Cosmetic contact lens with reversible effect

Abstract

A reversible eye-enhancing contact lens includes a main body including a first surface and a second surface opposite the first surface, the main body having a diameter, a base curve, a peripheral thickness, and a center thickness, wherein one or more of the diameter, the base curve, the peripheral thickness, or the center thickness are configured such that when a first orientation of the main body in which at least a portion of the first surface abuts a wearer's eye is compared to a second orientation of the main body in which at least a portion of the second surface abuts the wearer's eye, dSag is less than 1.3%; the main body further includes a first region corresponding to a scleral region of the eye; a second region corresponding to a limbal region of the eye; 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 is configured to form a cosmetic design in the first orientation that is different from a cosmetic design in the second orientation. The cosmetic designs in the first and second orientations can differ in colorant, color, limbal design pattern, inner effect design pattern, outer effect design pattern, barrier layer, light-transmissive coating base layer, or a combination thereof. The colorant can include a metal oxide pigment, a coated metal oxide pigment, an organic dye, an interference pigment, and a combination thereof.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 17 / 031,105, filed on September 24, 2021. Background Technology 1. Technical Field

[0004] This invention relates to ophthalmic lenses, and more particularly to reversible cosmetic contact lenses, which provide different enhancements to the appearance of the eyes depending on whether they are worn in a non-reversible or reversible orientation. Such reversible cosmetic contact lenses are manufactured by incorporating multiple effect layers having different patterns, degrees of overlap, and levels of opacity from various dyes, pigments, and colorants into a contact lens mechanically designed for comfort in both non-reversible and reversible orientations. Comfortable, reversible cosmetic contact lenses can be manufactured by minimizing differences in diameter, base curve, center thickness, and / or peripheral thickness between the non-reversible and reversible contact lenses. Reversible cosmetic contact lenses also include at least one annular shaped light-transmitting layer to encapsulate the multiple effect layers and provide high-quality optics in the optical zone of the lens. Although any colorant can be used, reversible cosmetic contact lenses may also incorporate pearlescent pigments in one or more areas to create a glossy, shiny, and colorful appearance in either a non-reversible or reversible orientation, or in both orientations.

[0005] 2. Discussion in related fields

[0006] Contact lenses, or contact lenses, are simply lenses placed on the eye. They are considered medical devices and can be worn to correct vision and / or for cosmetic or other therapeutic reasons. Contact lenses have been commercially used to improve vision since the 1950s. Early contact lenses, made or processed from rigid materials, were relatively expensive and fragile. Furthermore, these early contact lenses were made of materials that did not allow sufficient oxygen to pass through the lens to the conjunctiva and cornea, potentially causing many adverse clinical effects. Although these contact lenses are still used, they are not suitable for all patients due to their poor initial comfort. Subsequent developments in this field led to soft, hydrogel-based contact lenses, which are extremely popular and widely used today. Today's available silicone hydrogel contact lenses combine the beneficial effects of silicone, with its extremely high oxygen permeability, with the proven comfort and clinical performance of hydrogel. In fact, these silicone hydrogel-based contact lenses have higher oxygen permeability values ​​and generally offer greater wearing comfort compared to contact lenses made from earlier rigid materials. On the other hand, rigid, breathable hard contact lenses are made of silicone-containing polymers, but are more rigid than soft contact lenses, and therefore retain their shape and are more durable.

[0007] Currently available contact lenses have been a cost-effective device for vision correction. Thin plastic lenses adhere to the cornea of ​​the eye to correct vision defects, including myopia or nearsightedness, hyperopia or farsightedness, astigmatism (i.e., asphericity in the cornea), and presbyopia (i.e., loss of the lens's ability to adjust). Contact lenses are available in various forms and are made from a variety of materials to provide different functionalities. Daily wear soft contact lenses are typically made from soft polymer materials mixed with water for oxygen permeability. Daily wear soft contact lenses can be either daily disposable or long-term wear. Daily disposable contact lenses are typically worn for one day and then discarded, while long-term wear contact lenses are typically worn for a period of up to thirty days. Tinted soft contact lenses use different materials to provide different functionalities. For example, tinted contact lenses use a light tint to help wearers locate dropped lenses; tinted contact lenses have a clear or semi-transparent tint that enhances the natural color of the eye; tinted contact lenses include opaque tints to alter the color of the eye; and tinted contact lenses are used to enhance certain colors while diminishing others. Bifocal and multifocal contact lenses are specifically designed for presbyopia patients and are available in both soft and rigid types. Topochrome contact lenses are specifically designed for astigmatism patients and are also available in both soft and rigid types. Combined lenses that integrate these different aspects are also available, such as hybrid contact lenses.

[0008] Current contact lens designs are intended to fit in one orientation, thus maximizing the parallax between the primary orientation (non-reversed) (e.g., having a defined internal surface for contact with the eye) and the reverse orientation to prevent confusion between the correct and incorrect orientations during insertion into the eye. Therefore, when a lens is used in its reverse orientation, lens fit, vision, and comfort are negatively impacted.

[0009] EP1364248B1 describes a soft contact lens for fitting into a wearer's eye in either a front-out (non-reversed) orientation or an inside-out (reversed) orientation, wherein in the front-out (non-reversed) orientation, a convex surface and a concave surface are provided, and in the inside-out (reversed) orientation, the front-out (non-reversed) convex surface is converted to a concave surface, and the front-out (non-reversed) concave surface is converted to a convex surface. According to EP1364248B1, this conversion is affected by lens flexure, which is adapted by at least one formation, resulting in an adjustment of the surface profile of either the first surface or the second surface. According to EP1364248B1, the natural resistance of the inside-out (reversed) orientation and the resulting abstract and uncontrolled curvature changes can be reduced or eliminated by a relief area placed within the lens.

[0010] Cosmetic contact lenses may include patterns 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 a ring of colored material that partially or completely covers the limbal region of the wearer's cornea—the junction of the sclera and cornea—when the lens is placed on and centered in the eye. Including a limbal ring can make the iris appear larger, darker, and / or clearer. The combination of the limbal ring and the iris pattern results in 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 the limbal ring creates fusion, depth, contrast, and clarity.

[0011] Other cosmetic contact lenses focus on the sclera rather than the iris, or focus on the sclera in addition to the iris. For example, contact lenses may include a bright peripheral portion, i.e., the area outside the iris region, which can be opaque, semi-opaque, and / or translucent. The bright portion can extend from the edge of the limbus to the edge of the contact lens, thus creating a brighter or whiter impression of the sclera. These contact lenses may also include a limbal ring as described above, which can make the iris appear larger, darker, and / or clearer than otherwise possible.

[0012] While the aforementioned cosmetic contact lenses do enhance the appearance of the eyes, there is a need in the cosmetic lens field for lenses that include designs that suggest and display depth within a given pattern, create variation within the iris area, alter the color of the iris, magnify the iris, and create negative space to allow the natural iris to contribute to the overall design effect.

[0013] Furthermore, cosmetic contact lens wearers may also want to change the type of lenses they wear to alter the effect, such as color or design. This change may occur more than once a day. This typically requires a new set of contact lenses, which can 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 a reversible cosmetic contact lens that offers two different eye enhancement effects depending on how it is worn (non-reversible or reversible). Additionally, there is a need for such a reversible cosmetic contact lens to be comfortable in both non-reversible and reversible orientations. Summary of the Invention

[0014] The cosmetic contact lens with a flip-up effect of the present invention overcomes the limitations associated with the prior art briefly described above.

[0015] Cosmetic contact lenses can be designed to alter the appearance of the eye wearing them in any number of ways, including the color of the entire eye and / or different areas of the eye. While not essential, cosmetic contact lenses can 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 may include clear, translucent, or opaque color enhancers or dyes. Dyes may include organic / inorganic pigments, dyes, or special effects pigments. The printed areas on the contact lenses may include the iris area (iris pattern), the limbal area (limbal ring), the sclera area (scleral brightening), or any combination thereof. Furthermore, the pattern can be continuous, discontinuous, or any combination thereof.

[0016] This invention relates to reversible cosmetic contact lenses, thereby providing different enhancements to the appearance of the eyes depending on whether they are worn in a non-reversible or reversible orientation. Such reversible cosmetic contact lenses are manufactured by incorporating multiple effect layers or design elements having different patterns, overlaps, and opacity levels from various dyes, pigments, and colorants into a contact lens mechanically designed for comfort in both non-reversible and reversible orientations. Comfortable, reversible cosmetic contact lenses can be manufactured by minimizing differences in diameter, base curve, center thickness, and / or peripheral thickness between the non-reversible and reversible contact lenses. Reversible cosmetic contact lenses also include at least one annular shaped light-transmitting layer to encapsulate the multiple effect layers and provide high-quality optics in the lens's optical zone. Reversible cosmetic contact lenses may also incorporate pearlescent pigments in one or more areas to create a glossy, shiny, and colorful appearance in either the non-reversible or reversible orientation, or both.

[0017] The reversible cosmetic contact lenses of this invention utilize multiple effect layers to achieve a unique visual appearance in both non-reversed and reversed orientations. Multi-layered designs can be used to enhance and / or highlight the appearance of the eye upon which the contact lens rests, while maintaining a natural look. These exemplary designs may include three layers: a unique limbal design pattern, a unique inner effect pattern, and a unique outer effect pattern. These layers can be formed using any number of design elements and design principles. For example, lines can be used to define shapes and form contours that mimic or simulate the linear structures, shapes, and outlines found in natural irises. Color and hue values ​​with different levels of translucency and opacity can be used to create blending and contrast, while different colors and hues 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's effect. Perspective in overlapping layers can be used to suggest and display depth within a given pattern. Texture can be used to create variations in the iris. As used in the two-dimensional realm, texture is formed by juxtaposing light and dark features. Light and dark elements, as well as overlapping elements, can also be used to suggest depth and form. To provide different eye enhancements on non-reverse and reverse orientations, multiple effect layers can also add blocking layers, which can be continuous, discontinuous, or any combination thereof, that restrict the effect (color or graphic pattern) to only the non-reverse or reverse orientation. The effectiveness of the blocking layer depends on its position and opacity, and can completely or partially exclude the effect on one orientation or the other.

[0018] The reversible cosmetic contact lens of the present invention may include any of the aforementioned multi-effect layers, incorporating pearlescent pigments to give the wearer's eyes a glossy, sparkling, and colorful appearance. The pigments can be added to any area of ​​the lens, including areas covering the iris and / or sclera. For example, if used on areas covering the sclera, the combination or incorporation of pearlescent pigments will produce a brighter white scleral area with a wet-reflective appearance and a natural look. The incorporation of pearlescent pigments has no significant impact on the manufacturing process of the cosmetic contact lens; therefore, a natural and glossy appearance can be achieved without significant changes.

[0019] This disclosure relates to reversible cosmetic contact lenses and their design and optimization methods, such as through computer simulation performance analysis and prototyping. For example, the peripheral region of the lens can be designed to minimize the parallax of the base curve and diameter between a primary (non-reversed) orientation and an inner-outer (reversed) orientation. The effect of peripheral thickness on this parallax depends on the lens diameter, base curve, and center thickness, which must be optimized along with the peripheral thickness to achieve optimal performance. When the lens base curve and diameter are comparable between a primary (non-reversed) orientation and an inner-outer (reversed) orientation, comparable ocular fit, comfort, and visual performance are expected.

[0020] The lens base curve and diameter can be identified as determining factors for flip fit. According to this disclosure, one or more of the lens base curve and diameter can be configured between a primary (non-flipped) orientation and an inner-surface-outer (flipped) orientation. Therefore, the peripheral region of the lens can be designed such that the deviation in diameter or sagittal depth (dDiam or dSag) between the primary (non-flipped) orientation and the inner-surface-outer (flipped) orientation is minimized. Furthermore, the effect of peripheral thickness can depend on the lens diameter, base curve, and center thickness. One or more of the lens diameter, base curve, and center thickness can be optimized to obtain optimal performance.

[0021] Specifically, the reversible cosmetic contact lens of the present invention may include a body comprising a first surface and a second surface opposite to the first surface, the body having a diameter, a base arc, a peripheral thickness, and a center thickness, wherein one or more of the diameter, the base arc, the peripheral thickness, or the center thickness is configured such that when a first orientation (non-reversed) of the body of the body adjacent to the wearer's eye is compared with a second orientation (reversed) of the body of the body of the wearer's eye adjacent to at least a portion of the first surface, dSag is less than 1.3%.

[0022] Alternatively, the reversible cosmetic contact lens of the present invention may include a body comprising a first surface and a second surface opposite to the first surface, the body having a diameter, a base arc, a thickness profile, and an edge profile, wherein the edge profile and one or more of the diameter, the base arc, or the thickness profile are configured such that when the lens is in a reverse orientation where at least a portion of the second surface is adjacent to the wearer's eye, the vertex height measured from the edge vertex to the nearest surface of the eye is less than or equal to 0.020 mm.

