graphic 1740 according to the present invention. In this exemplary embodiment, the interior effect design graphic 1740 includes a translucent annular band 1742 approximately 2.03 mm wide. As can be readily seen from the illustration, the annular band 1742 is much wider in this embodiment than the other annular bands. Connected to and extending from the innermost boundary 1744 of the translucent annular band 1742 are a plurality of substantially triangular structures or protrusions 1746 that extend inward toward the geometric center of the interior effect design graphic 1740. These protrusions are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the annular band 1742 includes a non-uniform surface 1748 that blurs / blends areas of overlapping hard lines, transforming the appearance of the opaque annular band 1742 into a more indistinct structure. It is less pronounced than the comb-like structure 1736 of the outer effect design graphic 1720. The inner effect design graphic 1740 is designed to cover and highlight the translucent annular bands 1702 and 1722 of the limbal design graphic 1700 and the outer effect design graphic 1720, respectively. Again, the substantially triangular structure 1746 overlaps and fills the spaces between the protrusions 1706 and 1708 of the limbal design graphic 1700 and the elements 1726, 1728, and 1730 of the outer effect design graphic 1720. The overlapping translucent pigment segments create additional hues within the pattern, which may be darker or lighter depending on the colors used and different levels of translucency for an individual's underlying structure. The spaces between the elements of this pattern create shapes, including colored shapes and features and exposed irises, depending on the overlapping and underlying elements. The center portion 1750 of the interior effect graphic 1740 may be transparent since this portion of the design corresponds to the pupil, however, it is important to note that tint may be used in this area or zone as well as in the negative space of the design.

[0083] In this exemplary embodiment, the entire interior effect design graphic 1740 is translucent brown, formed from a composition including red iron oxide, phthalocyanine blue, titanium dioxide, transoxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in proportions that produce a brown to black color. This interior effect design graphic 1740 is printed using techniques described in detail below, and is printed third after the exterior effect graphic 1720. In other words, the interior effect design graphic 1740 is printed after and on top of the exterior design graphic 1720. The printing order is from a manufacturing perspective. From an observer's perspective, this layer or graphic appears behind the other layers or graphics. The interior effect design graphic 1740 includes translucent elements, but may also include opaque elements and / or a combination of opaque and translucent elements. The outer diameter of the interior effect design graphic 1740 is smaller than the outer diameter of the limbal design graphic 1700, while the inner diameters are substantially equal.

[0084] FIG. 17D illustrates a fourth exemplary embodiment of a cosmetic contact lens 1760 including all three layers or design graphics 1700, 1720, and 1740 printed in the order described above. It is important to note that the printing order differs from the other two exemplary embodiments described above because, like the previous exemplary embodiment, the inner and outer effect layers are switched. Additionally, all three design graphics have annular bands that create a unique limbal ring design pattern. While the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the visual effect is that they see the layers or design graphics in the reverse order described above. As shown, the overlapping layers include different colors, hues, levels of lightness and darkness, and patterns that create unique structures. Varying either the printing order or the color results in different designs. Variations in translucency can also be achieved.

[0085] The overall design created by the three layers comprises an annular structure with an inner diameter of about 6.4 to about 6.6 mm and an outer diameter ranging from about 12.70 to about 12.775 mm. This annular structure is similar in design to the iris structure of the eye. The open or negative space in the center of the lens corresponds to the pupil area or optical zone of the eye and is preferably clear so as not to interfere with vision. However, as noted above, this area may also be colored or may be the negative space between elements of the design.

[0086] Referring to FIG. 18A , a fifth exemplary embodiment of a limbal design graphic 1800 according to the present invention is shown. In this exemplary embodiment, the limbal design graphic 1800 includes a translucent annular band 1802 approximately 1.15 mm wide. Connected to the innermost boundary 1804 of the annular band 1802 and extending therefrom toward the geometric center of the limbal design graphic 1800 are a plurality of long, medium-length, and short ciliary structures 1806. Additional ciliary structures 1808 not connected to the translucent band 1802 are interspersed among the other ciliary structures 1806. The additional structures 1810 are free-form geometric shapes that may resemble circles, squares, triangles, and any combination thereof. These shapes may be adjacent or independent of each other and may cover and occupy the space between the ciliary structures 1806 and 1808. All of these structures are designed to resemble natural structures in the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The translucent annular band 1802 is designed to cover and highlight the wearer's limbal region, while the protruding structures 1806, 1808, and 1810 are designed to highlight the wearer's iris and blend the translucent annular band 1802 with the wearer's iris. The spaces between the ciliary structures create shapes, including colored shapes and features as well as exposed iris, depending on the overlapping and underlying elements. The center portion 1812 of the design graphic 1800 may be clear, as this portion of the design corresponds to the pupil. However, it is important to note that tint may also be used in this center portion. Additionally, tint may be used in the negative space between design elements.

[0087] In this exemplary embodiment, the overall limbal design graphic 1800 is a translucent black formed from black iron oxide pigment. In other embodiments, the limbal design graphic may include opaque elements and / or a combination of opaque and translucent elements. The limbal design graphic 1800 is printed using techniques described in more detail below, and it is printed first. In other words, it is the first graphic layer of the overall design that is incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0088] FIG. 18B illustrates a fifth exemplary embodiment of an interior effect design graphic 1820 according to the present invention. The interior effect graphic 1820 includes annular bands of non-interconnecting long, medium-length, and short dotted / dashed lines 1822 generally oriented toward the geometric center of the interior effect graphic 1820. The overall effect is designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. In this exemplary embodiment, the interior effect design graphic 1820 functions to provide subtle enhancements that retain translucency and / or color within a given area while alluding to guiding lines that may be found in the radial sulcus or ciliary zone of the natural iris. This subtle enhancement also functions to impart a small, pinpoint highlight. The interior effect design graphic 1820 is designed to cover and highlight the wearer's iris and at least partially overlaps the translucent annular band 1802 of the limbal design graphic 1800. Additionally, the interior effect design graphic 1820 covers the protruding structures 1806, 1808, and 1810 of the limbal design graphic 1800 in a manner that includes overlapping opaque segments, while also filling some or a portion of the negative space between the protruding structures 1806, 1808, and 1810. These overlapping segments are a different color and level of translucency than the individual's underlying structures. Additionally, the overlapping areas may be darker or lighter depending on the colors used for the underlying individual's structures. The spaces between elements of this pattern create shapes, including colored shapes and features and exposed irises, depending on the overlapping and underlying elements. The center portion 1824 of the design graphic 1820 may be transparent, as this portion of the design corresponds to the pupil. However, it is important to note that color tints may be used in this area as well as in the negative spaces between the design elements.

[0089] In this exemplary embodiment, the entire interior effect design graphic 1820 is a transparent orange formed from a composition including red iron oxide, transoxide yellow, yellow iron oxide, brown iron oxide, and transoxide pigment in ratios that produce a color in the orange family. The orange family includes yellow and gold. These colors or colors in this family are intended to accentuate the underlying natural iris color of individuals with brown or dark eyes. Different colors would be used for individuals with lighter eyes. In alternative embodiments, the interior effect design graphic 1820 may include opaque elements and / or a combination of opaque and translucent elements. This interior effect graphic 1820 is printed using techniques described in detail below and is printed second, after the limbal design graphic 1800. In other words, the interior effect graphic 1820 is printed after and on top of the limbal design graphic 1800. This printing order is from a manufacturing perspective. From the viewer's perspective, this layer appears behind the graphic 1800. The outer diameter of the inner effect design graphic 1820 is smaller than the outer diameter of the limbal design graphic 1800, but the inner diameters are substantially equal.

[0090] 18C illustrates a fifth exemplary embodiment of an external effect design graphic 1840 according to the present invention. In this exemplary embodiment, the external effect design graphic 1840 includes a translucent annular band 1842 having a width of approximately 1.44 mm. Connected to and extending from the innermost boundary 1844 of the translucent annular band 1842 are a plurality of long, medium-length, and short substantially triangular structures 1846. Some of the substantially triangular structures meet at their apexes, forming enclosed spaces 1848. The external effect design graphic 1840 also includes a plurality of lines 1850, not connected to the opaque annular band 1842, interspersed among the substantially triangular structures and oriented in the same direction, i.e., toward the geometric center of the external effect design graphic 1840. These structures are designed to resemble natural structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary body structures, etc. The outer edge of the annular band 1842 includes a comb-like structure 1852 that alters the appearance of the translucent annular band 1842 to a more ambiguous structure. The comb-like structure 1852 is intended to soften and blend the overlapping lines created by the overlapping translucent colors from the three layers. The outer effect design graphic 1840 is designed to cover and highlight the translucent annular band 1802 of the limbal design graphic 1800, as well as the entire inner effect design graphic 1820 and the protruding structures 1806, 1808, and 1810 of the limbal design graphic 1800. The outer layer design graphic 1840 fills in the more negative space, and the overlapping sections or positive space create additional hues, areas of different levels of opacity, and a distinct and distinct design separate from any single layer. Additionally, the negative space between the overlapping areas works in conjunction with the natural iris to create shapes and patterns that aid in blending and cosmetic effects. The negative space between elements of this design creates shapes, including colored shapes and features, as well as the exposed iris, depending on the overlapping and underlying elements. The center portion 1854 may be clear, as this portion of the lens corresponds to the pupil. However, it is important to note that tints may also be used.The comb-like structure 1852 varies the outer diameter of the translucent annular zone 1802 of the limbal design graphic by creating a shape that breaks up the rigid lines of the limbal design graphic 1800 .

[0091] In this exemplary embodiment, the entire outer effect design graphic 1840 is translucent brown, formed from a composition including red iron oxide, titanium dioxide, transoxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in proportions that create a family or color ranging from brown to black. In this exemplary embodiment, where the outer effect design graphic 1840 and the limbal design graphic 1800 overlap, they create darker, more defined / opaque areas, while the non-overlapping portions of the design remain more translucent, providing a blend from opaque to transparent. This technique allows for blending with the natural iris. The outer effect graphic 1840 is printed using techniques described in detail below, being printed third and on top of the inner effect graphic layer 1820. The printing order is from a manufacturing perspective. From the viewer's perspective, this layer appears behind the inner effect design graphic 1820. The outer diameter of the outer effect design graphic 1840 is smaller than the outer diameter of the limbal design graphic 1800, but the inner diameters are substantially equal.

[0092] FIG. 18D illustrates a fifth exemplary embodiment of a cosmetic contact lens 1860 including all three layers or design graphics 1800, 1820, and 1840 printed in the order described above. Again, the printing order returns to the limbal, inner effect, and outer effect graphics as in the first two exemplary embodiments. While the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the visual effect is that they see the layers or design graphics in the reverse order from that described in terms of printing. As shown, the overlapping layers include different colors, hues, lightness, darkness, and patterns that create unique structures. Variations in either the printing order or the colors, or both, result in different designs, as will be described in more detail below. Variations in translucency can also be achieved.

[0093] The overall design created by the three layers comprises an annular structure with an inner diameter ranging from about 6.7 mm to about 7.1 mm and an outer diameter ranging from about 12.675 mm to about 12.750 mm. This annular structure is similar in design to the iris structure of the eye. The open or negative space in the center of the lens corresponds to the pupil area or optical zone of the eye and is preferably clear so as not to interfere with vision. However, tint may be used in this area as well as in the negative spaces between the design elements.

[0094] The exemplary embodiments described above relate to contact lenses including multi-layer designs that may be used to enhance and / or accentuate the appearance of the eye in which the contact lens is positioned while maintaining a natural appearance. Each of these exemplary designs includes three layers: a unique limbal design graphic, a unique inner effect graphic, and a unique outer effect graphic. These layers may be formed using any number of design elements and principles. For example, lines may be used to define shapes and create contours that resemble or mimic the line structures, shapes, and contours found in the natural iris. Colors and tonal values ​​with different levels of translucency or opacity may be used to create blending and contrast, while different colors and tones may be used to suggest depth by creating highlights and shadows. Space may be used to determine composition; for example, positive space may be used to define and suggest effects, while negative space may be used to allow the natural iris to contribute to the overall pattern effect. Perspective of overlapping layers may be used to suggest and demonstrate depth within a given pattern. Texture may be used to create variations in the iris. As used in two-dimensional art, texture is created through the use of light and dark. Light and dark elements may be used to suggest depth and form.