[0023] A method for manufacturing reversible cosmetic contact lenses has been disclosed. Attached Figure Description

[0024] The above and other features and advantages of the invention will become apparent from the following more detailed description of preferred embodiments of the invention as shown in the accompanying drawings.

[0025] Figure 1 This is a plan view of an exemplary non-cosmetic contact lens.

[0026] Figure 2 This is a plan view of a first exemplary cosmetic contact lens.

[0027] Figure 3 This is a plan view of a second exemplary cosmetic contact lens.

[0028] Figure 4This is a plan view of a third exemplary cosmetic contact lens.

[0029] Figure 5 This is a plan view of the fourth exemplary cosmetic contact lens.

[0030] Figure 6 This is a plan view of a first exemplary limbal ring / spoke pattern cosmetic contact lens.

[0031] Figure 7 This is a plan view of a second exemplary limbal ring / spoke pattern cosmetic contact lens.

[0032] Figure 8 This is a plan view of a third exemplary limbal ring / spoke pattern cosmetic contact lens.

[0033] Figure 9 This is a plan view of the fourth exemplary limbal ring / spoke pattern cosmetic contact lens.

[0034] Figure 10 This is a plan view of the fifth exemplary limbal ring / spoke pattern cosmetic contact lens.

[0035] Figure 11 This is a plan view of the sixth exemplary limbal ring / spoke pattern cosmetic contact lens.

[0036] Figure 12 This is a plan view of the seventh exemplary limbal ring / spoke pattern cosmetic contact lens.

[0037] Figure 13 This is a plan view of the eighth exemplary limbal ring / spoke pattern cosmetic contact lens.

[0038] Figure 14A It is a plan view of the first exemplary limbal design pattern according to the present invention.

[0039] Figure 14B It is a plan view of the internal effect design graphic according to the first exemplary embodiment of the present invention.

[0040] Figure 14C It is a plan view of the first exemplary external effect design drawing according to the present invention.

[0041] Figure 14D It is included in the present invention. Figure 14A , Figure 14B and Figure 14C The first exemplary plan view of the three design graphics is a cosmetic contact lens.

[0042] Figure 15A This is a plan view of a second exemplary limbal design pattern according to the present invention.

[0043] Figure 15BIt is a plan view of the inner effect design graphic according to the second exemplary embodiment of the present invention.

[0044] Figure 15C It is a plan view of the second exemplary external effect design drawing according to the present invention.

[0045] Figure 15D It is included in the present invention. Figure 15A , Figure 15B and Figure 15C The second exemplary plan view of the three design graphics of a cosmetic contact lens.

[0046] Figure 16A It is a plan view of the third exemplary limbal design pattern according to the present invention.

[0047] Figure 16B It is a plan view of the third exemplary external effect design drawing according to the present invention.

[0048] Figure 16C It is a plan view of the internal effect design graphic according to the third exemplary embodiment of the present invention.

[0049] Figure 16D It is included in the present invention. Figure 16A , Figure 16B and Figure 16C The third exemplary design graphic is a plan view of a cosmetic contact lens.

[0050] Figure 17A This is a plan view of the fourth exemplary limbal design pattern according to the present invention.

[0051] Figure 17B It is a plan view of the fourth exemplary external effect design drawing according to the present invention.

[0052] Figure 17C It is a plan view of the inner effect design graphic according to the fourth exemplary embodiment of the present invention.

[0053] Figure 17D It is included in the present invention. Figure 17A , Figure 17B and Figure 17C The fourth exemplary plan view of the three design graphics is a cosmetic contact lens.

[0054] Figure 18A This is a plan view of the fifth exemplary limbal design pattern according to the present invention.

[0055] Figure 18B It is a plan view of the internal effect design graphic according to the fifth exemplary embodiment of the present invention.

[0056] Figure 18C It is a plan view of the fifth exemplary external effect design drawing according to the present invention.

[0057] Figure 18D It is included in the present invention. Figure 14A , Figure 14B and Figure 14C The fifth exemplary plan view of the three design graphics is a cosmetic contact lens.

[0058] Figure 19 It is a graphical representation of the general pad printing process.

[0059] Figure 20 It is a more detailed diagrammatic representation of the pad printing process.

[0060] Figure 21 This is a schematic representation of the layers that constitute an exemplary contact lens.

[0061] Figure 22 This is a schematic representation of an exemplary translucent substrate pad printing plate according to the present invention.

[0062] Figure 22A This is an exploded view of a portion of the translucent substrate pad printing plate according to the present invention.

[0063] Figure 22B This is an exploded cross-section of the translucent substrate pad printing plate according to the present invention.

[0064] Figure 23 This is a schematic representation of the layers constituting a cosmetic contact lens having an annular light-transmitting base layer according to the present invention.

[0065] Figure 24 This is a schematic diagram of a cosmetic contact lens with a bright sclera containing pearlescent pigments according to the present invention.

[0066] Figure 25 This is a plan view of an exemplary limbal ring / spoke pattern cosmetic contact lens having a mica-based pearlescent pigment in the limbal portion according to the present invention.

[0067] Figure 26 This is a plan view of an exemplary effect design pattern corresponding to the iris region of the wearer's eye according to the present invention, the effect design pattern comprising a mica-based pearlescent pigment.

[0068] Figure 27A This is a schematic diagram of a soft contact lens in its primary orientation and its encapsulation configuration.

[0069] Figure 27B A schematic illustration of a reversed soft contact lens (e.g., inner surface facing out) and its encapsulation configuration.

[0070] Figures 28A to 28B It shows the primary orientation ( Figure 2 A) and reverse or inner face in outer orientation ( Figure 2 Strain modeling of conventional soft contact lenses (B).

[0071] Figures 29A to 29B Strain modeling of a soft contact lens (e.g., with optimized peripheral thickness) according to this disclosure is shown, wherein the lens is in a primary orientation ( Figure 29A ) and reverse or inner face in outer orientation ( Figure 29B ).

[0072] Figures 30A to 30B A list of ratings for the survey of fourteen (14) subjects is shown.

[0073] Figure 31 A graph is shown that illustrates the relationship between simulated dSag and the survey score on the difficulty of identifying whether a lens is inside out.

[0074] Figure 32 A graph is shown illustrating the resulting design space for diameter, base arc, and CT, as well as the effect of diameter, base arc, and CT on the simulated index dSag, indicated by the size of a marker (e.g., the diameter of a circular marker).

[0075] Figure 33 A model of a conventional contact lens with its peripheral edge wrapped in the primary orientation is shown.

[0076] Figure 34 A model of a conventional contact lens with a peripheral edge that is either reversed or has an inner surface facing outwards is shown.

[0077] Figure 35 A model of the peripheral edge of the contact lens according to the invention, wrapped in the primary orientation, is shown.

[0078] Figure 36 A model of a contact lens according to the invention is shown, with a peripheral edge that is either reversed or has an inner surface oriented outward.

[0079] Figure 37A , Figure 37B , Figure 37C and Figure 37D The graphs show the optical analysis based on a 0.00D lens in both primary orientation and reverse or inner surface outward orientation.

[0080] Figure 38A , Figure 38B , Figure 38C and Figure 38D The graphs show the optical analysis of a -4.00D lens in both primary orientation and reverse orientation or inner surface in outer orientation.

[0081] Figure 39A , Figure 39B , Figure 39C and Figure 39D The graphs show the optical analysis based on the +4.00D lens in both primary orientation and reverse or inner surface outward orientation.

[0082] Figure 40 This illustrates the changes in aesthetic design that occur as the flip-up contact lens is reversed.

[0083] Figure 41A This is a schematic representation of the effect layer pad printing plate according to the present invention.

[0084] Figure 41B This is a schematic representation of a patterned barrier layer pad printing plate according to the present invention.

[0085] Figure 41C This is a pictorial representation of the effect of the pad printing plate according to the present invention.

[0086] Figure 41D This is a pictorial representation of the printed pattern according to the present invention.

[0087] Figure 42A This is a schematic representation of the effect layer pad printing plate according to the present invention.

[0088] Figure 42B This is a schematic representation of a patterned barrier layer pad printing plate according to the present invention.

[0089] Figure 42C This is a pictorial representation of the effect of the pad printing plate according to the present invention.

[0090] Figure 42D This is a pictorial representation of the printed pattern according to the present invention. Detailed Implementation

[0091] Contact lenses, or contact lenses, are simply lenses placed on the eye. They are considered medical devices and can be worn to correct vision and / or for cosmetic or other therapeutic reasons. Contact lenses have been commercially used to improve vision since the 1950s. Early contact lenses, made or processed from rigid materials, were relatively expensive and fragile. Furthermore, these early contact lenses were made of materials that did not allow sufficient oxygen to pass through the lens to the conjunctiva and cornea, potentially causing many adverse clinical effects. Although these contact lenses are still used, they are not suitable for all patients due to their poor initial comfort. Subsequent developments in this field led to soft, hydrogel-based contact lenses, which are extremely popular and widely used today. Today's available silicone hydrogel contact lenses combine the beneficial effects of silicone, with its extremely high oxygen permeability, with the proven comfort and clinical performance of hydrogels. Essentially, these silicone hydrogel-based contact lenses offer higher oxygen permeability and generally greater wearing comfort compared to contact lenses made from earlier rigid materials. However, these new contact lenses are not without their limitations.

[0092] This invention relates to reversible cosmetic contact lenses, thereby providing different enhancements to the appearance of the eyes depending on whether they are worn in a non-reversible or reversible orientation. Such reversible cosmetic contact lenses are manufactured by incorporating multiple effect layers with different patterns, overlaps, and opacity levels from various dyes, pigments, and colorants into a contact lens mechanically designed for comfort in both non-reversible and reversible orientations. Comfortable, reversible cosmetic contact lenses can be manufactured by minimizing differences in diameter, base curve, center thickness, and / or peripheral thickness between the non-reversible and reversible contact lenses. The reversible cosmetic contact lens also includes at least one annular translucent layer to encapsulate the multiple effect layers and provide high-quality optics in the lens's optical zone. The reversible cosmetic contact lens may also incorporate pearlescent pigments in one or more areas to create a glossy, shiny, and colorful appearance in either the non-reversible or reversible orientation, or both.

[0093] The reversible cosmetic contact lenses of this invention utilize multiple effect layers to achieve a unique visual appearance in both non-reversed and reversed orientations. Multi-layered designs can be used to enhance and / or highlight the appearance of the eye upon which the contact lens rests, while maintaining a natural look. These exemplary designs may include three layers: a unique limbal design pattern, a unique inner effect pattern, and a unique outer effect pattern. These layers can be formed using any number of design elements and design principles. For example, lines can be used to define shapes and form contours that mimic or simulate the linear structures, shapes, and outlines found in natural irises. Color and hue values ​​with different levels of translucency and opacity can be used to create blending and contrast, while different colors and hues 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's effect. Perspective in overlapping layers can be used to suggest and display depth within a given pattern. Texture can be used to create variations in the iris. As used in the two-dimensional realm, texture is formed by juxtaposing light and dark features. Light and dark elements, as well as overlapping elements, can also be used to suggest depth and form. To provide different eye enhancements on non-reverse and reverse orientations, multiple effect layers can also add blocking layers, which can be continuous, discontinuous, or any combination thereof, that restrict the effect (color or graphic pattern) to only the non-reverse or reverse orientation. The effectiveness of the blocking layer depends on its position and opacity, and can completely or partially exclude the effect on one orientation or the other.

[0094] Multiple Effects Layers

[0095] Now refer to Figure 1The diagram illustrates a plan view of an exemplary non-cosmetic contact lens 100. The contact lens 100 includes an optical region 102, a peripheral region 104 surrounding the optical region 102, a rear-curved surface designed to contact an individual's eye when worn, and an anterior-curved surface opposite the rear-curved surface. The optical region 102 is the portion of the contact lens 100 through which vision correction can be obtained. In other words, the optical region 102 provides vision correction and is designed for specific needs, such as single-vision myopia or hyperopia correction, astigmatic vision correction, bifocal vision correction, multifocal vision correction, custom correction, or any other design that provides vision correction. The peripheral region 104 surrounds the optical region 102 and provides mechanical stability to the contact lens 100 on the eye. In other words, the peripheral region 104 provides mechanical features that affect the positioning and stability of the contact lens 100 on the eye, including centering and orientation. Orientation is fundamental when the optical region 102 includes non-rotationally symmetric features such as astigmatic correction and / or higher-order aberration correction. In some contact lens designs, an optional intermediate region between the optical region 102 and the peripheral region 104 can be utilized. The optional intermediate region ensures that the optical region 102 and the peripheral region 104 blend smoothly.

[0096] Figure 1 The lens 100 shown is circular, but can be any convenient shape for contacting the lens, such as elliptical or truncated circular. In addition to being circular or non-circular, the contact lens 100 can also be planar or non-planar.

[0097] Cosmetic contact lenses are designed to enhance or alter the appearance of the eye that wears them. While not essential, cosmetic contact lenses can also be used to correct refractive errors. Furthermore, cosmetic contact lenses can have direct medical applications, such as restoring the appearance of damaged eyes. Individuals with aniridia, iris loss, pupillary deformities, iris damage, and / or arcus senilis or corneal arcus (a condition that brightens or discolors the limbal region of the cornea) can use colored contact lenses that will give the appearance of a complete iris. Cosmetic contact lenses may include translucent / transparent color enhancers, dyes, opaque color dyes, artificial iris patterns, limbal rings, scleral brightening tints, and / or any combination of the above.

[0098] More specifically, cosmetic contact lenses can be used to brighten the sclera and / or have patterns including a limbal ring to enhance the clarity of the wearer's iris, thereby making the iris appear larger to an observer. Additionally, cosmetic contact lenses may have additional patterned elements that completely or preferably partially cover the wearer's iris. Cosmetic lenses can be used to enhance the iris of individuals with dark eyes, but can also be used to enhance the iris of lens wearers with light eyes.

[0099] Reference Figure 2This illustrates a first exemplary cosmetic contact lens 200. While this lens 200 is included in the above description... Figure 1 The contact lens 100 is defined within the optical and peripheral zones, but different terms are used to describe the various zones of the cosmetic contact lens. The cosmetic contact lens 200 includes a central zone 202, the size of which is set to substantially correspond to the size and position of an individual's pupil. The central zone 202 is generally uncolored or undesigned to avoid interfering with visual acuity. A central portion 204 surrounds the central zone 202, and the size of this central portion is set to substantially correspond to the size and position of an individual's iris. The central portion 204 may include one or more colors and / or patterns 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 peripheral edge of the contact lens 200. The peripheral portion 206 includes an annular shape having an inner diameter measured from point 201 and an outer diameter measured from point 203, which may, but does not necessarily, coincide with the outer edge of the contact lens 200 as a whole. The peripheral portion 206 may be colored with a bright color, such as white, near-white, off-white, light yellow, light blue, light pink, light green, or any combination thereof. The light color is designed to gradually blend with the wearer's sclera.

[0100] The peripheral portion 206 is colored to enhance the appearance of the sclera. The coloring of the peripheral portion 206 can be opaque, translucent, or somewhere between opaque and translucent, or translucent. Exemplary embodiments enhance the appearance of the sclera by providing it with a fresh and natural look. As used herein, opaque should be understood to mean a color that allows an average light transmittance of 0% to about 50% in the 380nm to 780nm range, and preferably 7% to about 50%. As used herein, translucent should be understood to mean a color that allows an average light transmittance of about 50% to about 85% in the 380nm to 780nm range, and preferably about 65% to about 85%.

[0101] Figure 3A second exemplary cosmetic contact lens 300 is shown. The cosmetic contact lens 300 includes a central region 302, a central portion 304 surrounding the central region 302, a peripheral portion 306 surrounding the central portion 304, and a limbal ring 308. As described herein, the limbal ring is essentially a ring-shaped band of color that partially or completely covers the limbal region of the lens wearer when the lens is placed on and centered in the eye. In some exemplary embodiments, the limbal ring may be larger to create a halo effect. In this exemplary embodiment, the tinting in the peripheral portion 306 varies from or may vary from opaque to translucent or transparent, from the inner diameter measured from point 301 to the outer diameter measured from point 303. As in the previously described exemplary embodiments, 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 contrast between the iris and the dark limbal ring, while providing the additional benefit of the bright tinting applied to the peripheral portion 306. The limbal ring 308 may have any suitable width or pattern that allows the ring 308 to blend naturally with the iris, the central colored / pattern 304, and the light-colored peripheral portion 306. The limbal ring 308 may be translucent or opaque.

[0102] Figure 4 A third exemplary cosmetic contact lens 400 is shown, which has a bright tint applied in a geometric pattern in a peripheral portion 406. The cosmetic contact lens 400 includes a central region 402, a central portion 404 surrounding the central region 402, a peripheral portion 406 surrounding the central portion 404, and a limbal ring 408. Figure 3 and Figure 4 The difference between the contact lenses lies in the geometric pattern in the peripheral portion 406. In this exemplary cosmetic lens 400, the geometric pattern presents the appearance of circles 410 removed from the lens surface (otherwise they would be colored white), such that each circle 410 contacts its adjacent circle 410 at a tangent near the limbal ring 408 and separates at the outermost diameter of the pattern to blend with the natural sclera. In a preferred embodiment, the scleral imprint (corresponding to the area of ​​the peripheral portion 406) changes from opaque at the limbal edge to a matrix pattern to blend with the natural sclera. While this exemplary embodiment utilizes circles 410 as the geometric shape, it is important to note that any geometric shape can be used. It can also be considered as rows and columns of cross-shaped bright structures formed by circles 410. As shown, circles 412 can also extend into the pattern in the central portion 404.

[0103] Patterns including geometric shapes can be derived from the above-mentioned... Figure 4 The structure of the described regular shape is formed, or is formed by, in such a way as Figure 5The illustrated cosmetic contact lens 500 is formed by a plurality of random dots or shapes 510 in both the central portion 504 and the peripheral portion 506. In this exemplary contact lens 500, the central region 502 and the limbal ring 508 do not have a pattern, such as spokes or fusion. Any convenient shape can be used to convey a realistic or enhanced sense of color, especially where such geometry contributes to the desired hue or shade. The dots used can include any size and shape. The dots contribute to the fusion of the boundaries of the different elements of the cosmetic contact lens.

[0104] According to other exemplary embodiments, cosmetic lenses may include a limbal ring and a plurality of conical spokes. As described above, the limbal ring is an annular band that partially or substantially completely covers the limbal region of the lens wearer, or the junction of the sclera and cornea, when the lens is placed on and centered in the eye. Preferably, the limbal ring substantially completely covers the limbal region. The innermost boundary or edge of the limbal ring closest to the geometric center of the lens may form a circle with a diameter of about 8 mm to about 12 mm, preferably about 9 mm to about 11 mm, centered on the geometric center of the lens. The ring may have any suitable width, preferably about 0.5 mm to about 2.5 mm, more preferably about 0.75 mm to about 1.25 mm.

[0105] Extending inward from the innermost boundary of the limbal ring toward the geometric center of the lens is a generally triangular structure, similar to spokes in a wheel. The tapered spokes may, but preferably do not extend over the entire iris portion of the lens, meaning the portion of the lens covering the iris when the lens is on and centered in the eye. Instead, preferably, the spokes extend inward from the innermost edge of the limbal ring such that the innermost edge of the spoke pattern is located approximately 6 mm or more, more preferably approximately 7 mm or more, from the geometric center of the lens. The spokes may be uniform or varied in shape and size, and their length is preferably from approximately 1 mm to approximately 2 mm.

[0106] exist Figure 6The image shows a first exemplary embodiment of a limbal ring-conical spoke pattern on a contact lens 600. In this exemplary embodiment, the limbal ring 602 is a black, opaque band approximately 1 mm wide. Starting from 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 conical spokes 606, the innermost boundaries 612 of which form circles with a diameter of 7 mm, as measured from the geometric center of the contact lens 600. Although all spokes 606 are generally constructed similarly, preferably, no single spoke 606 is identical to any other spoke 606. The spokes 606 are scattered or demarcated by spaces 608, in which no elements exist. Spaces 608 are also generally constructed similarly, but preferably, no single space 608 has a construction identical to either space 608 or any other spoke 606. Region 610 is the area without patterned elements, as shown in the figure. This region will partially constitute the iris of the wearer's eye and the entire pupil, or the portion of the lens covering the pupil when the lens is on and centered on the eye. As shown, region 610 is translucent, but it can also be colored translucently or opaquely. The innermost boundary 604 shown has a uniform, regular shape, but it can also be an uneven, irregular boundary. Similarly, while the conical spoke boundary 612 forms a substantially uniform boundary, it can also form an uneven boundary.

[0107] Figure 7 An alternative tapered spoke pattern is shown on the contact lens 700. In this exemplary embodiment, a plurality of randomly arranged tapered spokes 706 extend inward from the innermost boundary 702 of the limbal ring 704 toward the geometric center of the contact lens 700. In this exemplary embodiment, the tapered spokes 706 include one or more wavy lines that gradually taper toward the geometric center of the contact lens 700. As shown, the innermost limbal ring boundary 702 has a non-uniform, irregular shape. Region 708 is the area in which no patterned elements are present; this area will partially constitute the iris portion of the wearer and the entire pupil portion of the wearer's eye, as described above.

[0108] Figure 8Another conical spoke pattern is shown on the contact lens 800. In this exemplary embodiment, a plurality of spokes 806 and 808 extend inward from the innermost boundary 802 of the limbal ring 804 to the geometric center of the contact lens 800, wherein spokes 806 are longer than spokes 808, and both spokes 806 and 808 are formed by wavy lines. As shown, spokes 806 and 808 are spaced apart from each other at substantially regular intervals, but may also be spaced irregularly. Furthermore, each spoke 806 has substantially the same shape, but they may have different shapes, as in the case of spokes 808. Region 810 is the area in which no patterned elements are present; this area will partially constitute the iris portion of the wearer's eye and the entire pupil of the wearer, as described above.

[0109] Figure 9 Another exemplary tapered spoke pattern is shown on the contact lens 900, which is Figure 8 A variation of the pattern shown is illustrated. In this exemplary embodiment, the spoke pattern has a plurality of spokes 902 and 904, wherein spokes 902 are longer than spokes 904, and both spokes 902 and 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 the innermost radius 908 of the limbal ring 910.

[0110] Figure 10 An exemplary tapered spoke pattern is shown on a contact lens 1000, wherein a limbal ring 1002 is present and a plurality of randomly spaced spokes 1004 extend inward from the limbal ring. In this exemplary embodiment, the spokes 1004 are curved at one or more locations.

[0111] In relation to Figures 6 to 10 In all the patterns described, the spokes may extend inward to the geometric center of the lens. However, preferably, the innermost boundary of the spokes, or the edge relative to the geometric center of the lens, is located at a distance of about 6.5 mm or more from the geometric center of the lens, preferably about 7 mm or more.

[0112] In addition to the spokes and limbal ring elements, the pattern may also include any of a number of additional components. Such components may include geometric structures such as dots and lines, or unusual structures including stripes, feather-like shapes, and combinations thereof. In one exemplary embodiment, such as Figure 11As shown, the contact lens 1100 may include a plurality of random dots 1102 covering the spokes 1104 and the space between them. Alternatively, the plurality of dots may cover only a portion of the area of ​​the spokes and the space between them, such as only covering the innermost part or the part closest to the limbal ring 1106 or about one percent (1) to about ninety percent (90), preferably about twenty-five percent (25) to seventy-five percent (75) of that area. As yet another alternative, the random dot pattern may be such that the number of dots decreases as it moves inward toward the geometric center of the lens, thus creating a dot density gradient. These dots contribute to the fusion of the boundary between the limbal ring 1106 and the spokes 1104.

[0113] As another alternative, in Figure 12 The diagram illustrates a contact lens 1200 having a plurality of random dots 1202 covering the spokes 1204 and the space between them. The dots 1202 cover the entire spoke 1204 and the space between them. The spokes extend from the limbal ring 1206. The dots used in the pattern of the invention can be of any size, preferably with a diameter of about 0.060 mm to about 0.180 mm, more preferably with a diameter of about 0.0075 mm to about 0.0125 mm.

[0114] In any of the patterns described herein for cosmetic contact lenses, the center is preferably translucent to ensure no impact on visual acuity. However, the central area can be a translucent / transparent or opaque color, or any combination of opaque and translucent / transparent colors.

[0115] When used in contact lenses to enhance or alter the wearer's eye color, preferably, the limbal ring element is a solid band of color that masks the color of the limbal region of the lens wearer's eye, and more preferably, the masking color is opaque. Again, a suitably sized limbal ring can be used to create a halo effect. The remaining elements, spokes, dots, and other pattern elements can be translucent or opaque, depending on the desired cosmetic eye appearance. For the purposes of this invention, "translucent" means a color that allows an average transmittance (%T) of about 60% to about 99%, preferably about 65% to about 85%T, in the range of 380 nm to 780 nm. For the purposes of this invention, "opaque" means a color that allows an average transmittance (%T) of about 0% to about 55%, preferably about 7% to about 50%T, in the range of 380 nm to 780 nm.

[0116] The color chosen for each of the limbal ring and iris pattern elements will be determined by the natural color of the lens wearer's iris and the desired enhancement or color change. Therefore, the elements can be any color, including any of various hues and shades of blue, green, gray, brown, black, yellow, red, or combinations thereof. Preferred colors for the limbal ring include any of various hues and shades of black, brown, gray, dark blue, and dark green.

[0117] The colors of the limbal ring, spokes, and other pattern elements can also be essentially the same or complementary to each other. For example, in Figure 13 The image shows a contact lens 1300 comprising a pattern in which the limbal ring 1302 and spokes 1304 have the same color. The spokes 1306 have a different but complementary color to the limbal ring 1302 and spokes 1304. The pupil portion 1308 has a different color that is complementary to the colors of the limbal ring and spokes. Preferably, the pupil portion is translucent, meaning it is colorless.