[0095] As noted above, the present invention provides additional depth and variation in the overall pattern using three distinct layers. The limbal design graphic is the portion of the overall pattern that surrounds the outer diameter of the iris and is closest to the sclera and is intended to highlight, emphasize, and / or define the limbal region of the eye, but it also includes elements that extend into the iris. The inner effect graphic layer is the portion of the overall pattern that is intended to highlight the iris, but may also include portions that contribute to highlighting, highlighting, and / or defining the limbal region of the eye. The outer effect graphic layer is the portion of the overall pattern that is intended to highlight the iris, but may also include portions that contribute to highlighting, highlighting, and / or defining the limbal region of the eye. Using the multi-layer approach of the present invention, different levels of transparency and / or opacity can be created using overlapping and non-overlapping translucent layers.

[0096] While the exemplary embodiments described above illustrate various design features that may be used in cosmetic contact lenses, it is important to note that various combinations and subcombinations of elements / features may be used to create new designs. Varying the printing sequence can affect the overall design. Varying any single color in at least one layer can affect the overall design. Varying the design in any single layer can affect the overall design, and varying any of the design features in any single layer can affect the overall design. Varying the size of any design and / or the degree of overlap between layers can affect the overall design. Varying the amount of negative / positive space in any single layer or layers can affect the overall design. Varying the translucency of any or all of these layers can affect the overall design. Additionally, additional layers can also affect the overall design. The exemplary embodiments described above illustrate different designs that may be achieved using the various design elements described herein.

[0097] Although many terms are used throughout the specification, all designs described herein are intended to enhance the appearance of the wearer's eye. Accordingly, the term "enhance" as used herein is intended to include any act of setting off, highlighting, defining, delineating, improving, strengthening, amplifying, enlarging, intensifying and / or cosmetically altering the appearance of the wearer's eye.

[0098] It is important to note that all of the color formulations described herein and associated with the present invention are generally described in terms of pigment content and generally classified as specific colors. It is important to note that any suitable color may be used in practicing the present invention.

[0099] Designs / patterns / colors for different regions of the cosmetic contact lens are developed based on market research. These patterns are then etched into a metal structure, commonly referred to as a cliche. More specifically, a metal plate, preferably made of steel, more preferably stainless steel, is covered with a photoresist material that can become water-insoluble after curing. A pattern is selected or designed, then reduced to a desired size using any of a number of techniques, such as photography, and placed on the metal plate, and the photoresist material is cured. The metal plate or cliche is then washed with an aqueous solution, and the resulting image or pattern is etched into the plate to a suitable depth, e.g., about 20 microns. After the cliche is fabricated, a multi-step process is used to manufacture the cosmetic contact lens as follows:

[0100] FIG. 19 shows an overview of the pad printing process used in the manufacturing process. The first step 1902 of the process is filling the cliche depressions with the desired colorant. The cliche 1901 contains many cliche depressions 1903 with a specific pattern etched into them. The second step 1904 of the process involves removing excess ink or colorant from the surface of the cliche 1901. Excess ink is typically removed from the surface of the cliche 1901 using a doctor blade(s) on a cup 1905. The third step 1906 of the process is drying the colorant on the cliche 1901. The fourth step 1908 of the process is picking up the colorant in the cliche 1901 onto a pad. The fifth step 1910 of the process is drying the colorant or allowing it to dry on the pad. The sixth step 1912 of the process is transferring the colorant from the pad to the front curve surface for additional processing, as described below. In a seventh step 1914 of the process, the colorant is dried, or allowed to dry on the front curve of the front curve mold half. The process is then repeated for the remaining two effect layers.

[0101] FIG. 20 provides a more detailed process description. In the first step 2002, an unprinted front curve mold of a contact lens is provided. In the second step 2004, a clear base, i.e., one without pigment or dye, is applied to the front curve. The clear base depends on the lens material used, as described in more detail below. In the third step 2006, an ink containing a solvent, clear base, and pigment is applied to the clear base-printed front curve. This is repeated again, so that all three layers are applied to the clear base-printed base curve. In the fourth step 2008, a reactive monomer mixture, such as etafilcon-A, is then applied to the printed front curve. In the fifth step 2010 of the process, a back curve mold of a contact lens is positioned over the front curve mold and left there for two minutes while maintaining the temperature at 70° C. In the sixth step 2012 of the process, the reactive monomer mixture between the front and back curves is cured by exposure to visible light. The curing step uses 5 mW of visible light at a temperature of 70° C. for 4 minutes. In a seventh step 2014 of the process, the contact lenses from the molds are hydrated in a solution of 800 ppm Tween 80 and deionized water at 70° C. for 1 hour, followed by another hour in deionized water at 45° C. In an eighth step 2016 of the process, the contact lenses are steam sterilized in their own packaging saline solution at a temperature of 124° C. for 18 minutes. It is important to note that the process described above has been simplified for ease of explanation.

[0102] As noted above, the lens-forming material includes etafilcon A. Etafilcon A is a well-known proprietary material for producing contact lenses. Etafilcon A is a copolymer of 2-hydroxyethal methacrylate and methacrylic acid crosslinked with 1,1,1-trimetholpropane trimethacrylate and ethylene glycol dimethacrylate. Etafilcon A is used in many contact lenses available from VISTAKON®, a division of Johnson & Johnson Vision Care, Inc. While etafilcon A is used in the exemplary embodiments described herein, it is important to note that any suitable lens-forming material may be used. In the case of etafilcon A, the preferred binding polymer is a random block copolymer of HEMA and MAA or a homopolymer of HEMA. The weight percent of each component in these embodiments, based on the total weight of the binding polymer, is about 93 to about 100 weight percent HEMA and about 0 to about 2 weight percent MAA.

[0103] Using the process described above or a similar process, the pigments are encapsulated within the clear base and bulk material that forms the lens. In other words, all of the colored layers are encapsulated within the lens material and do not come into contact with the eye.

[0104] FIG. 21 illustrates the basic structure of a cosmetic contact lens formed from the process described above. One or more effect layers 2104 are sandwiched or encapsulated between a clear base 2102 and bulk lens material 2106. While only a single effect layer is shown, any number of effect layers or printed color layers may be encapsulated between the other two layers. As shown, the contact lens includes a complete clear base layer to encapsulate one or more color printed layers within the lens material, even if the one or more color printed layers have a substantially annular structure. Even with spokes, the colored design does not extend into the optic zone of the lens. In other words, in this design, the central optic zone or central visual area of ​​the contact lens is covered with clear base material. To maintain precise optical surfaces and paths and provide optimal patient vision, safety, and comfort, clear base material may be removed from the central visual area by utilizing a printing plate that prints an annular pattern to print a clear annular band on the front curve, as opposed to the complete coverage described above in step 2004. The transparent annular band can be sized to encapsulate or cover any design layer. More specifically, by appropriately sizing the printing plate, the openings in the annular structure can be optimized to maintain optical quality while ensuring encapsulation of the colored print layer. Since no design should intrude into the optical zone, there is no need to encapsulate anything in this area.

[0105] It is important to note that several terms may be used to describe the colored areas encapsulated as shown in the present invention. For example, the color layer may be referred to as an effect layer, a print layer, a design layer, and a color-print layer.

[0106] 22, 22A, and 22B illustrate an exemplary embodiment of a printing plate (cliche) 2200 that may be utilized in accordance with the present invention. In this exemplary embodiment, the printing plate 2200 is used to deposit a clear base material onto a front curve mold in a substantially annular pattern. The process described above for ink deposition is utilized in this exemplary embodiment with the base coat material first. In other words, the process described above with respect to FIGS. 19 and 20 is first used to deposit the clear base coat material onto the front curve mold. The deposition location is one that allows for the encapsulation of pigments containing any suitable design while leaving the central visual zone (i.e., the area corresponding to the pupil area of ​​the eye) free of any clear base coat material. The modified clear base printing plate 2200 covers any colored design while eliminating the presence of clear base coat material in the optical zone, or covers all remaining portions of the anterior surface of the contact lens while eliminating the presence of clear base coat material. In other words, the clear base may extend beyond the design to the edge of the lens. The printing plate 2200 comprises a first annular section 2202, a transition section 2206, and an optical area opening 2204. The first annular section 2202 may extend from a location corresponding to the edge of a contact lens, or from an optional point inset from the edge of the lens corresponding to a location adjacent to the colored design, to the transition section 2206. According to an exemplary embodiment of the invention, the first annular section 2202 has an inner diameter of approximately 3.9 mm and an outer diameter of approximately 17 mm. In a preferred embodiment, the first annular section 2202 has an inner diameter of approximately 6 mm and an outer diameter of approximately 13.5 mm. The first annular section 2202 is the portion of the printing plate 2200 that picks up the clear base material for transfer to the pad. The transition section 2206 is a much smaller annular band that extends from the inner diameter of the first annular section 2202 to the outer diameter of the optical area opening 2204. According to an exemplary embodiment of the present invention, transition section 2206 has an inner diameter of about 1.9 mm and an outer diameter of about 8 mm. In a preferred embodiment, transition section 2206 has an inner diameter of about 4.4 mm and an outer diameter of about 6 mm. Transition section 2206 is configured to retain a decreasing amount of clear basecoat material as it approaches vision area opening 2204, which may be accomplished in a number of different ways, as described in detail herein.As shown, the transition section 2206 comprises a dithering pattern or matrix that picks up a certain amount of base coat material for deposition onto the front curve mold. The transition section or zone 2206 is utilized to better fuse or integrate the two materials together. More specifically, the transition section 2206, having a transferred pattern / matrix and a reduced amount of base coat material, provides better fusion / integration of the clear base coat material and lens monomer, thereby reducing any induced stresses that may occur in the absence of the transition section 2206. In an exemplary embodiment, the transition section 2206 has a thickness of approximately 30 microns proximate the first annular section 2202 and approximately 0 microns proximate the optic area opening 2204. In a preferred embodiment, the transition section 2206 has a thickness of approximately 20 microns proximate the first annular section 2202 and approximately 10 microns proximate the optic area opening 2204. However, after pad printing, a reactive monomer mixture is dispensed onto the printed front curve and the back curve mold is placed over the front curve mold to form a lens as detailed above without any change in lens thickness.

[0107] It is important to note that any suitable process or technique can be utilized to encapsulate the tinted design, and not just the lens monomer, as long as the basecoat material is not deposited in the central optical zone. Additionally, it is important to note that the dimensions of the clear basecoat material transferred from printing plate 2200 are based on factors such as pad shape and hardness, and ultimately, lens expansion and measurement techniques.

[0108] The exemplary transition section 2206 described above comprises both a pattern / matrix, as illustrated in detail in the exploded view of FIG. 22A , and a thickness gradient, as illustrated in detail in the exploded cross-sectional view of FIG. 22B . However, other exemplary transition sections may comprise either one or the other rather than the combination shown above. In particular, in an alternative exemplary embodiment, the transition section may comprise only a pattern / matrix, where a reduction in pattern density serves to reduce the thickness of the material, thereby resulting in a reduction in potential induced stresses. In another alternative exemplary embodiment, a reduced amount of solid material is utilized, thereby resulting in a reduction in potential induced stresses. The pattern / matrix, whether utilized alone or in combination with a thickness gradient profile, may comprise any suitable pattern. For example, the pattern may include any suitable geometric design, dithering design, dot matrix design, or any random design. The design illustrated in FIGS. 22 and 22A is a basic design with decreasing density features from the first annular section 2202 toward the viewing area opening 2204.

[0109] FIG. 23 illustrates the basic structure of a cosmetic contact lens formed from the above-described process in accordance with the present invention. One or more effect layers and / or colored print layers 2304 are sandwiched or encapsulated between an annular clear base 2302 and bulk lens material 2306. As previously mentioned, while only a single effect layer is illustrated, any number of effect layers may be encapsulated between the other two layers. As illustrated, the contact lens includes an annular-shaped clear base material layer 2302 that encapsulates one or more colored print layers within the bulk lens material, i.e., reactive monomer mixture. In other words, with this design, the central optic zone or central visual area 2308 of the contact lens is not coated, thereby maintaining a precise optical surface and path while ensuring complete coverage / encapsulation of the colored layer 2304 and maintaining a high level of comfort. The design of the printing plate 2200 with the transition section 2206 creates a transition region 2310 within the annular clear base layer 2302, which provides better blending / integration between the materials as described in detail above. According to an exemplary embodiment of the invention, opening 2308 has a diameter ranging from about 1.9 mm to about 8.8 mm, and in a preferred embodiment has a diameter of about 5.75 mm.

[0110] In an alternative exemplary embodiment, cosmetic or non-cosmetic contact lenses are coated on either the anterior surface, posterior surface, or both surfaces for reasons other than pigment encapsulation, e.g., a smooth coating for comfort, and it may be desirable to utilize the annular transitional structure disclosed herein to better blend / integrate the materials while maintaining high optical quality. More specifically, when a contact lens is formed from a first material and then a second material is added to one or both surfaces to increase the smoothness of the lens, the blending of the two materials can induce the stresses described above. The solution would again be the annular transitional coating / structure shown above to reduce any potentially induced stresses.

[0111] According to another exemplary embodiment, pearlescent pigments may be incorporated into one or more regions or portions of a cosmetic contact lens to impart a lustrous, sparkling, iridescent appearance thereto. For example, these pearlescent pigments may be applied to at least a portion of the lens that corresponds to the wearer's sclera. The pearlescent and interference effects are provided by alternating layers of transparent materials with different refractive indices. Pearlescent pigments may be combined with other pearlescent pigments and / or with different types of pigments (e.g., iron oxide, phthalocyanine, and titanium dioxide, or dyes). Some of the resulting colors may be silver, gold, and various shades of red, blue, and green.

[0112] Generally, titanium dioxide is the currently preferred pigment used to create light-colored scleral regions on cosmetic contact lenses. Cosmetic contact lenses according to one exemplary embodiment of the present invention incorporate a pearlescent pigment in the region corresponding to the wearer's sclera, thereby creating a lustrous, iridescent appearance. In other words, the combination or incorporation of pearlescent pigments, for example, a mica-based pearlescent pigment coated with titanium dioxide, results in a brighter, whiter scleral region with a wet, reflective appearance that is also visually natural. A preferred pearlescent pigment is a silver-type mica-based pigment coated with titanium dioxide. An exemplary mica-based pigment is potassium aluminum silicate, which may be coated with titanium dioxide (TiO2) or iron oxide (Fe2O3). EMD Chemicals Inc. sells a U.S. Food and Drug Administration-approved combination of natural silicate with titanium dioxide under the trademark Candurin®. However, it is important to note that any pearlescent pigment may be combined with other pearlescent pigments and / or different types of pigments or dyes for use in the scleral region.

[0113] The cosmetic contact lenses of the present invention incorporating pearlescent pigments may include a limbal ring, a pattern covering the wearer's iris, a pattern covering the pupil region, a clear pupil region, a light-colored sclera region, a light-colored sclera region with a geometric pattern, and / or any combination thereof. The limbal ring is preferably opaque or translucent. The iris region may be translucent, opaque, or transparent. The pupil region may be clear or contain no pattern at all. Both pigments and dyes may be used to color the pattern elements of the limbal, iris, and pupil regions of the contact lens. Any organic pigment, inorganic pigment, effect pigment, dye, or any combination thereof may be used to color the pattern elements.

[0114] Referring now to FIG. 24, there is shown a schematic diagram of a cosmetic contact lens 2400 with a light-colored scleral region 2402 formed from a mixture containing pearlescent pigment in accordance with the present invention. The light-colored scleral region 2402 with pearlescent pigment may be manufactured as follows: A clear base ink is prepared by adding 35.35 grams of 1-propanol to 588.11 grams of 1D Clear Base. A more detailed description of the clear base ink composition and its preparation is provided below. The ink sample was then mixed on a Servodyne mixer for three (3) minutes at 1800 rpm. A twenty (20) percent Silver Fine ink was prepared by adding 5.98 grams of 1-propanol to 20.05 grams of Silver Fine pigment (EMD Chemicals, Candurian® Pearl Effect Colors) and 80.01 grams of 1D Clear Base. The mixture was then mixed by hand. A steel printing plate with an etched pattern was filled with the ink mixture and printed onto the surface of the mold. This was previously described. The ink was transferred from the printing plate to the surface of the mold using a silicone pad. The clear base ink was printed first, followed by the Silver Fine ink. The lens-forming material (i.e., etafilcon A reactive monomer mixture) was deposited onto the printed mold, after which the mold assembly was completed with complementary mold halves. The lens material was then cured, removed from the mold, and equilibrated in a buffered saline solution, all as described in detail above. The pearlescent pigment is encapsulated within the lens material.

[0115] A binder polymer for the clear base ink was formed using 96 grams of 1-dodecanethiol (DODT), 56.54 grams of lauryl methacrylate (LMA), 7.40 grams of methacrylic acid (MAA), 1367 grams of hydroxyethyl methacrylate (HEMA), 68.5 grams of glycerol, 378 grams of 1-ethoxy-2-propanol (EP), 1511 grams of isopropyl lactate (IPL), and 8.89 grams of 2,2'-azobis(2-methylbutyronitrile) (AMBN). DODT was added first, and the monomers and solvent (except for approximately 50-100 cc of IPL) were mixed in a five (5) liter blue-cap bottle and stirred for ten (10) minutes. The mixture was then poured into a five (5) liter stainless steel reactor using a stirrer and nitrogen. The mixture was stirred and heated for approximately twenty-five (25) minutes until the temperature reached sixty-eight (68) degrees Celsius. After stabilizing the temperature at 68 (68)°C, AMBN was dissolved in the remaining IPL and added with the nitrogen bleed open. The polymerization was allowed to proceed for 16-24 hours, after which the temperature was increased to 80 (80)°C to terminate the reaction. The mixture was then allowed to equilibrate to room temperature. The viscosity of the mixture was adjusted as desired by mixing four (4) parts IPL with one (1) part EP.

[0116] As mentioned above, lens-forming materials include etafilcon A. Etafilcon A is a well-known proprietary material for producing contact lenses. Etafilcon A is a copolymer of 2-hydroxyethal methacrylate and methacrylic acid crosslinked with 1,1,1-trimetholpropane trimethacrylate and ethylene glycol dimethacrylate. Etafilcon A is used in many contact lenses available from Johnson & Johnson Vision Care, Inc. Although etafilcon A is used in the exemplary embodiments described herein, it is important to note that any suitable lens-forming material may be used.

[0117] According to another exemplary embodiment, the present invention relates to cosmetic contact lenses that include one or more effect layers covering one or more regions of the eye in which they are located, a pearlescent pigment incorporated within portions of the contact lens covering various regions of the eye (e.g., the sclera, the iris, or both the sclera and iris, as described above), and a clear coating encapsulating the one or more effect layers and the pearlescent pigment. Preferably, the clear coating has a ring shape, as described above, so that the central optical portion of the lens is of the highest optical quality. According to another exemplary embodiment, the pearlescent pigment may be incorporated in a section covering the sclera, iris, and limbal ring, in the sclera and limbal ring, in the limbal ring and iris, in the sclera alone, in the iris alone, or in the limbal ring alone. Additionally, in exemplary embodiments, the limbal ring may have the following characteristics and may include the pearlescent pigment, while other exemplary embodiments may not use a limbal ring.

[0118] It is important to note that any section of contact lenses may contain the ink compositions / dyes / pigments for forming effect layers as described herein, as well as the coated mica-based pearlescent pigments as described herein, either alone or in combination with each other. For example, a pigment-formed effect layer may be combined with a mica-based pearlescent pigment, a pigment-plus-mica-based pearlescent pigment effect layer may be combined with a mica-based pearlescent pigment, a pigment-plus-mica-based pearlescent pigment effect layer may be combined with a pigment-plus-mica-based pearlescent pigment effect layer, and a mica-based pearlescent pigment-based effect layer may be combined with a mica-based pearlescent pigment-based effect layer in any section including contact lenses. In addition, mica may be used alone to form effect layers, or it may be used as an opacifier or as a primary additive in forming coloring compositions. For example, mica may be used to create a more vibrant yellow color.

[0119] More specifically, mica-based pearlescent pigments may be used as an opacifier in forming the limbal ring, or may be used as a primary component in forming the limbal ring itself. In one exemplary embodiment, mica-based pearlescent pigments may be added to the limbal ring effect to add vibrancy and sparkle to the limbal ring, as illustrated in FIG. 25. In FIG. 25, a first exemplary embodiment of a limbal ring-tapered spoke pattern on a contact lens 2500 is shown. In this exemplary embodiment, the limbal ring 2502 is a black, opaque band approximately 1 mm wide. Beginning at the innermost boundary 2504 of the limbal ring 2502 and extending inward toward the geometric center of the contact lens 2500 are a plurality of randomly arranged tapered spokes 2506, whose innermost boundary 2512 forms a circle with a diameter of 7 mm measured from the geometric center of the contact lens 2500. All of the spokes 2506 are generally similarly configured, although preferably no spoke 2506 is identical to another spoke 2506. The spokes 2506 are interspersed or bounded by spaces 2508, which have no elements within them. The spaces 2508 are also generally all similarly configured, although preferably no one of the spaces 2508 is identically configured to any of the spaces 2508 or any of the other spokes 2506. Regions 2510 are regions without pattern elements, and the regions shown partially constitute the iris portion of the wearer's eye, as well as the entire pupil portion of the wearer's eye, or the portion of the lens that covers the wearer's pupil when the lens is centered on the eye. As shown, regions 2510 are transparent, but may also be translucently or opaquely colored. The innermost boundary 2504 shown is uniform and regularly shaped, but may also be a non-uniform, irregular boundary. Similarly, the boundary 2512 of the tapered spokes forms a substantially uniform boundary, but may also form a non-uniform boundary. Mica-based pearlescent pigment 2514 is encapsulated within the limbal ring region 2502 and may be in a random or non-random pattern. It is important to note that mica-based pearlescent pigment may be incorporated into any of the designs shown herein.

[0120] Mica-based pearlescent pigments may be used in forming the section covering the iris region. For example, mica-based pearlescent pigments may be used to form an effect layer. A different coating may be used on the mica. Mica-based pearlescent pigments may be added to an existing effect layer. Mica-based pearlescent pigments may be added as an opacifier in an existing effect layer. Additionally, mica-based pigments may be used to develop new colors.

[0121] Referring now to FIG. 26 , an exemplary effect design graphic 2600 for a cosmetic contact lens covering the iris region of a wearer's eye is illustrated. As can be seen from FIG. 26 , this design graphic does not include a limbal ring, as do most of the other designs, creating an entirely different effect. Additionally, unlike the other designs, this exemplary embodiment includes only mica-based pearlescent pigment 2602 that makes up the design. The mica-based pearlescent pigment 2602 is disposed within the iris region and may be in a random or non-random pattern. Additionally, as described herein, the mica-based pearlescent pigment may be coated with various other materials to change its color or add additional effects. In other exemplary embodiments, the effect layer (such as the illustrated one) may include a combination of standard pigments, such as those described above, with the pearlescent pigment. It is important to note that while FIG. 26 illustrates the regular shape of the pigment, any other shape other than a ring may be envisioned.

[0122] Mica-based pearlescent pigments may be used in forming sections that cover the scleral region. For example, mica-based pearlescent pigments may be used to form effect layers within the sclera. Different coatings may be used on the mica. Mica-based pearlescent pigments may be added to effect layers present in the sclera region, e.g., as lightening colors. Mica-based pearlescent pigments may be added as opacifiers within the sclera region. Additionally, mica-based pigments may be used to develop new colors for use in the sclera region. The degree and amount of mica-based pearlescent pigment added to one or more sections or regions of a contact lens may be adjusted depending on the desired range of effects, from subtle to noticeable.

[0123] Reversible contact lens design According to yet another exemplary embodiment, cosmetic contact lenses may be made reversible, thereby providing multiple effects. In other words, a single contact lens may provide two different eye-enhancing effects by simply removing it from the eye, inverting it, and then replacing it. In this way, contact lens wearers can have a choice of cosmetic effects using a single lens, rather than having to purchase two lenses for different effects. Individuals may want to change their appearance throughout the day. For example, they may prefer a more subtle effect when working and a more dynamic effect for post-work or non-work activities. With this type of reversible lens, any type of effect can be utilized, from a color change from inverted to nacreous pigment to no inverted nacreous pigment.

[0124] The reversible cosmetic contact lenses of the present invention are designed to provide an interchangeable cosmetic appearance to the eye. This effect may include variations in one or more of color, pattern, or effect. The resulting interchangeable cosmetic appearance may be customized based on print sequence, design / pattern, color, pattern placement, opacity level, etc. Therefore, the following describes a reversible soft contact lens. This lens provides the same corrective power and comfort regardless of how it is worn.