[0118] The bright-colored elements constituting the peripheral portion can be pure white, near-white, off-white, light yellow, light blue, light pink, light green, or any combination thereof. Preferably, they are matched so as not to create a stark contrast with the visible portion of the sclera not covered by the lens. These colors are preferably obtained by using higher amounts of titanium dioxide (TiO2), thereby producing greater opacity and contrast. Pigment additions include iron oxide black, iron oxide brown, iron oxide yellow, iron oxide red, titanium dioxide, and combinations thereof, added in small amounts to adjust for whiter coloring elements. In addition to these pigments, soluble and insoluble dyes, including dichlorotriazine and vinyl sulfone dyes, can also be used. An exemplary embodiment is a colorant having 10% to 20% TiO2 and 80% to 90% light-transmitting adhesive polymer to provide suitable translucency.

[0119] Typically, coloring elements can be made from any organic or inorganic pigment suitable for contact lenses, or combinations thereof. Opacity can be controlled by varying the concentrations of the pigments and titanium dioxide used; higher concentrations produce greater opacity. Exemplary organic pigments include phthalocyanine blue, phthalocyanine green, carbazole violet, urn orange #1, and combinations thereof. Examples of useful inorganic pigments include iron oxide black, iron oxide brown, iron oxide yellow, iron oxide red, titanium dioxide, and combinations thereof. In addition to these pigments, soluble and insoluble dyes, including dichlorotriazine and vinyl sulfone dyes, can also be used. Available dyes and pigments are commercially available.

[0120] According to the present invention, contact lenses comprising a multi-layer design can be used to enhance the appearance of the eye on which the contact lens is located, while maintaining a natural appearance. Exemplary designs each comprise three layers: a unique limbal design pattern, a unique inner effect pattern, and a unique outer effect pattern. The order and color of printing the various layers affect the final design, as explained in more detail below. Furthermore, each of the three layers can be varied in color and design to create a unique appearance on the eye.

[0121] These layers can be formed using any number of design elements and principles. For example, lines can be used to define shapes and form outlines that mimic or simulate the linear structures, shapes, and contours found in natural irises. Color and hue values ​​with different levels of translucency and opacity can be used to create blending and contrast, while different colors and hues 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. Perspective in overlapping layers can be used to suggest and show depth within a given pattern. Textures formed by contrasting colors and shapes can be used to create variations in the iris. As used in the two-dimensional realm, textures are formed through the use of light and shadow features. Light and shadow elements can also be used to suggest depth and form.

[0122] As described above, this invention utilizes three distinct layers to provide greater depth and variation in the overall pattern. The limbal design pattern is the portion of the overall pattern surrounding the outer diameter of the iris and closest to the sclera, and is designed to highlight, enhance, and / or define the limbal region of the eye; however, it also includes elements extending into the iris. The inner effect pattern layer is the portion of the overall pattern designed to enhance the iris; however, it may include portions that also contribute to highlighting, enhancing, and / or defining the limbal region of the eye. The outer effect pattern layer is the portion of the overall pattern designed to enhance the iris; however, it may include portions that also contribute to highlighting, enhancing, and / or defining the limbal region of the eye. The multilayer method of this invention can be used to create different levels of transparency and / or opacity using overlapping and non-overlapping translucent layers.

[0123] As described above, various design elements can be used to achieve a variety of effects. Similar features can be used in the multilayer design according to the invention, as with the aforementioned limbal ring / conical spoke pattern. For example, spokes, fingers, hair-like structures, and similar structures and / or dots can be used to fuse a solid limbal band into the iris. Furthermore, various other geometries, including those found in natural irises, can be incorporated into various layers.

[0124] Reference Figure 14AA first exemplary embodiment of a limbal design pattern 1400 according to the present invention is shown. In this exemplary embodiment, the limbal design pattern 1400 includes a translucent annular band 1402 with a width of approximately 0.89 mm. A plurality of long, medium, and short hair-like structures 1406 are connected to the innermost boundary 1404 of the annular band 1402 and extend therefrom toward the geometric center of the limbal design pattern 1400. Some of the hair-like structures have branches 1408 that depart from the main structure 1406. Additional hair-like structures 1410 not connected to the translucent band 1402 are scattered among the other hair-like structures 1406. These hair-like structures are designed to resemble structures naturally present within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary structures, etc. A translucent annular band 1402 is designed to cover and enhance the wearer's limbal region, while equally translucent protruding structures 1406, 1408, and 1410 are designed to enhance the wearer's iris and integrate the translucent annular band 1402 with the wearer's iris. The space between the hair-like structures depends on the shape of the overlapping and underlying elements, including the tinted shape and features, and the exposed iris. The central portion 1412 of the design pattern 1400 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this central portion 1412. Furthermore, the spaces between the elements of the design can be translucent or tinted.

[0125] In this exemplary embodiment, the entire limbal design pattern 1400 is a translucent medium brown, formed from a composition comprising red iron oxide, titanium dioxide, trans-oxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in proportion to form a color in the brown to black series. It is important to note that while the limbal design pattern 1400 is translucent in this exemplary embodiment, other designs may include opaque elements, or a combination of opaque and translucent elements. This limbal design pattern 1400 is printed using techniques described in detail below, and is printed first. In other words, the first graphic layer of the overall design is incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0126] Figure 14BA first exemplary embodiment of the inner effect design pattern 1420 according to the present invention is shown. The inner effect pattern 1420 includes an annular band comprising a wavy ring structure 1422 having a geometry having: a plurality of circular grooves 1424 and peaks 1426, wherein elements of various shapes having negative spaces 1428 (the negative spaces exist as closed features within the printed elements and open shapes outside the printed elements), i.e., no pattern; and a plurality of elongated, substantially elliptical structures 1430 of different lengths and widths scattered in the grooves 1424. The substantially elliptical structures 1430 may or may not have tapered endpoints. The overall effect may resemble a sine pattern or mimic the natural iris. More specifically, the overall effect is designed to resemble structures naturally present within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The inner effect design pattern 1420 is designed to cover and enhance the wearer's iris and at least partially overlaps with the translucent annular band 1402 of the limbal design pattern 1400. Furthermore, the inner effect design pattern 1420 is overlaid on the protruding structures 1406, 1408, and 1410 of the limbal design pattern 1400 in such a way that it has overlapping translucent portions and fills some or part of the negative space between the protruding structures 1406, 1408, and 1410. The overlapping translucent pigment portions form an additional hue within the pattern, which can be darker or lighter depending on the colors used in the various structures of the underlying layer and the different levels of translucency. The space formed between the elements of the pattern depends on the shape of the overlapping and underlying elements, including the tinted shapes and features and the exposed iris. The central portion 1432 of the design pattern 1420 can be translucent because this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this area. Furthermore, the negative space can be translucent or colored.

[0127] In this exemplary embodiment, the entire inner effect design graphic 1420 is a translucent orange, formed by a composition comprising red iron oxide, trans-oxide yellow, brown iron oxide, and trans-oxide red pigment in proportion to form a color in the orange family. The orange family includes yellow and gold. These colors, or colors in this family, are intended to highlight the potential natural iris color of an individual with darker eyes, such as brown, dark brown, dark auburn, etc. For individuals with lighter eyes, different colors may be used, such as blue, green, light auburn, gray, etc. It is important to note that while the inner effect graphic 1420 includes translucent elements, in other embodiments it may include opaque elements and / or combinations of translucent and opaque elements. This inner effect graphic 1420 is printed using techniques described in detail below and is printed second, after the limbal design graphic 1400. In other words, the inner effect graphic 1420 is printed after and on top of the limbal design graphic 1400. This printing order is from a manufacturing point of view. From the observer's perspective, this layer (inner effect design graphic 1420) will appear behind graphic 1400. The outer diameter of the inner effect design graphic 1420 is smaller than the outer diameter of the limbal design graphic 1400, while the inner diameters are essentially equal.

[0128] Figure 14CA first exemplary embodiment of an external effect design pattern 1440 according to the present invention is shown. In this exemplary embodiment, the external effect design pattern 1440 includes a translucent annular band 1442 with a width of approximately 1.44 mm. Connected to and extending from the innermost boundary 1444 of the translucent annular band 1442 are a plurality of long, medium, and short substantially triangular structures 1446. Some of the substantially triangular structures contact each other at their vertices to form a closed space 1448. The external effect design pattern 1440 also includes a plurality of lines 1450, which are not connected to the translucent annular band 1442 and are scattered among the substantially triangular structures, and are oriented in the same direction; that is, towards the geometric center of the external effect design pattern 1440. These structures are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the translucent annular band 1442 includes comb-like structures 1452 that alter the appearance of the annular band 1442 to a less defined structure. The comb-like structure 1452 is designed to soften and blend the overlapping lines formed by the overlapping of translucent colors from three layers: the limbal design pattern 1400, the inner effect design pattern 1420, and the outer effect design pattern 1440. The outer effect design pattern 1440 is designed to overlay and enhance the translucent annular band 1402 of the limbal design pattern 1400, as well as the protruding structures 1406, 1408, and 1410 of the entire inner effect design pattern 1420 and the limbal design pattern 1400. The outer design pattern 1440 fills more negative space, and the overlapping portions or positive spaces form areas of additional hue, areas of different opacity levels, and distinct designs separate from any single layer or pattern. Furthermore, the negative space left between the overlapping areas forms shapes and patterns that contribute to blending and aesthetic effects by working in conjunction with the natural iris. The formation of negative space between design elements depends on the shape of the overlapping and underlying elements, including the tinted shapes and features, and the exposed iris. The central portion 1454 can be translucent because this part of the lens corresponds to the pupil. However, it is important to note that a dye can be used in this portion. Furthermore, the negative spaces between elements can be colored. The comb-like structure 1452 alters the outer diameter of the annular band 1402 of the limbal design pattern by forming the shape of the hard lines that disrupt the transparent limbal design pattern 1400.

[0129] In this exemplary embodiment, the entire outer effect design pattern 1440 is a translucent black formed from a composition comprising brown iron oxide and black iron oxide pigments. In this exemplary embodiment, where the outer effect design pattern 1440 and the limbal design pattern 1400 overlap, they form a darker, clearer / opaque area, while the non-overlapping portions of the design leave a more translucent tint, thus providing a translucent fusion from opaque to translucent. This technique allows for integration with the natural iris. In this exemplary embodiment, the outer effect design pattern 1440 includes a translucent design; however, in other embodiments, the design may include opaque elements and / or a combination of translucent and opaque elements. The outer effect pattern 1440 is printed using the technique described in detail below, and is printed third, sequentially after and above the inner effect pattern layer 1420. This printing order is from a manufacturing perspective. From an observer's point of view, this layer will appear behind the inner effect design pattern 1420. The outer diameter of the outer effect pattern 1440 is smaller than the outer diameter of the limbal design pattern 1400, while the inner diameters are substantially equal.

[0130] Figure 14D A first exemplary embodiment of a cosmetic contact lens 1460, comprising all three layers or design patterns 1400, 1420, and 1440 printed in the order described above, is shown. 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 the layers or design patterns are seen in the reverse order of printing. As shown, the overlapping layers include different colors, different levels of translucency, different hues, different levels of brightness, different levels of darkness, and patterns that form a unique structure. Variations in either the printing order or the colors will produce different designs, which will be elaborated upon later. Furthermore, changes in the translucency level can also affect the overall design regarding hue, blending, texture, and contrast.

[0131] The overall design, consisting of three layers, comprises a ring-shaped 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. The ring-shaped structure is designed to resemble the iris structure of the eye. The open or negative space at the center of the lens corresponds to the pupillary or optical zone of the eye and is preferably translucent to avoid interfering with vision. However, as mentioned above, this area can be colored and can be any negative space.

[0132] Reference Figure 15AA second exemplary embodiment of the limbal design pattern 1500 according to the present invention is shown. In this exemplary embodiment, the limbal design pattern 1500 includes a translucent annular band 1502 with a width of approximately 0.89 mm. A plurality of long, medium, and short hair-like structures 1506 are connected to the innermost boundary 1504 of the translucent annular band 1502 and extend therefrom toward the geometric center of the limbal design pattern 1500. Some of the hair-like structures have branches 1508 that depart from the main structure 1506. Additional hair-like structures 1510 not connected to the opaque band 1502 are scattered among the other hair-like structures 1506. These hair-like structures are designed to resemble structures naturally present within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary structures, etc. A translucent annular band 1502 is designed to cover and enhance the wearer's limbal region, while protruding structures 1506, 1508, and 1510 are designed to enhance the wearer's iris and integrate the annular band 1502 with the iris. Protruding structures 1506, 1508, and 1510 are also translucent. The space between the hair-like structures depends on the shape of the overlapping and underlying elements, including the tinted shape and features, and the exposed iris. The central portion 1512 of the design pattern 1500 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this central portion 1512. Furthermore, the spaces between the elements of the design can be translucent or tinted.

[0133] In this exemplary embodiment, the entire limbal design pattern 1500 is a translucent black formed from black iron oxide pigment. It is important to note that while the limbal design pattern 1500 is translucent in this exemplary embodiment, other designs may include opaque elements, or a combination of opaque and translucent elements. The limbal design pattern 1500 is printed using techniques described in detail later, and is printed first. In other words, the first graphic layer of the overall design is incorporated into the lens. The order of printing affects the overall design, as described in more detail later.

[0134] Figure 15BA second exemplary embodiment of the inner effect design pattern 1520 according to the present invention is shown. The inner effect pattern 1520 includes an annular band comprising a wavy ring structure 1522 having a geometry having: a plurality of circular grooves 1524 and peaks 1526, wherein elements of various shapes having negative spaces 1528 (the negative spaces exist as closed features within the printed elements and open shapes outside the printed elements), i.e., no pattern; and a plurality of elongated, substantially elliptical structures 1530 of different lengths and widths scattered in the grooves 1524. The substantially elliptical structures 1530 may or may not have tapered endpoints. The overall effect may resemble a radial pattern or mimic the natural iris. More specifically, the overall effect is designed to resemble structures naturally present within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The inner effect design pattern 1520 is designed to cover and enhance the wearer's iris and at least partially overlaps with the translucent annular band 1502 of the limbal design pattern 1500. Furthermore, the inner effect design pattern 1520 is overlaid on the protruding structures 1506, 1508, and 1510 of the limbal design pattern 1500 in such a way that it has overlapping translucent portions and fills some or part of the negative space between the protruding structures 1506, 1508, and 1510. The overlapping translucent pigment portions form an additional hue within the pattern, which can be darker or lighter depending on the colors used in the various structures of the underlying layer and the different levels of translucency. The space formed between the elements of the pattern depends on the shape of the overlapping and underlying elements, including the tinted shapes and features and the exposed iris. The central portion 1532 of the design pattern 1520 can be translucent because this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this area. Furthermore, the negative space between the elements of the design can be translucent or colored.

[0135] In this exemplary embodiment, the entire inner effect design pattern 1520 is a translucent medium brown, formed from a composition comprising, in proportion, red iron oxide, titanium dioxide, trans-oxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments to form a color in the gold to brown series. The colors used are intended to highlight or otherwise enhance the natural iris color of the underlying layer. Different colors are used for different colored eyes. In an alternative exemplary embodiment, the inner effect design pattern 1520 may include opaque elements and / or combinations of opaque and translucent elements. The inner effect design pattern 1520 is printed using techniques described in detail below and is printed second after the limbal design pattern 1500. In other words, the inner effect pattern 1520 is printed after and on top of the limbal design pattern 1500. This printing order is from a manufacturing point of view. From an observer's perspective, this graphic layer 1520 will appear behind the limbal design pattern 1500. The outer diameter of the inner effect design pattern 1520 is smaller than the outer diameter of the limbal design pattern 1500, while the inner diameters are substantially equal.

[0136] Figure 15CA second exemplary embodiment of the external effect design pattern 1540 according to the present invention is shown. In this exemplary embodiment, the external effect design pattern 1540 includes a translucent annular band 1542 with 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, and short substantially triangular structures 1546. Some of the substantially triangular structures contact each other at their vertices to form a closed space 1548. The outer design pattern 1540 also includes a plurality of lines 1550 that are not connected to the opaque annular band 1542 and are scattered among the substantially triangular structures, and are oriented in the same direction; that is, towards the geometric center of the external effect design pattern 1540. These structures are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the translucent annular band 1542 includes comb-like structures 1552 that alter the appearance of the annular band 1542 to a less defined structure. The comb-like structure 1552 is designed to soften and blend the overlapping lines formed by the overlapping of translucent colors from three layers: the limbal design pattern 1500, the inner effect pattern 1520, and the outer effect design pattern 1540. The outer effect design pattern 1540 is designed to overlay and enhance the translucent annular band 1502 of the limbal design pattern 1500, as well as the protruding structures 1506, 1508, and 1510 of the entire inner effect design pattern 1520 and the limbal design pattern 1500. The outer effect design pattern 1540 fills more of the negative space, and the overlapping portions or positive spaces form areas of additional hue, areas of different opacity levels, and distinct designs separate from any single layer or pattern. Furthermore, the negative spaces left between the overlapping areas form shapes and patterns that contribute to blending and aesthetic effects by working in conjunction with the natural iris. The formation of negative spaces between the elements of the design depends on the shape of the overlapping and underlying elements, including the tinted shapes and features, and the exposed iris. The central portion 1554 can be translucent, as this part of the lens corresponds to the pupil. However, it is important to note that a dye can be used in this portion. Furthermore, the negative spaces between the elements can also be translucent or colored. The comb-like structure 1552 alters the appearance of its outer diameter by softening the appearance of the annular band 1502 of the limbal design pattern.

[0137] In this exemplary embodiment, the entire external effect design pattern 1540 is a translucent gray formed from a composition comprising titanium dioxide and black iron oxide pigment. In this exemplary embodiment, where the external effect design pattern 1540 and the limbal design pattern 1500 overlap, they form a darker, clearer / opaque area, while the non-overlapping portions of the design leave a more translucent color, thus providing a translucent fusion from opaque to translucent. This technique allows for fusion with the natural iris. The external effect design pattern 1540 includes a translucent design; however, other designs may include opaque elements and / or combinations of opaque and translucent elements. The external effect pattern 1540 is printed using a technique described in detail below, and is printed third, sequentially after and above the inner effect pattern 1520. This printing order is from a manufacturing perspective. From an observer's point of view, this layer will appear behind the inner effect design pattern 1520. The outer diameter of the external effect pattern 1554 is smaller than the outer diameter of the limbal design pattern 1500, while the inner diameters are substantially equal.

[0138] Figure 15D A second exemplary embodiment of a cosmetic contact lens 1560, comprising all three layers or design patterns 1500, 1520, and 1540 printed in the order described above, is shown. While the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the layers or design patterns are seen in the reverse order of printing. Overlapping layers include different colors, different hues, different brightness levels, different darkness levels, and patterns that form unique structures. Variations in either the printing order or the colors will produce different designs. Furthermore, any of these variations can affect the level of translucency, which can also affect the overall design.

[0139] The overall design, consisting of three layers, comprises a ring-shaped 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. The ring-shaped structure is designed to resemble the iris structure of the eye. The open or negative space at the center of the lens corresponds to the pupillary region or optical zone of the eye and is preferably translucent to avoid interfering with vision. However, as mentioned above, this region, and any negative space, can be colored.

[0140] Reference Figure 16AA third exemplary embodiment of the limbal design pattern 1600 according to the present invention is shown. In this exemplary embodiment, the limbal design pattern 1600 includes a translucent annular band 1602 with a width of approximately 0.89 mm. Connected to the innermost boundary 1604 of the translucent annular band 1602 and extending therefrom toward the geometric center of the limbal design pattern 1600 are a plurality of long, medium, and short hair-like structures 1606. Some of the hair-like structures have branches 1608 that depart from the main structure 1606. Additional branch-like structures 1610 forming hook-like structures are designed to mimic the edge of the pupillary muscle. As previously described, all these structures are designed to resemble structures naturally present within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary structures, etc. A translucent annular band 1602 is designed to cover and enhance the wearer's limbal region, while protruding structures 1606, 1608, and 1610 are designed to enhance the wearer's iris and integrate the translucent annular band 1602 with the iris. The hair-like structures are also translucent. The space between the hair-like structures depends on the shape of the overlapping and underlying elements, including the tinted shape and features, and the exposed iris. The central portion 1612 of the design pattern 1600 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this central portion 1612. Furthermore, the spaces between the elements of the design can be translucent or tinted.

[0141] In this exemplary embodiment, the entire limbal design pattern 1600 is a translucent dark brown, formed from a composition comprising brown and black iron oxide pigments in proportion to form a color in the brown to black range. The limbal design pattern 1600 includes translucent elements; however, in other exemplary embodiments, the limbal design pattern may include opaque elements and / or a combination of opaque and translucent elements. The limbal design pattern 1600 is printed using techniques described in detail below, and is printed first. In other words, a first graphic design of the overall design is incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0142] Figure 16BA third exemplary embodiment of the external effect design pattern 1620 according to the present invention is shown. It is important to note that in this exemplary embodiment, the printing order of the inner and outer effect patterns is changed. In the above exemplary embodiment, the inner effect design pattern is located between the limbal design pattern and the outer effect design pattern. In this exemplary embodiment, the outer effect design pattern 1620 includes a translucent annular band 1622 with a width of approximately 1.44 mm. Connected to and extending from the innermost boundary 1624 of the translucent annular band 1622 are a plurality of long, medium, and short substantially triangular structures 1626. Some of the substantially triangular structures contact each other at their vertices to form a closed space 1628. The outer effect design pattern 1620 also includes a plurality of lines 1630 that are not connected to the translucent annular band 1622 and are distributed among the substantially triangular structures, and are oriented in the same direction; that is, towards the geometric center of the outer effect design pattern 1620. Some of the substantially triangular structures or protrusions 1626 in the substantially triangular structure have branches 1632, and some of the lines 1630 have branches 1634. All these structures are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the annular band 1622 includes a comb-like structure 1636 that alters the appearance of the annular band 1622 to a less distinct structure. The comb-like structure 1636 is designed to soften and blend the overlapping lines formed by overlapping translucent colors from two layers. All elements of the outer effect design pattern 1620 are translucent; however, in other embodiments, elements may be opaque and / or a combination of translucent and opaque. The outer effect design pattern 1620 is designed to overlay and enhance the translucent annular band 1602 of the limbal design pattern 1600. Furthermore, the external effect design graphic 1620 is overlaid on the protruding structures 1606, 1608, and 1610 of the limbal design graphic 1600 in such a way that it has overlapping portions and fills some or part of the negative space between the protruding structures 1606, 1608, and 1610. The external effect design graphic 1620 fills more of the negative space, and the overlapping portions or positive spaces form areas of additional hue, areas of different opacity levels, and different designs that are separate from and distinct from any single layer. Furthermore, the negative spaces left between the overlapping areas form shapes and patterns that contribute to blending and cosmetic effects by working in conjunction with the natural iris. The formation of negative spaces between the elements of the design depends on the shape of the overlapping and underlying elements, including the tinted shapes and features and the exposed iris. The central portion 1638 can be translucent because this position of the lens corresponds to the pupil. However, it is important to note that the dye can be used in this area. Additionally, the dye can also be used in the negative spaces.The comb-like structure 1636 alters the outer diameter by softening the appearance of the annular band 1602 of the limbal design pattern 1600.

[0143] In this exemplary embodiment, the entire external effect design graphic 1620 is a translucent brown formed from a composition comprising red iron oxide, titanium dioxide, trans-oxide yellow, phthalocyanine green, yellow iron oxide, brown iron oxide, and black iron oxide pigments. In this exemplary embodiment, where the external effect design graphic 1620 and the limbal design graphic 1600 overlap, they form a darker, clearer / opaque area, while the non-overlapping portions of the design leave a more translucent color, thus providing a translucent fusion from opaque to translucent. This technique allows for integration with the natural iris. In this exemplary embodiment, the external 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 external effect design graphic 1620 is printed using techniques described in detail below, and is a second print after and on top of the limbal effect graphic layer 1600. This printing order is from a manufacturing perspective. From an observer's point of view, this layer or graphic will appear behind the limbal design graphic 1600. The outer diameter of the external effect graphic 1620 is smaller than that of the limbal design graphic 1600, while the inner diameters are essentially equal.

[0144] Figure 16CA third exemplary embodiment of the inner effect design pattern 1640 according to the present invention is shown. In this exemplary embodiment, the inner effect design pattern 1640 includes a translucent annular band 1642 with a width of approximately 2.08 mm. As can be readily seen from the illustration, in this embodiment, the annular band 1642 is much wider than other annular bands. Connected to and extending from the innermost boundary 1644 of the annular band 1642 are a plurality of generally triangular structures or protrusions 1646 extending inward toward the geometric center of the inner effect design pattern 1640. These protrusions are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the annular band 1642 includes an inconsistent surface 1648 to soften / blend areas of hard-line overlap, which alters the appearance of the annular band 1642 to a less defined structure. This is less pronounced than the comb-like structure 1636 of the outer effect design pattern 1620. The inner effect design pattern 1640 is designed to overlay and enhance the translucent annular bands 1602 and 1622 of the limbal design pattern 1600 and the outer effect design pattern 1620, respectively. Again, the essentially triangular structure 1646 overlaps and fills the spaces between the protrusions 1606, 1608, and 1610 of the limbal design pattern 1600 and the elements 1626, 1628, and 1630 of the outer design pattern 1620. The overlapping translucent pigment portions create additional hues within the pattern, which can be darker or lighter depending on the colors used in the various underlying structures and the different levels of translucency. The spaces between the elements of the pattern are formed depending on the shape of the overlapping and underlying elements, including the tinted shapes and features, and the exposed iris. The central portion 1650 of the inner effect pattern 1640 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in the central portion 1650 as well as in the negative space.