[0125] Soft contact lenses may be designed with base curve(s) configured to fit the lens to the corneal / scleral profile of the wearer's eye, a diameter generally larger than the corneal diameter, and anterior curve(s) that provide the refractive function of the lens. Because soft contact lenses, by design, can be made from soft materials, they can conform to the corneal / scleral profile and "wrap" onto the eye. See FIG. 27A. This wrap or deformation of the lens from its inverted state can have a significant refractive effect on the eye as the contact lens curve changes to accommodate the corneal and scleral profile. When the lens is inverted, the anterior surface becomes the posterior surface that touches the ocular surface when the inverted lens wraps around the eye. See FIG. 27B. Furthermore, the effect of wrap on the refractive power of the lens may also depend on whether the lens is applied to the eye in a base orientation or an inverted / inside-out orientation.

[0126] According to the present invention, the behavior of a lens in various orientations can be modeled (e.g., using finite element analysis (FEA), MSC Marc software, etc.) to simulate lens inversion, lens wrapping on the eye, and lens handling, e.g., placement of the lens on the eye using fingers or tools. For example, FIGS. 28A-28B show distortion modeling of a conventional soft contact lens in a base orientation (FIG. 28A) where no distortion is assumed, and in an inverted or inside-out orientation (FIG. 28B) with residual distortion after forcibly deflecting the lens. When a lens using a standard design is inverted, the peripheral thickness becomes a resistance to deformation, resulting in residual distortion of the lens in the inverted configuration. This corresponds to the lens edges flaring out, thus increasing the diameter (reducing sag), and ultimately resulting in different on-eye fitting characteristics when placed on the eye. In fact, according to current practice by soft contact lens wearers, the greater the dissimilarity between the base and inverted configurations, the easier it is to recognize by visual inspection whether the lens is inverted or not. 29A-29B illustrate distortion modeling of a soft contact lens according to the present invention (e.g., with reduced peripheral thickness), the lens in a home orientation (FIG. 29A) and an inverted or inside-out orientation (FIG. 29B). By managing (e.g., reducing, minimizing, etc.) the peripheral thickness, the primary resistance to lens inversion is reduced, and thus the lens diameter and sag are closer to their originally intended values ​​in the home configuration (before inversion), i.e., the deviation in diameter or sag (dDiam or dSag) between the home and inside-out orientations is minimized.

[0127] A potential disadvantage of reducing peripheral thickness is increased difficulty in handling the lens (e.g., flimsiness and folding). Several design alternatives were generated by the present invention and manufactured for evaluation. In one embodiment, a survey of 14 subjects was conducted based on two metrics / questions: 1) assessing the ease of determining that the lens is inside-out, and 2) assessing the ease of handling the lens for each of five sample lenses. The five lenses included one control lens and four test lenses of various variations of the proposed design, each with a predetermined diameter (D), base curve (BC), and center thickness (CT) in millimeters (mm), as follows: Control: D14.2, BC8.5, CT0.085 Design 403: D14.3, BC8.1, CT0.1 Design 404: D14.3, BC8.1, CT0.2 Design 405: D14.3, BC8.3, CT0.1 Design 406: D14.3, BC8.5, CT0.1

[0128] Figure 30 shows a list of the survey ratings of the 14 subjects, with each rating as follows: 1=Very difficult 2=Somewhat difficult 3=Somewhat easy 4=Very easy

[0129] [Table 1]

[0130] According to Table 1 and subjective feedback, design 405 appears to perform optimally in both respects: easy to handle and at the same time more difficult to identify as inside-out. Figure 31 shows a plot depicting the relationship between simulated dSag (deviation in sag after inversion) and survey scores regarding the ease of identifying whether a lens is inside-out. This plot shows that simulated dSag can be used as a predictor of the inversion discrimination score.

[0131] To further explore the range of applicable design parameters, design 405 was selected as the optimal design, and variation ranges for diameter, base curve, and center thickness were proposed for further evaluation, as shown in Table 2.

[0132] [Table 2]

[0133] Within the parameter ranges above (represented by Table 2), in addition to the original 18 (18) designs, an additional 27 (27) design combinations were generated and evaluated for inversion simulations, resulting in a total of 45 design variations. Figure 32 shows a plot illustrating the resulting design space of diameter, base curve, and CT, and their effect on the simulation metric dSag as a function of marker size (e.g., diameter of a circular marker). The smaller the dSag, the more difficult it is to determine inversion and the better the performance.

[0134] Based on the data in Table 1 and the relationship between the simulation metric dSag and the ease of inside-out discrimination (FIG. 31), the limit values ​​of the preferred dSag and the acceptable dSag can be estimated as follows: Ease of identifying inside-out: <1.2% is preferable <==> dSag <1% is preferable Ease of detecting inside-out: <2% is acceptable <==> dSag <1.3% is acceptable

[0135] The terms "preferred" and "acceptable" are used herein to distinguish exemplary performance levels and are not intended to indicate a preferred or best embodiment. Other performance ranges may be used. These limits on the simulation metric dSag allow us to identify preferred designs (Table 3) and acceptable designs (Table 4) from the 45 designs that fall within the ranges shown in Table 2, as follows:

[0136] [Table 3]

[0137] [Table 4]

[0138] Material properties (e.g., modulus of elasticity measured using ANSI Z80.20) can affect the mechanical behavior of the lens. To study the effect of material properties, modulus of elasticity was varied between 150 kPa and 660 kPa. To evaluate metrics for handling and inside-out (I / O) discrimination, inversion and handling simulations were repeated, and the results are shown in Table 5.

[0139] [Table 5]

[0140] The data in Table 5 indicate that increasing the modulus can improve the handling of reversible lenses without affecting the inverted shape of the lens, which is a desirable result.

[0141] In contact lenses, the peripheral edge of the lens can affect overall comfort. For example, Figure 33 shows a model of the peripheral edge of a conventional contact lens wrapped in a home orientation. As shown, the edge wraps in a manner that is typically comfortable for the wearer when the lens edge is in full contact with the eye. For comparison, Figure 34 shows a model of the peripheral edge of a conventional contact lens wrapped in an inverted, or inside-out, orientation. As shown, the peripheral edge wraps differently from the wearer's eye, with a gap between the edge apex and the surface of the eye, which can be uncomfortable for the wearer as the eyelid repeatedly moves from the surface of the eye to the contact lens during blinking.

[0142] However, according to the present invention, by using an edge profile that is symmetrical or substantially similar on both sides of the lens, the difference in ocular comfort between the two orientations can be minimized. Additionally or alternatively, the existing gap between the edge apex and the ocular surface (i.e., apex height) can be reduced in either orientation. For example, Figure 35 shows a model of the peripheral edge of a contact lens according to the present disclosure wrapped in a base orientation. For comparison, Figure 36 shows a model of the peripheral edge of a contact lens according to the present disclosure wrapped in an inverted or inside-out orientation.

[0143] As an ophthalmic medical device that provides vision correction, an invertible soft contact lens should provide equivalent power correction using either orientation. Given the incompressible nature of soft contact lens material and the fact that the lens wraps around the eye when placed on either side, it can be assumed that the optic zone of the contact lens will deform to a similar curvature or shape on the eye when placed in either orientation. Using lens designs according to the present disclosure, preliminary opto-mechanical simulations are performed in both the home and inverted orientations. The analysis is repeated for designs using different powers (-4.00D, 0.00D, +4.00D). Optical analysis is performed assuming both unwrapped and wrapped lens shapes (estimated by FEA). Figures 37A-37D show plots based on the optical analysis of a 0.00D lens in both the home and inverted or inside-out orientations. The plots shown in Figures 37A-37D compare the lens profiles with their calculated power profiles. These show minimal differences in lens power (within the optical zone r<4 mm) between the base and inside-out orientations (Figures 37A-B). Notably, once the lens is wrapped around the eye, the differences between the power profiles disappear as the geometries become equivalent (Figures 37C-D).

[0144] Figures 38A-38D show plots based on optical analysis of -4.00D lenses in both the base and inverted or inside-out orientations. These plots compare the lens profiles with their calculated power profiles. They show minimal differences between the two sides (Figures 38A-38B). Notably, once the lenses are wrapped around the eye, the differences between the power profiles disappear as the geometries become equivalent (Figures 38C-38D).

[0145] Figures 39A-39D show plots based on optical analysis of +4.00D lenses in both the base and inverted or inside-out orientations. These plots compare the lens profiles with their calculated power profiles. They show minimal differences between the two sides (Figures 39A-39B). Notably, once the lenses are wrapped around the eye, the differences between the power profiles disappear as the geometries become equivalent (Figures 39C-39D).

[0146] These opto-mechanical simulations support the concept that visual acuity with invertible lens designs according to the present disclosure can be independent of lens orientation.

[0147] As described herein, the peripheral region of the lens can be designed to minimize the disparity in base curve and diameter between the base and inside-out orientations. The effect of peripheral thickness on this disparity depends on the lens diameter, base curve, and central thickness, which must be optimized along with the peripheral thickness to achieve best performance. If the base curve and diameter of the lens are comparable between the base and inside-out orientations, then the on-eye fit and visual performance are expected to be comparable as well.

[0148] Examples of reversible cosmetic contact lenses As shown in Figures 19 and 20, the reversible cosmetic contact lenses of the present invention are produced by pad printing using a transparent annular clear base, followed by several effect layers for color and graphic patterns, including an optional barrier layer that may be continuous, intermittent, or any combination thereof, to limit the effect to either the non-inverted or inverted orientation. The efficiency of the barrier layer depends on its position and opacity and may completely or partially eliminate the effect in one orientation or another. The pad printing process may further include an additional annular clear base layer between the effect layers to provide spacing or depth to the overall graphic design. The front curve mold and base curve mold used in the above pad printing process are designed such that one or more of the diameter, base curve, peripheral thickness, or center thickness are configured to provide a dSag of less than 1.3% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. Alternatively, the front curve mold and base curve mold used in the pad printing process described above are designed with one or more of a diameter, base curve, or thickness profile configured such that when the lens is in an inverted orientation with at least a portion of the second surface abutting the wearer's eye, the apex height, measured from the edge apex to the surface nearest the eye, is 0.020 millimeters or less.

[0149] As shown in Figure 40, the reversible cosmetic contact lenses of the present invention show one graphic design in a non-inverted orientation (side A) and another cosmetic design in an inverted orientation (side B). Side A depicts a dark pattern with a lighter inner highlight, while side B depicts a lighter pattern with a more pronounced limbal ring. The exact color and level of opacity and iridescence may vary between these cosmetic designs.

[0150] Colorants used in pad printing inks can be uncoated or coated pigments and include metal oxide pigments such as iron oxide, chromium oxide, and titanium dioxide; organic dyes such as phthalocyanine blue, phthalocyanine green, and carbazole violet; and pearlescent and interference pigments such as cholesteric liquid crystals, muscovite, synthetic fluorphlogopite, and borosilicate. The effect layer may vary in opacity or translucency depending on the ink density and overlay level. A barrier layer is optional but is typically opaque to prevent the underlying color from showing through. Typically, the barrier layer is a light color to provide a clean background for another graphic design, for example, by pad printing a titanium dioxide layer.

[0151] Although the reversible cosmetic contact lenses of the present invention are not limited by the number or arrangement of effect layers in the pad printing process, there are several preferred layer combinations as described below: The non-inverted and inverted cosmetic designs are the sum of all effect layers, barrier layers, and clear base layers within the reversible cosmetic contact lens.

[0152] First, reversible cosmetic contact lenses are manufactured using a mold assembly configured so that the dSag is less than 1.3% between the non-inverted and inverted lens orientations, or the apex height, measured from the limbal apex to the surface nearest the eye, is 0.020 millimeters or less in the inverted orientation, by the following pad printing sequence: (1) print a clear base layer on the inner surface of the front curve mold; then (2) print iris-enhancing cosmetic designs on top of each other using an inner effect design graphic and an outer effect design graphic, such that at least one cosmetic design is opaque. In this manner, other cosmetic designs may be translucent. The cosmetic designs may also include the same or different limbal design graphics. Selected designs are printed so that they at least partially overlap each other when viewed while wearing the lens. The designs can be cosmetically identical, nearly identical, or substantially different in shape, color, and combinations thereof. Examples of interior and exterior effect design graphics are shown in Figures 14B, 14C, 15B, 15C, 16B, 16C, 17B, 17C, 18B, and 18C. Examples of limbal design graphics are shown in Figures 14A, 15A, 16A, 17A, and 18A. Examples of cosmetic designs are shown in Figures 14D, 15D, 16D, 17D, and 18D.

[0153] Second, reversible cosmetic contact lenses are manufactured using a mold assembly configured to achieve a dSag of less than 1.3% between the non-inverted and inverted lens orientations, or a vertex height of 0.020 millimeters or less in the inverted orientation, measured from the limbal apex to the surface nearest the eye, using the following pad-printing sequence: (1) print a clear base layer on the inner surface of the front curve mold, and then (2) print two iris-enhancing cosmetic designs on top of each other using an inner effect design graphic and an outer effect design graphic, with some overlap and with a barrier layer in between. In this manner, both cosmetic designs may be translucent. The translucency may vary between the cosmetic designs. Alternatively, the barrier layer may be partially opaque, forming a common limbal design graphic. The two cosmetic designs may also include the same or different limbal design graphics. The selected cosmetic or barrier layer designs are printed so that they at least partially overlap each other when viewed in wear. The cosmetic and barrier designs can be cosmetically identical, nearly identical, or substantially different in shape, color, and combinations thereof. Examples of interior and exterior effect design graphics are shown in Figures 14B, 14C, 15B, 15C, 16B, 16C, 17B, 17C, 18B, and 18C. Examples of limbal design graphics are shown in Figures 14A, 15A, 16A, 17A, and 18A. Examples of cosmetic designs are shown in Figures 14D, 15D, 16D, 17D, and 18D.

[0154] Third, reversible cosmetic contact lenses are manufactured using a mold assembly configured to achieve a dSag of less than 1.3% between the non-inverted and inverted lens orientations, or a vertex height measured from the limbal apex to the surface nearest the eye of 0.020 millimeters or less in the inverted orientation, by the following pad-printing sequence: (1) printing a clear base layer on the inner surface of the front curve mold; and (2) printing two iris-enhancing cosmetic designs using inner and outer effect design graphics, such that the inner and outer effect design graphics create a blending layer between the two iris-enhancing cosmetic designs. The limbal ring may be translucent or opaque. In this manner, the blending layer is visible in both the non-inverted and inverted orientations. Alternatively, only one iris-enhancing cosmetic design includes a blending layer, and the two cosmetic designs are separated by a barrier layer. Furthermore, either one or both cosmetic designs may include a limbal design graphic. Examples of interior and exterior effect design graphics are shown in Figures 14B, 14C, 15B, 15C, 16B, 16C, 17B, 17C, 18B, and 18C. Examples of limbal design graphics are shown in Figures 14A, 15A, 16A, 17A, and 18A. Examples of cosmetic designs are shown in Figures 14D, 15D, 16D, 17D, and 18D.

[0155] Fourth, reversible cosmetic contact lenses are manufactured using a mold assembly configured so that the dSag is less than 1.3% between the non-inverted and inverted lens orientations, or the apex height, measured from the edge apex to the surface nearest the eye, is 0.020 millimeters or less in the inverted orientation, by the following pad printing sequence: printing any of the preferred layering combinations described above with an additional clear base layer between any or all effect layers, thereby adding a three-dimensional or depth feature to the cosmetic design.

[0156] While what has been shown and described is considered to be the most practical and preferred embodiment, it will be apparent that variations from the specific designs and methods described and illustrated will themselves be obvious to those skilled in the art and may be used without departing from the spirit and scope of the invention. The present invention is not limited to the particular constructions described and exemplified, but should be constructed to be consistent with all modifications that may fall within the scope of the appended claims.

[0157] The following abbreviations are used throughout the examples and have the following meanings: TL03 Lighting: Philips TLK 40W / 03 bulb or TLK 20W / 03 bulb. LED: Light-emitting diode BC: Base curve plastic mold FC: Front curve plastic molding mold PS: A homopolymer of styrene, used as a plastic mold resin or part, and may contain additives. PP: Polypropylene is a homopolymer of propylene and is used as a plastic mold resin or part, and may contain additives. TT: Tuftec, a hydrogenated styrene butadiene block copolymer (Asahi Kasei Chemicals) used as a plastic mold resin or part, which may contain additives. Z: Polycycloolefin thermoplastic polymer (Zeon Corporation), used as a plastic mold resin or part, and may contain additives. RMM: reactive monomer mixture HEMA: 2-hydroxyethyl methacrylate (Bimax) MAA: methacrylic acid (Acros) EGDMA: Ethylene glycol dimethacrylate (Esstech) TMPTMA: Trimethylolpropane trimethacrylate (Esstech) Omnirad 1700: a mixture of bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphine oxide and 2-hydroxy-2-methyl-1-phenyl-propan-1-one AIBN: Azobisisobutyronitrile (initiator) DODT: 1-dodecanethiol (chain transfer agent) mPDMS: mono-n-butyl terminated, monomethacryloxypropyl terminated polydimethylsiloxane (M n =800~1500 Daltons) (Gelest) Norbloc: 2-(2'-hydroxy-5-methacrylyloxyethylphenyl)-2H-benzotriazole (Janssen) Blue HEMA: 1-amino-4-[3-(4-(2-methacryloyloxy-ethoxy)-6-chlorotriazin-2-ylamino)-4-sulfophenylamino]anthraquinone-2-sulfonic acid (described in U.S. Pat. No. 5,944,853) DIW: Deionized water Tween 80: Polysorbate 80 or polyoxyethylene 20 sorbitan monooleate (Croda) PPM: Weight parts per million IPA: Isopropyl alcohol 1E2P: 1-ethoxy-2-propanol IPL: Isopropyl lactate Filling solution: 0.84 wt% sodium chloride, 0.91 wt% boric acid, 0.24 wt% sodium borate decahydrate, 0.01 wt% disodium ethylenediaminetetraacetic acid, and 98 wt% deionized water. BAGE: boric acid glycerol ester (the molar ratio of boric acid to glycerol was 1:2), 299.3 grams (mol) of glycerol and 99.8 grams (mol) of boric acid were dissolved in 1247.4 grams of 5% (wt / wt) aqueous EDTA solution in a suitable reactor, then heated to 90-94°C with stirring under moderate vacuum (2-6 torr) for 4-5 hours and cooled to room temperature.

[0158] Pigment: Titanium dioxide: Cosmetic White C47-060 (Chempilots) Black iron oxide: Sicovit Black 85 E172 (Chempilot) Brown iron oxide: Sicovit Brown 75 E172 (Chempilot) Red iron oxide: Sicovit Red 30 E172 (Chempilot) Trans Oxide Red: Trans Oxide Red AC1000 (Chempilot) Yellow iron oxide: Sicovit Yellow 10 E172 (Chempilots) Trans Oxide Yellow: Trans Oxide Yellow AC0500 (Chempilots) Phthalocyanine Blue: Phthalocyanine Blue 15 (Chempilots) Phthalocyanine Green: Phthalocyanine Green (Chempilots) Carbazole Violet 23 (Chempilots) Spectraval Blue (Merck KGaA, EMD Performance Materials) Spectraval Green (Merck KGaA, EMD Performance Materials) Spectraval Red (Merck KGaA, EMD Performance Materials) Spectraval White (Merck KGaA, EMD Performance Materials) Candurin® Gold Luster (Merck KGaA, EMD Performance Materials) [Example]

[0159] Clear Base Ink Preparation #1 A bound copolymer was prepared by free radical polymerization of HEMA and MAA with approximately 1.4 weight percent MAA repeat units using AIBN as the initiator and DODT as the chain transfer agent. Copolymerization conditions can be varied to control the composition, molecular weight, and molecular weight distribution of the bound copolymer. The composition was approximately 1.4 weight percent MAA repeat units, approximately 96.6 weight percent HEMA repeat units, and approximately 2 weight percent DODT. The bound copolymer interacts with and stabilizes the pigment / dye dispersion. The bound copolymer was dissolved in a 4:1 (w / w) solution of IPL:1E2P at concentrations ranging from approximately 20 weight percent to approximately 40 weight percent. A typical bound copolymer concentration is 30 weight percent. Solution viscosity can be adjusted as desired by diluting the 4:1 (w / w) solution of IPL:1E2P or 1-propanol. 1-propanol is preferred.

[0160] Color Ink Preparations Colored inks were prepared by mixing pigments and / or dyes at specific concentrations into a clear base ink to impart desired colors, patterns, and / or effects to cosmetic contact lenses. The pigment and dye concentrations can vary from about 1 weight percent to about 25 weight percent depending on the opacity, translucency, or transparency of the printed layer. 1-Propanol can be added after the pigments and dyes have been added to achieve the desired viscosity or to modify the evaporation rate. Table A lists nine exemplary colored ink compositions. The concentrations of specific pigments or dyes are listed by weight percent. The clear base ink contained about 30 weight percent of a binding copolymer composed of about 1.4 weight percent MAA repeat units, about 96.6 weight percent HEMA repeat units, and about 2 weight percent DODT in a 4:1 (w / w) solution of IPL:1E2P. The Brookfield viscosity of these pigmented inks was reduced by adding 1-propanol to the initial pigment / dye dispersion to a Brookfield viscosity of about 5000 centipoise to about 8000 centipoise, preferably about 5500 to 6500 centipoise.

[0161] [Table 6]

[0162] Example 1 The printed contact lenses were produced on an automated pilot production line capable of pad printing and contact lens production, with oxygen gas levels maintained at 0.5 to 5%. Using front curve and base curve molds designed to produce contact lenses with an apex height of 0.020 millimeters or less in the inverted orientation, measured to the surface closest to the eye, and a dSag of less than 1.3% between the non-inverted and inverted lens orientations, an annular clear coat was pad printed onto the front curve mold. The front curve and base curve molds can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front curve mold was made of polystyrene, and the base curve mold was made of Zeonol. The front curve and base curve molds were degassed for approximately 12 hours before use. After the clear coat was sufficiently dry (dry enough to deposit the next layer without lifting or changing the clear coat), an effect layer cliché with the pattern shown in Figure 41A was printed on the clear coat using green ink #1. After the effect layer pattern was sufficiently dry (dry enough to deposit the next layer without lifting or changing the first printed layer), a barrier layer cliché with the pattern shown in Figure 41B was printed using gray ink #2. After the barrier layer was sufficiently dry (dry enough to deposit the next layer without lifting or changing the barrier printed layer), an effect cliché with the pattern shown in Figure 41C was printed using blue ink #3, thereby forming the pattern shown in Figure 41D.

[0163] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a 420-nanometer LED positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 A strength of 1000 MPa was achieved.

[0164] The printed lenses were partially demolded and released from the BC with most of the lens still attached to the FC. The lenses were then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses were transferred to foil-sealed blister packages and then sterilized by autoclaving at 124°C for approximately 18 minutes.

[0165] [Table 7]

[0166] Example 2 Using front curve and base curve molds designed to produce contact lenses with a dSag between the non-inverted and inverted lens orientations of less than 1.3%, or alternatively, an apex height of 0.020 millimeters or less in the inverted orientation, as measured from the edge apex to the surface nearest the eye, the printed contact lenses were produced on an automated pilot production line capable of pad printing and contact lens production, where oxygen gas levels were maintained at 0.5 to 5% and an annular clear coat was pad printed onto the front curve mold. The front curve and base curve molds can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front curve mold was made of polystyrene, and the base curve mold was made of Zeonol. The front curve and base curve molds were degassed for approximately 12 hours before use. After the clear coat was sufficiently dry (sufficiently dry to deposit the next layer without lifting or replacing the clear coat), an effect layer cliché having the pattern shown in Figure 42A was printed on the clear coat using gold ink #8 to create a glitter effect. After the effect layer pattern was sufficiently dry (sufficiently dry to deposit the next layer without lifting or altering the first printed layer), a barrier layer cliché having the pattern shown in Figure 42B was printed using white ink #9. After the barrier layer was sufficiently dry (sufficiently dry to deposit the next layer without lifting or altering the barrier printed layer), an effect layer cliché having the pattern shown in Figure 42C was printed using pink ink #4, thereby creating the pattern shown in Figure 42D.

[0167] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a 420-nanometer LED positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 A strength of 1000 MPa was achieved.

[0168] The printed lenses were partially demolded and released from the BC with most of the lens still attached to the FC. The lenses were then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses were transferred to foil-sealed blister packages and then sterilized by autoclaving at 124°C for approximately 18 minutes.