[0145] In this exemplary embodiment, the entire inner effect design graphic 1640 is a translucent yellow, formed from a composition comprising trans-iron oxide yellow, yellow iron oxide, brown iron oxide, and trans-iron oxide red pigments in proportion to form a color in the yellow family. As mentioned above, yellow is part of an orange family that also includes gold. These colors are intended to highlight the potential natural iris color of individuals with brown or dark eyes. Different colors will be used for lighter eye colors. The inner effect design graphic 1640 is printed using techniques described in detail below and is printed third in sequence after the outer effect graphic 1620. In other words, the inner effect graphic 1640 is printed after and on top of the outer design graphic 1620. This printing order is from a manufacturing point of view. From an observer's perspective, this layer will appear behind the other layers. The inner effect design graphic 1640 includes translucent elements, but 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 limbal design graphic 1600, while the inner diameters are substantially equal.

[0146] Figure 16D A third exemplary embodiment of a cosmetic contact lens 1660, comprising all three layers or design patterns 1600, 1620, and 1640 printed in the order described above, is shown. 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. Furthermore, all three design patterns have annular bands forming a unique limbal ring design pattern. Although the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the visual effect is that the layers or design patterns are seen in the reverse order of the printing. Overlapping layers include different colors, different hues, different brightness levels, different darkness levels, and patterns that form a unique structure. Variations in either the printing order or the colors will produce different designs. Furthermore, variations in translucency can also be achieved.

[0147] The overall design, consisting of three layers, comprises a ring-shaped 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 ring-shaped structure is designed to resemble the iris structure of the eye. The open or negative space at the center of the lens corresponds to the pupillary region or optical zone of the eye and is preferably translucent so as not to interfere with vision. However, as mentioned above, this region can be colored because it can be a negative space between elements.

[0148] Reference Figure 17AA fourth exemplary embodiment of the limbal design pattern 1700 according to the present invention is shown. In this exemplary embodiment, the limbal design pattern 1700 includes a translucent annular band 1702 with a width of approximately 0.85 mm. Attached to the innermost boundary 1704 of the translucent annular band 1702 and extending therefrom toward the geometric center of the limbal design pattern 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 pattern 1700 but are not attached to the translucent annular band 1702. A crypt is a physical feature found on the natural iris, which is a series of openings located on either side of the ciliary area. A crypt on the basal part of the iris is an additional opening that can be observed at the outermost part of the ciliary portion near the iris. As described above, all elements in the design pattern are designed to resemble structures naturally present within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. A translucent annular band 1702 is designed to cover and enhance the wearer's limbal region, while protruding structures 1706 and 1708 are designed to enhance the wearer's iris and integrate the annular band 1702 with the iris. The space between the geometric structures depends on the shape of the overlapping and underlying elements, including the tinted shape and features, as well as the exposed iris. The central portion 1710 of the design pattern 1700 can be translucent, as this portion of the area corresponds to the pupil. However, it is important to note that the dye can be used in this central portion 1710. Furthermore, the dye can be used in the spaces between the elements.

[0149] In this exemplary embodiment, the entire limbal design graphic 1700 is a translucent dark brown, formed from a composition comprising brown and black iron oxide pigments in proportion to form a color in the brown to black range. Although the limbal design graphic is translucent, in other exemplary embodiments, it may include opaque elements and / or combinations of opaque and translucent elements. The limbal design graphic 1700 is printed using techniques described in detail below, and is printed first. In other words, a first graphic design of the overall design is incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0150] Figure 17BA fourth exemplary embodiment of the external effect design pattern 1720 according to the present invention is shown. It is important to note that in this exemplary embodiment, the printing order of the inner and outer effect patterns is changed compared to the previous two exemplary embodiments. In this exemplary embodiment, the external effect design pattern 1720 includes a translucent annular band 1722 with a width of approximately 0.89 mm. Connected to and extending from the innermost boundary 1724 of the translucent annular band 1722 are a plurality of long, medium, and short substantially triangular structures 1726. Some of the substantially triangular structures contact each other at their vertices to form a closed space 1728. The external effect design pattern 1720 also includes a plurality of lines 1730 that are not connected to the translucent annular band 1722 and are distributed among the substantially triangular structures, and are oriented in the same direction; that is, towards the geometric center of the external effect design pattern 1720. Some of the substantially triangular structures or protrusions 1726 have branches 1732, and some of the lines 1730 have branches 1734. All these structures are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the annular band 1722 includes a comb-like structure 1736 that alters the appearance of the transparent annular band 1722 to a less defined structure. The comb-like structure 1736 is designed to soften and blend overlapping lines formed by overlapping translucent colors from other layers. The outer effect design graphic 1720 is designed to overlay and enhance the translucent annular band 1702 of the limbal design graphic 1700. Furthermore, the outer effect design graphic 1720 overlays the protruding structures 1706 and 1708 of the limbal design graphic 1700 in such a way that it has overlapping portions and fills some or part of the negative space between the protruding structures 1706 and 1708. The outer effect design graphic 1720 fills more of the negative space, and the overlapping portions or positive spaces form areas of additional hue, areas of different opacity levels, and different designs that are separate from and distinct from any single layer. Furthermore, the negative space left between the overlapping areas forms shapes and patterns that contribute to fusion and aesthetic effects by working in conjunction with the natural iris. The formation of the negative space between the design elements depends on the shape of the overlapping and underlying elements; including the tinted shape and features as well as the exposed iris. The central portion 1738 can be translucent because this part of the lens corresponds to the pupil. However, it is important to note that the tint can be used. Additionally, the tint can be used in the negative space of the design. The comb-like structure 1736 alters its outer diameter by softening the appearance of the annular band 1702 of the limbal design pattern 1700.

[0151] In this exemplary embodiment, the entire external effect design graphic 1720 is a translucent brown, formed from a composition comprising red iron oxide, titanium dioxide, trans-oxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments in proportion to form a color in the brown to black series. In this exemplary embodiment, where the external effect design graphic 1720 and the limbal design graphic 1700 overlap, they form a darker, clearer / opaque area, while the non-overlapping portions of the design have a more translucent color, thus providing a translucent blend from opaque to translucent. This technique allows for integration with the natural iris. The external effect design graphic 1720 includes translucent elements, but in other embodiments may include opaque elements and combinations of translucent and opaque elements. Furthermore, the effect graphic 1720 is printed using techniques described in detail below, and is printed second, sequentially after and on top of the limbal effect graphic layer 1700. This printing order is from a manufacturing point of view. From the observer's perspective, this layer or graphic will be behind the limbal layer 1700. The outer diameter of the external effect graphic 1720 is smaller than that of the limbal design graphic 1700, while the inner diameters are essentially equal.

[0152] Figure 17CA fourth exemplary embodiment of the inner effect design pattern 1740 according to the present invention is shown. In this exemplary embodiment, the inner effect design pattern 1740 includes a translucent annular band 1742 with a width of approximately 2.03 mm. As can be readily seen from this illustration, in this exemplary embodiment, the annular band 1742 is much wider than other annular bands. Connected to and extending from the innermost boundary 1744 of the translucent annular band 1742 are a plurality of generally triangular structures or protrusions 1746 extending inward toward the geometric center of the inner effect design pattern 1740. These protrusions are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the annular band 1742 includes an inconsistent surface 1748 to soften / blend areas of hard-line overlap, which alters the appearance of the translucent annular band 1742 to a less defined structure. This is less pronounced than the comb-like structure 1736 of the outer effect design pattern 1720. The inner effect design pattern 1740 is designed to overlay and enhance the translucent annular bands 1702 and 1722 of the limbal design pattern 1700 and the outer effect design pattern 1720, respectively. Again, the essentially triangular structure 1746 overlaps and fills the space between the protrusions 1706 and 1708 of the limbal design pattern 1700 and the elements 1726, 1728, and 1730 of the outer design pattern 1720. The overlapping translucent pigment portions create additional hues within the pattern, which can be darker or lighter depending on the colors used in the various underlying structures and the different levels of translucency. The space between the elements of the pattern is formed depending on the shape of the overlapping and underlying elements, including the tinted shapes and features, and the exposed iris. The central portion 1750 of the inner effect pattern 1740 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this area or zone, as well as in the negative space of the design.

[0153] In this exemplary embodiment, the entire inner effect design graphic 1740 is a translucent brown, formed from a composition comprising, in proportion, red iron oxide, phthalocyanine blue, titanium dioxide, trans-oxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments to form a color in the brown to black series. This inner effect design graphic 1740 is printed using techniques described in detail below, and is printed third in sequence after the outer effect graphic 1720. In other words, the inner effect design graphic 1740 is printed after and on top of the outer design graphic 1720. The printing order is from a manufacturing perspective. From an observer's point of view, this layer or graphic will appear behind other layers or graphics. The inner effect design graphic 1740 includes translucent elements, but may also include opaque elements and / or combinations of opaque and translucent elements. The outer diameter of the inner effect design graphic 1740 is smaller than the outer diameter of the limbal design graphic 1700, while the inner diameters are substantially equal.

[0154] Figure 17D A fourth exemplary embodiment of a cosmetic contact lens 1760, comprising all three layers or design patterns 1700, 1720, and 1740 printed in the order described above, is shown. 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, as in the previous exemplary embodiments. Furthermore, all three design patterns have annular bands forming a unique limbal ring design pattern. Although the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the design patterns are seen in the reverse order. The overlapping layers include different colors, different hues, different brightness levels, and different darkness levels, as well as patterns that form a unique structure. Variations in either the printing order or the colors will produce different designs. Variations in translucency can also be achieved.

[0155] The overall design, formed by three layers, includes a ring-shaped structure with an inner diameter ranging from approximately 6.4 mm to approximately 6.6 mm and an outer diameter ranging from approximately 12.70 mm to approximately 12.775 mm. This ring-shaped structure is designed to resemble the iris structure of the eye. The open or negative space at the center of the lens corresponds to the pupillary area or optical zone of the eye and is preferably translucent so as not to interfere with vision. However, as mentioned above, this area can be colored, as it can be a negative space between elements of the design.

[0156] Reference Figure 18AA fifth exemplary embodiment of the limbal design pattern 1800 according to the present invention is shown. In this exemplary embodiment, the limbal design pattern 1800 includes a translucent annular band 1802 with a width of approximately 1.15 mm. Attached to the innermost boundary 1804 of the translucent annular band 1802 and extending therefrom toward the geometric center of the limbal design pattern 1800 are a plurality of long, medium, and short hair-like structures 1806. Additional hair-like structures 1808 not attached to the translucent annular band 1802 are scattered among the other hair-like structures 1806. Additional structures 1810 are free-form geometries that may resemble circles, squares, triangles, and any combination thereof. These shapes may contact or be independent of each other and overlay and occupy the space between the hair-like structures 1806 and 1808. All these structures are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary structures, etc. A translucent annular band 1802 is designed to cover and enhance the wearer's limbal region, while protruding structures 1806, 1808, and 1810 are designed to enhance the wearer's iris and integrate the translucent annular band 1802 with the wearer's iris. The space between the hair-like structures depends on the shape of the overlapping and underlying elements, including the tinting shape and features, as well as the exposed iris. The central portion 1812 of the limbal design pattern 1800 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this central portion. Furthermore, the dye can be used in the negative spaces between the design elements.

[0157] In this exemplary embodiment, the entire limbal design pattern 1800 is a transparent black formed from black iron oxide pigment. In other embodiments, the limbal design pattern may include opaque elements and / or a combination of opaque and translucent elements. The limbal design pattern 1800 is printed using techniques described in detail below, and is printed first. In other words, the first graphic layer of the overall design is incorporated into the lens. The order of printing affects the overall design, as described in more detail below.

[0158] Figure 18BA fifth exemplary embodiment of the inner effect design pattern 1820 according to the present invention is shown. The inner effect pattern 1820 includes annular bands of long, medium, and short dotted / dashed lines 1822 that are generally oriented toward the geometric center of the inner effect pattern 1820. The overall effect is designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial sulci, crypts, ciliary structures, etc. In this exemplary embodiment, the inner effect design pattern 1820 is used to provide subtle enhancements that retain translucency and / or color in a given area while suggesting directional lines that may be found in the radial sulci or ciliary areas of a natural iris. This subtle enhancement is also used to impart small highlights. The inner effect design pattern 1820 is designed to overlay and enhance the wearer's iris and at least partially overlaps with the translucent annular band 1802 of the limbal design pattern 1800. Furthermore, the inner effect design pattern 1820 is overlaid on the protruding structures 1806, 1808, and 1810 of the limbal design pattern 1800 in such a way that it has overlapping opaque portions and fills some or part of the negative space between the protruding structures 1806, 1808, and 1810. The overlapping portions will have a different color and a different level of translucency than the respective underlying structures. Furthermore, the overlapping area can be darker or lighter, depending on the colors used in the respective underlying structures. The spatial formation between the elements of the pattern depends on the shape of the overlapping and underlying elements, including the tinted shapes and features, and the exposed iris. The central portion 1824 of the design pattern 1820 can be translucent, as this portion of the design corresponds to the pupil. However, it is important to note that the dye can be used in this area and in the negative space between the design elements.