[0169] Example 3 Using front curve and base curve molds designed to produce contact lenses with a dSag between the non-inverted and inverted lens orientations of less than 1.3%, or alternatively, an apex height of 0.020 millimeters or less in the inverted orientation, as measured from the edge apex to the surface nearest the eye, the printed contact lenses were produced on an automated pilot production line capable of pad printing and contact lens production, where oxygen gas levels were maintained at 0.5 to 5% and an annular clear coat was pad printed onto the front curve mold. The front curve and base curve molds can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front curve mold was made of polystyrene, and the base curve mold was made of Zeonol. The front curve and base curve molds were degassed for approximately 12 hours before use. After the clear coat was sufficiently dry (dry enough to deposit the next layer without lifting or replacing the clear coat), an effect layer cliché with the pattern shown in Figure 15B was printed on the clear coat using yellow ink #5. After the effect layer pattern was sufficiently dry (dry enough to deposit the next layer without lifting or changing the first printed layer), a limbal pattern cliché with the pattern shown in Figure 16A was printed on the clear coat using brown ink #6. After the limbal pattern was sufficiently dry (dry enough to deposit the next layer without lifting or replacing the limbal layer), an effect layer cliché with the pattern shown in Figure 15B was printed using green ink #7 to create a sparkle effect.

[0170] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a 420-nanometer LED positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 A strength of 1000 MPa was achieved.

[0171] The printed lenses were partially demolded and released from the BC with most of the lens still attached to the FC. The lenses were then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses were transferred to foil-sealed blister packages and then sterilized by autoclaving at 124°C for approximately 18 minutes.

[0172] Example 4 Using front curve and base curve molds designed to produce contact lenses with a dSag between the non-inverted and inverted lens orientations of less than 1.3%, or alternatively, an apex height of 0.020 millimeters or less in the inverted orientation, as measured from the edge apex to the surface nearest the eye, the printed contact lenses were produced on an automated pilot production line capable of pad printing and contact lens production, where oxygen gas levels were maintained at 0.5 to 5% and an annular clear coat was pad printed onto the front curve mold. The front curve and base curve molds can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front curve mold was made of polystyrene, and the base curve mold was made of Zeonol. The front curve and base curve molds were degassed for approximately 12 hours before use. After the clear coat was sufficiently dry (dry enough to deposit the next layer without lifting or replacing the clear coat), a limbal pattern cliché with the pattern shown in Figure 16A was printed on the clear coat using brown ink #6. After the limbal pattern was sufficiently dry (dry enough to deposit the next layer without lifting or replacing the limbal layer), an effect layer cliché with the pattern shown in Figure 15B was printed on the clear coat using green ink #3. After the effect layer pattern was sufficiently dry (dry enough to deposit the next layer without lifting or replacing the previous printed layer), a barrier layer cliché with the pattern shown in Figure 16C was printed using gray ink #2. After the barrier layer was sufficiently dry (dry enough to deposit the next layer without lifting or replacing the previous printed layer), an effect layer cliché with the pattern shown in Figure 15B was printed using blue ink #3.

[0173] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a 420-nanometer LED positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 A strength of 1000 MPa was achieved.

[0174] The printed lenses were partially demolded and released from the BC with most of the lens still attached to the FC. The lenses were then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses were transferred to foil-sealed blister packages and then sterilized by autoclaving at 124°C for approximately 18 minutes.

[0175] Prophetic Example Clear Base Ink Preparation #1 A bound copolymer was prepared by free radical polymerization of HEMA and MAA with approximately 1.4 weight percent MAA repeat units, using AIBN as the initiator and, optionally, DODT as the chain transfer agent. Copolymerization conditions can be varied to control the composition, molecular weight, and molecular weight distribution of the bound copolymer. A typical composition is approximately 1.4 weight percent MAA repeat units, approximately 96.6 weight percent HEMA repeat units, and approximately 2 weight percent DODT. The bound copolymer interacts with and stabilizes the pigment / dye dispersion. The bound copolymer is dissolved in a 4:1 (w / w) solution of IPL:1E2P at a concentration ranging from approximately 20 weight percent to approximately 40 weight percent. A typical bound copolymer concentration is 30 weight percent. Solution viscosity can be adjusted as desired by diluting the 4:1 (w / w) solution of IPL:1E2P with 1-propanol, which is preferred.

[0176] Color Ink Preparations Colored inks are prepared by mixing pigments and / or dyes at specific concentrations into a clear base ink to impart desired colors, patterns, and / or effects to cosmetic contact lenses. The pigment and dye concentrations may vary from about 1 weight percent to about 25 weight percent depending on the opacity, translucency, or transparency of the printed layer. 1-Propanol can be added after the pigments and dyes have been added to achieve a desired viscosity or to modify the evaporation rate. Table C lists ten exemplary colored ink compositions. The concentrations of specific pigments or dyes are listed by weight percent. The clear base ink contains about 30 weight percent of a coupling copolymer composed of about 1.4 weight percent MAA repeat units, about 96.6 weight percent HEMA repeat units, and about 2 weight percent DODT in a 4:1 (w / w) solution of IPL:1E2P. The Brookfield viscosity of these pigmented inks is reduced by adding 1-propanol to the initial pigment / dye dispersion to a Brookfield viscosity of about 5000 to about 8000 centipoise, preferably about 5500 to 6500 centipoise.

[0177] [Table 8]

[0178] Example 5 Printed contact lenses are fabricated in a glove box with an oxygen gas concentration maintained at 0.5-5%. Using a front curve mold and base curve mold designed to produce contact lenses with an apex height of 0.020 mm or less in the inverted orientation, measured to the surface closest to the eye, and a dSag of less than 1.3% between the non-inverted and inverted lens orientations, an annular clear coat is pad-printed onto the front curve mold using a laboratory-scale pad printer. The front curve mold and base curve mold can be fabricated from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Zinc are preferred. The front curve mold and base curve mold are typically degassed for approximately 12 hours before use. After the clear coat has dried, a limbal cliché with the pattern shown in Figure 14A is printed onto the clear coat using brown ink #16. After the limbal pattern has dried, an inner effect cliché with the pattern shown in Figure 14B is printed onto the clear coat using orange ink #15. After the inner effect pattern dries, an outer effect cliche having the pattern shown in FIG. 14C is printed on the clear coat using gray ink #4, thereby forming the pattern shown in FIG. 14D. An optional barrier layer can be printed. For example, the outer effect cliche having the pattern shown in FIG. 14C can be printed on the clear coat using black ink #20. A second clear coat can also be printed to separate the non-inverted and inverted pattern print layers. Here, a limbal cliche having the pattern shown in FIG. 15A is printed on the clear coat using brown ink #16. After the limbal pattern dries, an inner effect cliche having the pattern shown in FIG. 15B is printed on the clear coat using red ink #19, which adds a different color and a shimmer effect. After the inner effect pattern dries, an outer effect cliche having the pattern shown in FIG. 15C is printed on the clear coat using gray ink #14, thereby forming the pattern shown in FIG. 15D.The second set of printed layers can also be rotationally offset from the first set of printed layers so that some sides of the first pattern can be seen through the second pattern, and vice versa.

[0179] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a 420-nanometer LED positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 Achieve a strength of.

[0180] The printed lenses are partially demolded and released from the BC with most of the lens still attached to the FC. The lenses are then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses are transferred into vials and subsequently sterilized by autoclaving at 121°C for approximately 30 minutes.

[0181] Example 6 Printed contact lenses are fabricated in a glove box with an oxygen gas concentration maintained at 0.5-5%. Using front curve and base curve molds designed to produce contact lenses with an apex height of 0.020 mm or less in the inverted orientation, measured to the surface closest to the eye, and a dSag of less than 1.3% between the non-inverted and inverted lens orientations, an annular clear coat is pad-printed onto the front curve mold using a laboratory-scale pad printer. The front curve and base curve molds can be fabricated from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Zinc are preferred. The front curve and base curve molds are typically degassed for approximately 12 hours before use. After the clear coat dries, a limbal cliché with the pattern shown in Figure 14A is printed onto the clear coat using blue ink #12. After the limbal pattern dries, an inner effect cliché with the pattern shown in Figure 14B is printed onto the clear coat using green ink #13. After the inner effect pattern dries, an outer effect cliche having the pattern shown in FIG. 14C is printed on the clear coat using gray ink #14, thereby creating the pattern shown in FIG. 14D. An optional barrier layer can be printed. For example, the outer effect cliche having the pattern shown in FIG. 14C can be printed on the clear coat using black ink #20. A second clear coat can also be printed to separate the non-inverted and inverted pattern print layers. Here, a limbal cliche having the pattern shown in FIG. 15A is printed on the clear coat using blue ink #10. After the limbal pattern dries, an inner effect cliche having the pattern shown in FIG. 15B is printed on the clear coat using green ink #18, which has a different green color and a shimmer effect. After the inner effect pattern dries, an outer effect cliche having the pattern shown in FIG. 15C is printed on the clear coat using blue ink #12, thereby creating the pattern shown in FIG. 15D.The second set of printed layers can also be rotationally offset from the first set of printed layers so that some sides of the first pattern can be seen through the second pattern, and vice versa.

[0182] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a 420-nanometer LED positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 Achieve a strength of.

[0183] The printed lenses are partially demolded and released from the BC with most of the lens still attached to the FC. The lenses are then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses are transferred into vials and subsequently sterilized by autoclaving at 121°C for approximately 30 minutes.

[0184] Example 7 Printed contact lenses are fabricated in a glove box with an oxygen gas concentration maintained at 0.5-5%. Using front curve and base curve molds designed to produce contact lenses with an apex height of 0.020 mm or less in the inverted orientation, measured to the surface closest to the eye, and a dSag of less than 1.3% between the non-inverted and inverted lens orientations, an annular clear coat is pad-printed onto the front curve mold using a laboratory-scale pad printer. The front curve and base curve molds can be fabricated from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Zinc are preferred. The front curve and base curve molds are typically degassed for approximately 12 hours before use. After the clear coat dries, a limbal cliché with the pattern shown in Figure 14A is printed onto the clear coat using brown ink #16. After the limbal pattern dries, an inner effect cliché with the pattern shown in Figure 14B is printed onto the clear coat using green ink #18. After the internal effect pattern dries, a thin clear layer is printed to provide a depth or three-dimensional effect. After the clear layer dries, an external effect cliché with the pattern shown in FIG. 14C is printed on the clear coat using black ink #20, thereby forming the pattern shown in FIG. 14D. An optional barrier layer can be printed. A second clear coat can also be printed to separate the non-inverted and inverted pattern print layers. Here, a limbal cliché with the pattern shown in FIG. 15A is printed on the clear coat using gray ink #14. After the limbal pattern dries, an internal effect cliché with the pattern shown in FIG. 15B is printed on the clear coat using red ink #17, a different color while maintaining the shimmer effect. After the internal effect pattern dries, an external effect cliché with the pattern shown in FIG. 15C is printed on the clear coat using black ink #20, thereby forming the pattern shown in FIG. 15D. The second set of printed layers can also be rotationally offset from the first set of printed layers so that some sides of the first pattern can be seen through the second pattern, and vice versa.

[0185] Once the print layer was dry, approximately 100 microliters of the RMM listed in Table B was dispensed onto the printed front curve mold at ambient temperature. The RMM was prepared by dissolving the relative amounts of reactive components listed in Table B in BAGE to create a 52:48 (w / w) solution of reactive components to diluent. The base curve mold was then placed on top of the front curve mold. The pallet containing the mold assembly was then moved into a curing tunnel at 60-70°C. The time between dispensing the RMM and entering the curing chamber was controlled to allow the RMM to diffuse into the print layer without smearing. The RMM was photopolymerized around the print layer using a TL03 bulb positioned above the pallet at approximately 5 mW / cm for approximately 4 minutes. 2 Achieve a strength of.

[0186] The printed lenses are partially demolded and released from the BC with most of the lens still attached to the FC. The lenses are then hydrated by immersing them in DIW containing approximately 800 ppm Tween 80 at 70°C for approximately 1 hour, followed by equilibration in the packing solution at 70°C for an additional 1 hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses are transferred into vials and subsequently sterilized by autoclaving at 121°C for approximately 30 minutes.

[0187] Example 8 For silicone hydrogel RMMs such as senofilcon A, the binding copolymer is typically different from conventional RMMs or those based on HEMA. A binding copolymer made from HEMA and silicone monomers or macromers (e.g., a copolymer made from HEMA and mPDMS) is typically required to stabilize the ink formulation and control RMM diffusion. Such copolymers can be random or block copolymers. The ink formulation can also contain other polymers, such as poly(N-vinylpyrrolidone), to better control the diffusion of the RMM through the print layer. In other respects, the process for making reversible cosmetic contact lenses from silicone hydrogel formulations is identical to that detailed for conventional hydrogels: sequentially printing two cosmetic patterns onto a front curve mold using an optimized silicone hydrogel ink, dispersing a silicone hydrogel RMM onto the printed front curve, placing a base curve mold on top of the front curve mold, and curing the RMM between the two molds; the front curve mold and base curve mold are designed to produce contact lenses with a dSag of less than 1.3% between the non-inverted and inverted lens orientations, or an apex height measured from the edge apex to the surface nearest the eye of 0.020 millimeters or less in the inverted orientation. The curing conditions for silicone hydrogel formulations are typically different from those for conventional hydrogel formulations. Lens release and extraction protocols also typically require organic solvents or aqueous alcohol solutions for silicone hydrogel lenses, unlike conventional hydrogel lenses.

[0188] A typical silicone hydrogel lens demolding and extraction method is described as follows: The printed lenses were demolded with most of the lenses still attached to the FC, and then demolded by soaking the lenses in 70% IPA for approximately 1 or 2 hours, followed by washing twice with 70% IPA, optionally twice with 25% IPA, twice with DIW, and finally twice with borate-buffered packing solution. Each wash step lasted approximately 30 minutes. Those skilled in the art will appreciate that the exact lens demolding process, with respect to the concentration of the aqueous isopropanol, the number of washes with each solvent, and the duration of each step, can vary depending on the lens formulation and mold material. The goal of the lens demolding process is to demold all lenses without defects and transition from a diluent-swollen network to a packing solution-swollen hydrogel. The lenses were then transferred into vials and sterilized by pressure treatment at 122°C for 30 minutes.

[0189] [Embodiment] (1) A reversible eye enhancement contact lens, the reversible eye enhancement lens comprising: a. a body comprising a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a peripheral thickness, and a center thickness; b. one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that a dSag is less than 1.3% when comparing a first orientation of the body in which at least a portion of the first surface abuts the eye of the wearer to a second orientation of the body in which at least a portion of the second surface abuts the eye of the wearer; c. the body also comprises a first region corresponding to a scleral region of the eye, a second region corresponding to a limbal region of the eye, and a third region corresponding to an iris region of the eye; d. A reversible eye-enhancing contact lens, wherein colorant is incorporated into the first region, the second region, the third region, or a combination thereof in the form of at least partially overlapping printed layers having a first design viewable in the first orientation that is different from a second design viewable in the second orientation. (2) A reversible eye-enhancing contact lens as described in embodiment 1, wherein the printed layer has a design that overlaps and enhances the iris using an internal effect design graphic and an external effect design graphic, and at least the first design or the second design is opaque. (3) A reversible eye-enhancing contact lens as described in embodiment 1, wherein the printed layer has at least two designs as a first design and a second design that overlap with some overlap and with a barrier layer in between and that enhance the iris using an internal effect design graphic and an external effect design graphic. (4) The reversible eye enhancement contact lens of any one of claims 1 to 3, wherein at least the first design or the second design is translucent. (5) The reversible eye enhancement contact lens of any one of claims 1 to 3, wherein the barrier layer is at least partially opaque.

[0190] (6) The reversible eye enhancement contact lens of embodiment 5, wherein the barrier layer forms a limbal design graphic common to at least the first design or the second design. (7) A reversible eye-enhancing contact lens as described in embodiment 1, wherein at least the first design and the second design use the inner effect design graphic and the outer effect design graphic to enhance the iris such that the inner effect design graphic and the outer effect design graphic form a blending effect between the first design and the second design. (8) The reversible eye enhancement contact lens of embodiment 7, wherein the inner effect design graphic or the outer effect design graphic that creates the blending effect is translucent or opaque. (9) The reversible eye enhancement contact lens of embodiment 7, wherein only the first design includes a blending effect, and the first design and the second design are separated by a barrier layer. (10) The reversible eye enhancement contact lens of embodiment 7, wherein at least the first design or the second design includes a limbal design graphic.

[0191] (11) The reversible eye-enhancing contact lens of any one of claims 1 to 3, wherein the printed layer further comprises one or more clear layers that create observable depth for the first design or the second design. (12) The reversible eye enhancement contact lens of embodiment 1, further comprising an annular clear coat base layer covering the first region, the second region, and the third region. (13) The reversible eye enhancement contact lens of embodiment 12, further comprising a bulk lens material covering the annular clear coat base layer and the first, second, and third regions. (14) The reversible eye enhancement contact lens of any one of embodiments 1 to 3, wherein the first design and the second design differ in colorant, color, limbal design graphic, inner effect design graphic, outer effect design graphic, barrier layer, clear coat base layer, or a combination thereof. (15) The reversible eye enhancement contact lens of any one of claims 1 to 4, wherein the colorant comprises a metal oxide pigment, a coated metal oxide pigment, an organic dye, an interference pigment, and combinations thereof.

[0192] (16) A reversible eye-enhancing contact lens as described in any one of embodiments 1 to 5, wherein one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that dSag is less than 1.2% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. (17) A reversible eye-enhancing contact lens as described in any one of embodiments 1 to 5, wherein one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that dSag is less than 1.1% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. (18) A reversible eye-enhancing contact lens as described in any one of embodiments 1 to 5, wherein one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that dSag is less than 1.0% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. (19) The reversible eye-enhancing contact lens of any one of claims 1 to 8, wherein the body exhibits a modulus of elasticity of 150 kPa to 1000 kPa when measured in accordance with ANSI Z80.20. (20) The reversible eye-enhancing contact lens of embodiment 19, wherein the body exhibits a modulus of elasticity of 270 kPa to 1000 kPa when measured in accordance with ANSI Z80.20.

[0193] (21) The reversible eye-enhancing contact lens of embodiment 19, wherein the body exhibits a modulus of elasticity of 420 kPa to 1000 kPa when measured in accordance with ANSI Z80.20. (22) A reversible eye enhancement contact lens according to any one of the preceding claims, wherein the diameter of the body is between 13.8 millimeters and 15 millimeters. (23) The reversible eye enhancement contact lens of embodiment 22, wherein the diameter of the body is 14.3 millimeters to 14.8 millimeters. (24) A reversible eye enhancement contact lens according to any one of the preceding claims, wherein the base curve of the body is between 8 millimeters and 8.6 millimeters. (25) The reversible eye enhancement contact lens of embodiment 24, wherein the base curve of the body is between 8 millimeters and 8.3 millimeters.

[0194] (26) The reversible eye enhancement contact lens of embodiment 25, wherein the base curve of the body is between 8 millimeters and 8.1 millimeters. (27) A reversible eye enhancement contact lens according to any one of the preceding claims, wherein the central thickness of the body is between 0.06 millimeters and 0.2 millimeters. (28) The reversible eye enhancement contact lens of embodiment 27, wherein the center thickness of the body is 0.1 millimeters to 0.2 millimeters. (29) A pad printing method for producing a reversible eye enhancement contact lens according to any one of embodiments 1 to 28, comprising: a. printing an annular clear base layer onto a front curve mold; b. printing at least two effect layers onto the annular clear base layer, the effect layers including a limbal design graphic, an interior effect design graphic, an exterior effect design graphic, and combinations thereof; c. Optionally, printing at least one barrier layer between said effect layers; d. Optionally, printing at least one other annular clear base layer between said effect layers; e. dispensing a reactive monomer mixture of bulk lens material onto the front curve mold; f. curing the reactive monomer mixture of the bulk lens material around the clear base layer and the effect layer; g. Removing the mold from the lens; h. Optionally, extracting the lens with a solvent; i. optionally sterilizing the lens by autoclaving; A pad printing method wherein the effect layer is in the form of an at least partially overlapping printed layer having a first design viewable in the first orientation that is different from a second design viewable in the second orientation. 30. The pad printing method of claim 29, wherein the first design and the second design enhance the iris, form a limbal ring, lighten the sclera, and combinations thereof.

[0195] (31) A reversible eye enhancement contact lens, comprising: a. A main body, b. a body having a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a peripheral thickness, and a center thickness; c. an edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that when the lens is in an inverted orientation with at least a portion of the second surface abutting the wearer's eye, the apex height, measured from the edge apex to the surface nearest the eye, is 0.020 millimeters or less; d. the body further comprises a first region corresponding to a scleral region of the eye, a second region corresponding to a limbal region of the eye, and a third region corresponding to an iris region of the eye; e. A reversible eye enhancement contact lens, wherein the colorant is incorporated into the first region, the second region, the third region, or a combination thereof, in the form of at least partially overlapping printed layers having a first design viewable in the first orientation that is different from a second design viewable in the second orientation. (32) The reversible eye enhancement contact lens of embodiment 31, further comprising an annular clear coat base layer covering the first region, the second region, and the third region. (33) The reversible eye-enhancing contact lens of embodiment 31, further comprising a bulk lens material covering the annular clear coat base layer and both the first region, the second region, and the third region. (34) The reversible eye enhancement contact lens of any of embodiments 31 to 33, wherein the first design and the second design in the first orientation and the second orientation differ in colorant, color, limbal design graphic, inner effect design graphic, outer effect design graphic, barrier layer, clear coat base layer, or combinations thereof. 35. The reversible eye enhancement contact lens of any one of claims 31 to 34, wherein the colorant comprises a metal oxide pigment, a coated metal oxide pigment, an organic dye, an interference pigment, and combinations thereof.

[0196] (36) A reversible eye-enhancing contact lens as described in any of embodiments 31 to 35, wherein the edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that dSag is less than 1.2% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. (37) A reversible eye-enhancing contact lens as described in any of embodiments 31 to 36, wherein the edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that dSag is less than 1.1% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. (38) A reversible eye-enhancing contact lens as described in any of embodiments 31 to 36, wherein the edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that a dSag is less than 1.0% when comparing a first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with a second orientation of the body in which at least a portion of the second surface abuts the wearer's eye. (39) The reversible eye-enhancing contact lens of any of embodiments 28 to 38, wherein the body exhibits a modulus of elasticity of 150 kPa to 1000 kPa when measured in accordance with ANSI Z80.20. (40) The reversible eye-enhancing contact lens of embodiment 39, wherein the body exhibits a modulus of elasticity of 270 kPa to 1000 kPa when measured in accordance with ANSI Z80.20.

[0197] (41) The reversible eye enhancement contact lens of embodiment 40, wherein the body exhibits a modulus of elasticity of 420 kPa to 1000 kPa when measured in accordance with ANSI Z80.20. (42) A reversible eye enhancement contact lens according to any one of embodiments 31 to 41, wherein the diameter of the body is between 13.8 millimeters and 15 millimeters. (43) The reversible eye enhancement contact lens of embodiment 42, wherein the diameter of the body is 14.3 millimeters to 14.8 millimeters. (44) The reversible eye enhancement contact lens of embodiment 43, wherein the base curve of the body is between 8 millimeters and 8.6 millimeters. (45) The reversible eye enhancement contact lens of embodiment 44, wherein the base curve of the body is between 8 millimeters and 8.3 millimeters.

[0198] (46) The reversible eye enhancement contact lens of embodiment 45, wherein the base curve of the body is between 8 millimeters and 8.1 millimeters. (47) A reversible eye enhancement contact lens according to any one of embodiments 31 to 46, wherein the center thickness of the body is from 0.06 millimeters to 0.2 millimeters. (48) The reversible eye enhancement contact lens of embodiment 47, wherein the center thickness of the body is 0.1 millimeters to 0.2 millimeters. (49) A pad printing method for producing a reversible eye-enhancing contact lens according to any one of embodiments 31 to 48, comprising: a. printing an annular clear base layer onto a front curve mold; b. printing at least two effect layers onto the annular clear base layer, the effect layers including a limbal design graphic, an interior effect design graphic, an exterior effect design graphic, and combinations thereof; c. Optionally, printing at least one barrier layer between said effect layers; d. Optionally, printing at least one other annular clear base layer between said effect layers; e. dispensing a reactive monomer mixture of bulk lens material onto the front curve mold; f. curing the reactive monomer mixture of the bulk lens material around the clear base layer and the effect layer; g. Removing the mold from the lens; h. Optionally, extracting the lens with a solvent; i. optionally sterilizing the lens by autoclaving; A pad printing method wherein the effect layer is in the form of an at least partially overlapping printed layer having a first design viewable in the first orientation that is different from a second design viewable in the second orientation. (50) The pad printing method of embodiment 49, wherein the first design and the second design enhance the iris, form a limbal ring, lighten the sclera, and combinations thereof.