[0159] In this exemplary embodiment, the entire inner effect design graphic 1820 is a transparent orange, formed from a composition comprising, in proportion, red iron oxide, trans-oxide yellow, yellow iron oxide, brown iron oxide, and trans-oxide red pigment to form a color within the orange family. The orange family includes yellow and gold. These colors, or colors within this family, are intended to highlight the potential natural iris color of individuals with brown or dark eyes. Different colors will be used for individuals with light-colored eyes. In an alternative embodiment, the inner effect graphic 1820 may include opaque elements and / or a combination of opaque and translucent elements. This inner effect graphic 1820 is printed using techniques described in detail below and is printed second, sequentially, after the limbal design graphic 1800. In other words, the inner effect graphic 1820 is printed after and on top of the limbal design graphic 1800. This printing order is from a manufacturing perspective. From an observer's point of view, this layer will appear behind graphic 1800. The outer diameter of the inner effect design graphic 1820 is smaller than the outer diameter of the limbal design graphic 1800, while the inner diameters are substantially equal.

[0160] Figure 18C A fifth exemplary embodiment of the external effect design pattern 1840 according to the present invention is shown. In this exemplary embodiment, the external effect design pattern 1840 includes a translucent annular band 1842 with 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, and short substantially triangular structures 1846. Some of the substantially triangular structures contact each other at their vertices to form a closed space 1848. The external effect design pattern 1840 also includes a plurality of lines 1850, which are not connected to the translucent annular band 1842 and are scattered among the substantially triangular structures, and are oriented in the same direction; that is, towards the geometric center of the external effect design pattern 1840. These structures are designed to resemble naturally occurring structures within the iris, such as pupillary muscle structures, folds or radial grooves, crypts, ciliary structures, etc. The outer periphery of the annular band 1842 includes comb-like structures 1852 that alter the appearance of the translucent annular band 1842 to a less defined structure. The comb-like structure 1852 is designed to soften and blend the overlapping lines formed by the overlapping of translucent colors from the three layers. The outer effect design pattern 1840 is designed to overlay and enhance the translucent ring band 1802 of the limbal design pattern 1800, as well as the prominent structures 1806, 1808, and 1810 of the entire inner effect design pattern 1820 and the limbal design pattern 1800. The outer design pattern 1840 fills more of the negative space, and the overlapping portions or positive spaces form areas of additional hue, different opacity levels, and distinct designs separate from any single layer. Furthermore, the negative spaces left between the overlapping areas form shapes and patterns that contribute to blending and cosmetic effects by working in conjunction with the natural iris. The formation of negative spaces between the design elements depends on the shape of the overlapping and underlying elements, including the tinted shape and features, and the exposed iris. The central portion 1854 can be translucent, as this part of the lens corresponds to the pupil. However, it is important to note that the dye can be utilized. The comb-like structure 1852 alters the outer diameter of the translucent annular band 1802 of the limbal design pattern by forming the shape of the hard lines that disrupt the limbal design pattern 1800.

[0161] In this exemplary embodiment, the entire outer effect design pattern 1840 is a translucent brown, formed from a composition comprising red iron oxide, titanium dioxide, trans-oxide yellow, yellow iron oxide, brown iron oxide, and black iron oxide pigments to form a series or color range from brown to black. In this exemplary embodiment, where the outer effect design pattern 1840 and the limbal design pattern 1800 overlap, they form a darker, clearer / opaque area, while the non-overlapping parts of the design leave a more translucent color, thus providing a translucent blend from opaque to translucent. This technique allows for integration with the natural iris. Furthermore, the effect pattern 1840 is printed using techniques described in detail below, and is printed third, sequentially after and above the inner effect pattern layer 1820. This printing order is from a manufacturing point of view. From the observer's perspective, this layer will appear behind the inner design pattern 1820. The outer diameter of the outer effect pattern 1840 is smaller than the outer diameter of the limbal design pattern 1800, while the inner diameters are substantially equal.

[0162] Figure 18D A fifth exemplary embodiment of a cosmetic contact lens 1860, comprising all three layers or design patterns 1800, 1820, and 1840 printed in the order described above, is shown. The printing order returns again to the limbus, inner effect pattern, and outer effect pattern, as in the previous two exemplary embodiments. Although the printing order is described from a manufacturing perspective, when an observer views the contact lens on the eye, the layers or design patterns are seen in the reverse order of the printing described. As shown, the overlapping layers include different colors, hues, brightness, darkness, and patterns that form unique structures. Variations in either the printing order or the colors will produce different designs, which will be elaborated upon later. Variations in translucency can also be achieved.

[0163] The overall design, consisting of three layers, comprises a ring-shaped structure with an inner diameter ranging from approximately 6.7 mm to approximately 7.1 mm and an outer diameter ranging from approximately 12.675 mm to approximately 12.750 mm. This ring-shaped design is designed to resemble the structure of the iris of the eye. The open or negative space at the center of the lens corresponds to the pupillary region or optical zone of the eye and is preferably light-transmitting so as not to interfere with vision. However, dyes may be used in this region and in the negative spaces between the design elements.

[0164] The exemplary embodiments described above relate to contact lenses with multi-layered designs that can enhance and / or highlight the appearance of the eye upon which the contact lens rests, while maintaining a natural look. These exemplary designs each comprise three layers: a unique limbal design graphic, a unique inner effect graphic, and a unique outer effect graphic. These layers can be formed using any number of design elements and design principles. For example, lines can be used to define shapes and form contours that mimic or simulate the linear structures, shapes, and outlines found in natural irises. Color and hue values ​​with different levels of translucency and opacity can be used to create blending and contrast, while different colors and hues 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's effect. Perspective in overlapping layers can be used to suggest and display depth within a given pattern. Texture can be used to create variations in the iris. As used in the two-dimensional realm, texture is formed through the use of light and shadow. Light and shadow elements can also be used to suggest depth and form.

[0165] As described above, this invention utilizes three distinct layers to provide greater depth and variation in the overall pattern. The limbal design pattern is the portion of the overall pattern surrounding the outer diameter of the iris and closest to the sclera, and is designed to highlight, enhance, and / or define the limbal region of the eye; however, it also includes elements extending into the iris. The inner effect pattern layer is the portion of the overall pattern designed to enhance the iris; however, it may include portions that also contribute to highlighting, enhancing, and / or defining the limbal region of the eye. The outer effect pattern layer is the portion of the overall pattern designed to enhance the iris; however, it may include portions that also contribute to highlighting, enhancing, and / or defining the limbal region of the eye. The multilayer method of this invention can be used to create different levels of transparency and / or opacity using overlapping and non-overlapping translucent layers.

[0166] While the exemplary embodiments described above illustrate various design features that can be used in cosmetic contact lenses, it is important to note that various combinations and sub-combinations of elements / features can be utilized to form new designs. Changes in the printing order can affect the overall design. Changes in any single color within at least one layer can affect the overall design. Changes in the design within any single layer can affect the overall design, and changes in any feature of any design within any single layer can affect the overall design. Changes in the size of any design and / or the degree of overlap between layers can affect the overall design. Changes in the amount of negative / positive space within any single layer or in each layer can affect the overall design. Changes in the translucency of any or all layers can affect the overall design. Furthermore, additional layers can also affect the overall design. The exemplary embodiments described above illustrate different designs that can be achieved using the various design elements described herein.

[0167] Although many terms are used throughout this instruction manual, all designs described herein are intended to enhance the appearance of the wearer's eyes. Therefore, as used herein, the term "enhancement" should include any effect that emphasizes, highlights, defines, distinguishes, improves, strengthens, magnifies, enlarges, reinforces, and / or cosmetically alters the appearance of the wearer's eyes.

[0168] It is important to note that all color formulations described herein and in connection with this invention are generally described in terms of pigment content and are typically categorized as specific colors. It is also important to note that any suitable color can be used in implementing this invention.

[0169] Based on market research, designs / patterns / colors for different areas of the cosmetic contact lens are developed. These patterns are then etched into a metal structure commonly referred to as a pad printing plate. More specifically, a metal plate, preferably made of steel and more preferably stainless steel, is coated with a photoresist material that becomes insoluble in water once cured. A pattern is selected or designed and then scaled down to the desired size using any of a variety of suitable techniques (such as photolithography), placed on the metal plate, and the photoresist material is cured. The metal plate or pad printing plate is then washed with an aqueous solution, and the resulting image or pattern is etched into the metal plate to a suitable depth, for example, about twenty (20) micrometers. Once the pad printing plate is made, the cosmetic contact lens is manufactured using a multi-step process as described below.

[0170] Figure 19 A general overview of the pad printing process used in the manufacturing process is shown. The first step 1902 of this process is to fill the pad printing plate cavities with the desired colorant. The pad printing plate 1901 includes a plurality of pad printing plate cavities 1903 in which a specific pattern is etched. The second step 1904 of this process involves removing excess ink or colorant from the surface of the pad printing plate 1901. Excess ink is typically removed from the surface of the pad printing plate 1901 using one or more scrapers on a cover 1905. In the third step 1906 of this process, the colorant is dried on the pad printing plate 1901. In the fourth step 1908 of this process, the colorant in the pad printing plate 1901 is absorbed by a pad. In the fifth step 1910 of this process, the colorant is dried or dried on the pad. In the sixth step 1912 of this process, the colorant is transferred from the pad to the front curved surface, wherein additional treatment is performed as described below. In the seventh step 1914 of this process, the colorant is dried or dried on the front curved surface of the front curved half-mold. Then repeat the process for the remaining two effect layers.

[0171] Figure 20A more detailed process description is provided. In the first step 2002, an unprinted front surface mold for contacting the lens is provided. In the second step 2004, a light-transmitting base material (i.e., without pigment or dye) is applied to the front surface. The light-transmitting base material depends on the lens material to be used, as described in more detail below. In the third step 2006, an ink comprising solvent, light-transmitting base material, and pigment is applied to the front surface printed with the light-transmitting base material. This step is repeated again, such that all three layers are applied to the base surface printed with the light-transmitting base material. In the fourth step 2008, a reactive monomer mixture, such as etafilcon-A, is then metered into the printed front surface. In the fifth step 2010 of the process, a back surface mold for contacting the lens is positioned on the front surface mold and held on the front surface mold for two (2) minutes while maintaining the temperature at seventy (70) °C. In the sixth step 2012 of the process, the reactive monomer mixture between the front and back surfaces is exposed to visible light for curing. This curing step is performed at 70°C using 5mW of visible light for 4 (4) minutes. In step 7, 2014 of this process, the contact lens from the mold is hydrated for 1 (1) hour in a 70°C solution of 800ppm Tween 80 and deionized water, and then rehydrated for 1 (1) hour in 45°C deionized water. In step 8, 2016 of this process, the contact lens is steam-sterilized for 18 (18) minutes in its own packaged saline solution at 124°C. It is important to note that the above process has been simplified for ease of explanation.

[0172] As described above, the lens forming material contains etafilcon A. Etafilcon A is a well-known and patented material used in the manufacture of contact lenses. Etafilcon A is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with 1,1,1-trimethylolpropane trimethacrylate and ethylene glycol dimethacrylate. Etafilcon A is available from Johnson & Johnson Vision Care, Inc. In many contact lenses obtained. It is important to note that although Etafilcon A is used in the exemplary embodiments described herein, any suitable lens-forming material can be used. For Etafilcon A, the preferred adhesive polymer is a random block copolymer of HEMA and MAA or a homopolymer of HEMA. Based on the total weight of the adhesive polymer, the weight percentage of each component in these embodiments is from about 93% to about 100% by weight of HEMA and from about 0% to about 2% by weight of MAA.

[0173] Using the methods described above or similar methods, the pigments are encapsulated within the light-transmitting base material and the body material that forms the lens. In other words, all the colored layers are encapsulated within the lens material and never come into contact with the eye.

[0174] Figure 21 The basic structure of a cosmetic contact lens formed by the method described above is shown. One or more effect layers 2104 are sandwiched or encapsulated between the translucent substrate 2102 and the body lens material 2106. Although only a single effect layer is shown, any number of effect layers or printed coloring layers can be encapsulated between other two layers. As shown, the contact lens includes a complete translucent substrate layer to encapsulate one or more colored printed layers within the lens material, even if the one or more colored printed layers have a substantially annular structure. Even with spokes, no colored design extends into the optical area of ​​the lens. In other words, with this design, the central lens area or central lens region of the contact lens is covered by the translucent substrate material. To maintain precise optical surfaces and paths and thus provide optimal vision, safety, and comfort for the patient, in contrast to the complete coverage described in step 2004 above, the translucent substrate material can be removed from the central optical area by printing a translucent annular band on the anterior curved surface using an annular pattern printing plate. The size of the translucent annular band can be designed to encapsulate or cover any designed layer. More specifically, by properly determining the size of the pad printing plate, the opening in the annular structure can be optimized to maintain optical quality while ensuring the encapsulation of the colored printing layers. Since no design should extend into the optical area, there is no need to encapsulate anything in that area.