[0199] (51) A kit comprising at least a pair of reversible eye-enhancing contact lenses according to any one of embodiments 1 to 50, each lens having a first design that provides a subtle change in the design observed for the observed eye and a second design that provides a substantial change in the design observed for the observed eye.

Claims

1. A reversible eye enhancement contact lens, comprising: a. a body comprising a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a peripheral thickness, and a center thickness; b. one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured to provide a dSag of less than 1.3% when comparing a first orientation of the body in which at least a portion of the first surface abuts the eye of a wearer to a second orientation of the body in which at least a portion of the second surface abuts the eye of the wearer; c. the body also comprises a first region corresponding to a scleral region of the eye, a second region corresponding to a limbal region of the eye, and a third region corresponding to an iris region of the eye; d. A reversible eye enhancement contact lens, wherein colorant is incorporated into the first region, the second region, the third region, or a combination thereof in the form of at least partially overlapping printed layers having a first design viewable in the first orientation that differs from a second design viewable in the second orientation.

2. 2. The reversible eye-enhancing contact lens of claim 1, wherein the printed layer comprises a design that overlaps and enhances the iris in the iris region using an internal effect design graphic and an external effect design graphic, and at least the first design or the second design is opaque.

3. 2. The reversible eye-enhancing contact lens of claim 1, wherein the printed layer comprises at least two designs as the first design and the second design, overlapping with at least partial overlap and with a barrier layer in between, and highlighting the iris in the iris region using an inner effect design graphic and an outer effect design graphic.

4. 4. The reversible eye enhancement contact lens of claim 1 or 3, wherein at least the first design or the second design is translucent.

5. The reversible eye-enhancing contact lens of claim 3 , wherein the barrier layer is at least partially opaque.

6. The reversible eye enhancement contact lens of claim 5 , wherein the barrier layer forms a limbal design graphic common with at least the first design or the second design.

7. 10. The reversible eye enhancing contact lens of claim 1, wherein at least the first design and the second design enhance the iris in the iris region using the inner effect design graphic and the outer effect design graphic such that the inner effect design graphic and the outer effect design graphic form a blending effect between the first design and the second design.

8. 8. The reversible eye enhancement contact lens of claim 7, wherein the inner effect design graphic or the outer effect design graphic that creates the blending effect is translucent or opaque.

9. A reversible eye-enhancing contact lens as described in claim 7, wherein only the first design includes the blending effect, and the first design and the second design are separated by a barrier layer.

10. The reversible eye enhancement contact lens of claim 7 , wherein at least the first design or the second design includes a limbal design graphic.

11. 4. The reversible eye enhancement contact lens of claim 1 or 3, wherein the printed layer further comprises one or more clear layers that create observable depth for the first design or the second design.

12. 10. The reversible eye enhancing contact lens of claim 1, further comprising an annular clear coat base layer covering said first region, said second region, and said third region.

13. 13. The reversible eye enhancing contact lens of claim 12, further comprising a bulk lens material covering the annular clear coat base layer and the first, second, and third regions.

14. 4. The reversible eye enhancement contact lens of claim 1, wherein the first design and the second design differ in colorant, color, limbal design graphic, inner effect design graphic, outer effect design graphic, barrier layer, clear coat base layer, or combinations thereof.

15. 5. The reversible eye enhancement contact lens of claim 1, wherein the colorant comprises a metal oxide pigment, a coated metal oxide pigment, an organic dye, an interference pigment, or a combination thereof.

16. 6. A reversible eye-enhancing contact lens according to any one of claims 1 to 5, wherein one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that dSag is less than 1.2% when comparing the first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with the second orientation of the body in which at least a portion of the second surface abuts the wearer's eye.

17. 6. A reversible eye-enhancing contact lens according to any one of claims 1 to 5, wherein one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that dSag is less than 1.1% when comparing the first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with the second orientation of the body in which at least a portion of the second surface abuts the wearer's eye.

18. 6. A reversible eye-enhancing contact lens according to any one of claims 1 to 5, wherein one or more of the diameter, the base curve, the peripheral thickness, or the central thickness are configured such that dSag is less than 1.0% when comparing the first orientation of the body in which at least a portion of the first surface abuts the eye of the wearer with the second orientation of the body in which at least a portion of the second surface abuts the eye of the wearer.

19. 9. The reversible eye enhancing contact lens of any one of claims 1 to 8, wherein the body exhibits a modulus of elasticity of from 150 kPa to 1000 kPa when measured in accordance with ANSI Z80.

20.

20. 20. The reversible eye enhancing contact lens of claim 19, wherein said body exhibits a modulus of elasticity of from 270 kPa to 1000 kPa when measured in accordance with ANSI Z80.

20.

21. 20. The reversible eye enhancing contact lens of claim 19, wherein said body exhibits a modulus of elasticity of from 420 kPa to 1000 kPa when measured in accordance with ANSI Z80.

20.

22. 22. The reversible eye enhancement contact lens of any one of claims 1 to 21, wherein the diameter of the body is between 13.8 millimeters and 15 millimeters.

23. 23. The reversible eye enhancement contact lens of claim 22, wherein the diameter of the body is between 14.3 millimeters and 14.8 millimeters.

24. 24. The reversible eye enhancement contact lens of any one of claims 1 to 23, wherein the base curve of the body is between 8 millimeters and 8.6 millimeters.

25. 25. The reversible eye enhancing contact lens of claim 24, wherein the base curve of the body is between 8 millimeters and 8.3 millimeters.

26. 26. The reversible eye enhancing contact lens of claim 25, wherein the base curve of the body is between 8 millimeters and 8.1 millimeters.

27. 27. The reversible eye enhancement contact lens of any one of claims 1 to 26, wherein the center thickness of the body is from 0.06 millimeters to 0.2 millimeters.

28. 28. The reversible eye enhancement contact lens of claim 27, wherein the center thickness of the body is between 0.1 millimeters and 0.2 millimeters.

29. 29. A pad printing method for producing a reversible eye enhancement contact lens according to any one of claims 1 to 28, comprising the steps of: a. printing an annular clear base layer onto a front curve mold; b. printing at least two effect layers onto the annular clear base layer, the effect layers including a limbal design graphic, an interior effect design graphic, an exterior effect design graphic, and combinations thereof; c. printing at least one barrier layer between said effect layers; d. printing at least one other annular clear base layer between said effect layers; e. dispensing a reactive monomer mixture of bulk lens material onto the front curve mold; f. curing the reactive monomer mixture of the bulk lens material around the annular clear base layer and the effect layer; g. Removing the mold from the reversible eye enhancement contact lens; h) extracting said reversible eye enhancement contact lens with a solvent; i. sterilizing the reversible ocular enhancement contact lens by autoclaving; 10. A pad printing method, wherein the effect layer is in the form of an at least partially overlapping printed layer having the first design viewable in the first orientation different from the second design viewable in the second orientation.

30. 30. The pad printing method of claim 29, wherein the first design and the second design enhance the iris in the iris region, form a limbal ring, lighten the sclera region, and combinations thereof.

31. A reversible eye enhancement contact lens, comprising: a. A body, b. a body having a first surface and a second surface opposite the first surface, the body having a diameter, a base curve, a peripheral thickness, and a central thickness; c) an edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that when the reversible eye enhancement contact lens is in a first orientation with at least a portion of the first surface abutting a wearer's eye, and when the reversible eye enhancement contact lens is in a second orientation with at least a portion of the second surface abutting the wearer's eye, an apex height measured from the edge apex to the surface nearest the eye is 0.020 millimeters or less; d. the body further comprises a first region corresponding to a scleral region of the eye, a second region corresponding to a limbal region of the eye, and a third region corresponding to an iris region of the eye; e. A reversible eye enhancement contact lens, wherein colorant is incorporated into the first region, the second region, the third region, or a combination thereof in the form of at least partially overlapping printed layers having a first design viewable in the first orientation that differs from a second design viewable in the second orientation.

32. 32. The reversible eye enhancing contact lens of claim 31, further comprising an annular clear coat base layer covering said first region, said second region, and said third region.

33. 33. The reversible eye enhancing contact lens of claim 32, further comprising a bulk lens material covering both the annular clear coat base layer and the first, second, and third regions.

34. 34. The reversible eye enhancement contact lens of any one of claims 31 to 33, wherein the first design and the second design in the first orientation and the second orientation differ in colorant, color, limbal design graphic, inner effect design graphic, outer effect design graphic, barrier layer, clear coat base layer, or combinations thereof.

35. 35. The reversible eye-enhancing contact lens of claim 34, wherein the colorant comprises a metal oxide pigment, a coated metal oxide pigment, an organic dye, an interference pigment, or a combination thereof.

36. 36. A reversible eye-enhancing contact lens as described in any one of claims 31 to 35, wherein the edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that dSag is less than 1.2% when comparing the first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with the second orientation of the body in which at least a portion of the second surface abuts the wearer's eye.

37. 37. A reversible eye-enhancing contact lens as described in any one of claims 31 to 36, wherein the edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that dSag is less than 1.1% when comparing the first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with the second orientation of the body in which at least a portion of the second surface abuts the wearer's eye.

38. 37. A reversible eye-enhancing contact lens as described in any one of claims 31 to 36, wherein the edge profile and one or more of the diameter, the base curve, or the thickness profile are configured such that dSag is less than 1.0% when comparing the first orientation of the body in which at least a portion of the first surface abuts the wearer's eye with the second orientation of the body in which at least a portion of the second surface abuts the wearer's eye.

39. 39. The reversible ocular enhancing contact lens of any one of claims 28, 31 to 38, wherein the body exhibits a modulus of elasticity of from 150 kPa to 1000 kPa when measured in accordance with ANSI Z80.

20.

40. 40. The reversible eye enhancing contact lens of claim 39, wherein said body exhibits a modulus of elasticity of from 270 kPa to 1000 kPa when measured in accordance with ANSI Z80.

20.

41. 41. The reversible ocular enhancing contact lens of claim 40, wherein said body exhibits a modulus of elasticity of from 420 kPa to 1000 kPa when measured in accordance with ANSI Z80.

20.

42. 42. The reversible eye enhancement contact lens of any one of claims 31 to 41, wherein the diameter of the body is between 13.8 millimeters and 15 millimeters.

43. 43. The reversible eye enhancement contact lens of claim 42, wherein the diameter of the body is between 14.3 millimeters and 14.8 millimeters.

44. 44. The reversible eye enhancing contact lens of claim 43, wherein the base curve of the body is between 8 millimeters and 8.6 millimeters.

45. 45. The reversible eye enhancing contact lens of claim 44, wherein the base curve of the body is between 8 millimeters and 8.3 millimeters.

46. 46. ​​The reversible eye enhancing contact lens of claim 45, wherein the base curve of the body is between 8 millimeters and 8.1 millimeters.

47. 47. The reversible eye enhancement contact lens of any one of claims 31 to 46, wherein the center thickness of the body is from 0.06 millimeters to 0.2 millimeters.

48. 48. The reversible eye enhancement contact lens of claim 47, wherein the center thickness of the body is between 0.1 millimeters and 0.2 millimeters.

49. 39. A pad printing method for producing a reversible eye enhancement contact lens according to any one of claims 36 to 38, comprising the steps of: a. printing an annular clear base layer onto a front curve mold; b. printing at least two effect layers onto the annular clear base layer, the effect layers including a limbal design graphic, an interior effect design graphic, an exterior effect design graphic, and combinations thereof; c. printing at least one barrier layer between said effect layers; d. printing at least one other annular clear base layer between said effect layers; e. dispensing a reactive monomer mixture of bulk lens material onto the front curve mold; f. curing the reactive monomer mixture of the bulk lens material around the annular clear base layer and the effect layer; g. Removing the mold from the reversible eye enhancement contact lens; h) extracting said reversible eye enhancement contact lens with a solvent; i. sterilizing the reversible ocular enhancement contact lens by autoclaving; 10. A pad printing method, wherein the effect layer is in the form of an at least partially overlapping printed layer having a first design viewable in the first orientation that is different from a second design viewable in the second orientation.

50. 50. The pad printing method of claim 49, wherein the first design and the second design enhance the iris in the iris region, form a limbal ring, lighten the sclera region, and combinations thereof.

51. 49. A kit comprising at least a pair of reversible eye-enhancing contact lenses according to any one of claims 1 to 28 and 31 to 48, wherein each lens has a first design that provides a subtle change in the design observed for the observed eye and a second design that provides a substantial change in the design observed for the observed eye.

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