[0175] It is important to note that any number of terms can be used to describe the enclosed colored area as described in this invention. For example, the colored layer can be referred to as an effect layer, a printing layer, a design layer, and a colored printing layer.

[0176] Figure 22 , Figure 22A and Figure 22B An exemplary embodiment of a pad printing plate 2200 that can be utilized according to the present invention is shown. In this exemplary embodiment, the pad printing plate 2200 is used to deposit a translucent base material in a substantially annular pattern onto a front-curved mold. In this exemplary embodiment, the base coating material is first treated with the process described above regarding ink deposition. In other words, the above-described process regarding... Figure 19 and Figure 20The process first involves depositing a translucent base coating material onto a front-curved mold. The deposition location allows for the encapsulation of pigments of any suitable design, while ensuring that the central optical area—that is, the area corresponding to the pupil region of the eye—remains free of any translucent base coating material. The improved translucent base printing plate 2200 eliminates the presence of translucent base coating material in the optical area while covering any colored design, or eliminates the presence of translucent base coating material while covering all remaining portions of the contact lens front. In other words, the translucent base can extend beyond the design, reaching the edge of the lens. The printing plate 2200 includes a first annular portion 2202, a transition portion 2206, and an optical area opening 2204. The first annular portion 2202 can extend from a location corresponding to the edge of the contact lens or from any point inserted from the lens edge, which corresponds to a location close to the colored design. According to an exemplary embodiment of the invention, the first annular portion 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 portion 2202 has an inner diameter of approximately 6 mm and an outer diameter of approximately 13.5 mm. The first annular portion 2202 is a portion of the pad printing plate 2200 that picks up the light-transmitting base material for transfer to the pad. The transition portion 2206 is a much smaller annular band extending from the inner diameter of the first annular portion 2202 to the outer diameter of the optical region opening 2204. According to an exemplary embodiment of the invention, the transition portion 2206 has an inner diameter of approximately 1.9 mm and an outer diameter of approximately 8 mm. In a preferred embodiment, the transition portion 2206 has an inner diameter of approximately 4.4 mm and an outer diameter of approximately 6 mm. The transition portion 2206 is configured to retain a reduced amount of light-transmitting base coating material as it approaches the optical region opening 2204, and this can be achieved in a variety of different ways as detailed herein. As shown, the transition portion 2206 includes a jitter pattern or matrix that picks up a certain amount of base coating material for deposition on the front curved die. The transition portion or region 2206 serves to better fuse or combine the two materials. More specifically, the transition portion 2206 of the base coating material to be transferred, with its pattern / matrix and reduced amount, provides better fusion / bonding of the light-transmitting base coating material and the lens monomer, thereby reducing any induced stress that might occur without the transition portion 2206. In an exemplary embodiment, the transition portion 2206 has a thickness of approximately 30 micrometers near the first annular portion 2202 and approximately 0 micrometers near the optical region opening 2204. In a preferred embodiment, the transition portion 2206 has a thickness of approximately 20 micrometers near the first annular portion 2202 and approximately 10 micrometers near the optical region opening 2204. However, after pad printing, a reactive monomer mixture is metered into the printed front surface, and a back surface mold is positioned on top of the front surface mold to form a lens as detailed above, without changing the lens thickness.

[0177] It is important to note that any suitable method or technique can be used for encapsulation coloring design, as long as no base coating material is deposited in the central optical area, but only the lens element itself is deposited. Furthermore, it is important to note that the dimensions of the translucent base coating material to be transferred from the pad printing plate 2200 are based on factors such as pad geometry and hardness, and ultimately on lens expansion and measurement techniques.

[0178] The exemplary transition portion 2206 described above includes Figure 22A The exploded diagram shows the pattern / matrix in detail and in Figure 22B The thickness gradient is shown in detail in the exploded cross-sectional view. However, other exemplary transition portions may include only one or the other, rather than the combination described above. Specifically, in an alternative exemplary embodiment, the transition portion may consist only of a pattern / matrix, where a reduction in pattern density serves to reduce the material thickness, thereby causing a reduction in potential induced stress. In another alternative exemplary embodiment, a reduced amount of solid layer of material may be used to cause a reduction in potential induced stress. Whether used alone or in combination with a thickness gradient distribution, the pattern / matrix can include any suitable pattern. For example, the pattern may include any suitable geometry, dithering design, lattice design, or any random design. Figure 22 and Figure 22A The design shown is a basic design in which the density of features decreases from the first annular portion 2202 toward the optical region opening 2204.

[0179] Figure 23 The basic structure of a cosmetic contact lens formed by the method described above according to the present invention is shown. One or more effect layers and / or colored printing layers 2304 are sandwiched or encapsulated between annular light-transmitting substrate 2302 and body lens material 2306. As previously stated, although only a single effect layer is shown, any number of effect layers can be encapsulated between other two layers. As shown, the contact lens includes an annular light-transmitting substrate material layer 2302 to encapsulate one or more colored printing layers within the body lens material; i.e., a reactive monomer mixture. In other words, with this design, the central optical zone or central optical area 2308 of the contact lens is not covered, thereby maintaining a precise optical surface and path while ensuring complete coverage / encapsulation of the colored layer 2304, in addition to maintaining high comfort. The design of the pad printing plate 2200 with transition portions 2206 forms a transition region 2310 in the annular light-transmitting substrate layer 2302, which provides better fusion / bonding between materials, as described in detail above. According to an exemplary embodiment of the invention, the 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.

[0180] In alternative exemplary embodiments of cosmetic or non-cosmetic contact lenses coated on the front, rear, or both surfaces for reasons other than pigment encapsulation (e.g., for a comfortable lubricating coating), it may be necessary to utilize the annular structure with transition portions disclosed herein to better fuse / bond the materials while maintaining high optical quality. More specifically, if the contact lens is formed from a first material and then a second material is added to one or both surfaces to increase the lens's lubricity, the fusion of the two materials may induce stress as described above. The solution would again be an annular coating / structure with transition portions as described above to reduce any potential induced stress.

[0181] According to another exemplary embodiment, pearlescent pigments can be incorporated into one or more areas or portions of a cosmetic contact lens to add a glossy, shiny, and colorful appearance. For example, these pearlescent pigments can be added to at least a portion of the lens corresponding to the wearer's sclera. The pearlescent luster and interference effect are produced by alternating layers of transparent materials with different refractive indices. Pearlescent pigments can 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 can be silver, gold, and various shades of red, blue, and green.

[0182] Typically, titanium dioxide is currently the preferred pigment used to form bright scleral areas on cosmetic contact lenses. Cosmetic contact lenses according to an exemplary embodiment of the invention incorporate pearlescent pigments into areas corresponding to the wearer's sclera, thereby creating a glossy, shiny, and colorful appearance. In other words, the combination or incorporation of pearlescent pigments (e.g., mica-based pearlescent pigments coated with titanium dioxide) will produce brighter white scleral areas with a wet-reflective appearance and a more natural look. Preferred pearlescent pigments are silver-type, which are mica-based pigments coated with titanium dioxide. Exemplary mica-based pigments are potassium aluminum silicate, which may be coated with titanium dioxide (TiO2) or iron oxide (Fe2O3). EMD Chemicals Inc. provides food and drug approved natural silicates in combination with titanium dioxide, under the trademark [trademark name missing]. However, it is important to note that any pearlescent pigment can be combined with other pearlescent pigments and / or with different types of pigments or dyes and used in the scleral area.

[0183] 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 pupillary area, a translucent pupillary area, a light-colored scleral area, a light-colored scleral area with a geometric pattern, and / or any combination thereof. The limbal ring is preferably opaque or translucent. The iris area may be translucent, opaque, or transparent. The pupillary area may be transparent or not include a pattern. Pigments and dyes can be used to color the pattern elements of the limbal, iris, and pupillary areas of the contact lens. Any organic pigment, inorganic pigment, effect pigment, dye, or any combination thereof can be used to color the pattern elements.

[0184] Now refer to Figure 24 This is a schematic illustration of a cosmetic contact lens 2400 having a bright scleral region 2402 formed from a mixture containing pearlescent pigments according to the invention. The bright scleral region 2402 having pearlescent pigments can be manufactured as follows. A translucent base ink is prepared by adding 35.35 g of 1-propanol to 588.11 g of 1D translucent base material. A more detailed description of the translucent base ink composition and its preparation is given below. The ink sample was then mixed on a Servodyne mixer at 1800 rpm for three (3) minutes. 5.98 g of 1-propanol was added to 20.05 g of Silver Fine pigment (EMDChemicals, Twenty (20)% Silver Fine inks were prepared in a mixture of Pearl Effect Colors and 80.01 g of 1D translucent base material. The mixture was then manually mixed. A steel pad with an etched pattern was filled with the ink mixture and printed onto the surface of the mold as described above. The ink was transferred from the pad to the surface of the mold using a silicone pad. The translucent base ink was printed first, followed by the Silver Fine ink. The lens forming material, i.e., the etafilcon A reactive monomer mixture, was deposited onto the printing mold, and the mold assembly was then completed using complementary half-molds. The lens material was then cured, demolded from the mold, and equilibrated in a buffered saline solution, all as described in more detail above. The pearlescent pigments were encapsulated within the lens material.

[0185] A binder polymer for a translucent base ink was prepared using 96 g of 1-dodecyl mercaptan (DODT), 56.54 g of lauryl methacrylate (LMA), 7.40 g of methacrylic acid (MAA), 1367 g of hydroxyethyl methacrylate (HEMA), 68.5 g of glycerol, 378 g of 1-ethoxy-2-propanol (EP), 1511 g of isopropyl lactate (IPL), and 8.89 g of 2,2'-azobis(2-methylbutyronitrile) (AMBN). First, DODT was added, and the monomers and solvents, except for approximately 50 cc–100 cc of IPL, were mixed and stirred for 10 minutes in a five (5) liter blue-capped flask. The mixture was then poured into a five (5) liter stainless steel reactor equipped with a stirrer and nitrogen. The mixture was stirred and heated for approximately 25 minutes until the temperature reached 68 degrees Celsius. After the temperature stabilized at 68°C, AMBN was dissolved in the remaining IPL and added while the nitrogen vent was open. Polymerization was allowed to proceed for 16-24 hours, after which the temperature was raised to 80°C and the reaction was completed. The mixture was then allowed to equilibrate to room temperature. The viscosity of the mixture was adjusted as needed by mixing four (4) parts of IPL with one (1) part of EP.

[0186] As described above, the lens forming material comprises etafilcon A. Etafilcon A is a well-known and patented material used in the manufacture of contact lenses. Etafilcon A is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with 1,1,1-trimethylolpropane trimethacrylate and ethylene glycol dimethacrylate. Etafilcon A is used in many contact lenses available from Johnson & Johnson Vision Care, Inc. It is important to note that while Etafilcon A is used in the exemplary embodiments described herein, any suitable lens forming material can be used.

[0187] According to another exemplary embodiment, the present invention relates to a cosmetic contact lens comprising one or more effect layers overlying one or more regions of the eye in which it is located, pearlescent pigments incorporated into portions of the contact lens overlying different regions of the eye (e.g., the sclera, iris, or both, as detailed above), and a light-transmitting coating encapsulating the one or more effect layers and the pearlescent pigments. Preferably, the light-transmitting coating has an annular shape as described above, such that the central visual portion of the lens has the highest optical quality. According to another exemplary embodiment, the pearlescent pigments may be incorporated into portions overlying the sclera, iris, and limbal ring, into the sclera and limbal ring, into the limbal ring and iris, into the sclera alone, into the iris alone, or into the limbal ring alone. Furthermore, there may be exemplary embodiments where the limbal ring has the following characteristics and may also contain pearlescent pigments, while in other exemplary embodiments the limbal ring may not be used.

[0188] It is important to note that any part of the contact lens can contain, alone or in combination with each other, an ink composition / dye / pigment to form an effect layer as described herein, and a coated mica-based pearlescent pigment as described herein. For example, a pigment-formed effect layer can be combined with a mica-based pearlescent pigment, a pigment plus mica-based pearlescent pigment effect layer can be combined with a mica-based pearlescent pigment, a pigment plus mica-based pearlescent pigment effect layer can be combined with a pigment plus mica-based pearlescent pigment effect layer, and a mica-based pearlescent pigment-based effect layer can be combined with a mica-based pearlescent pigment-based effect layer and used in any part constituting the contact lens. Furthermore, mica can be used alone to form the effect layer, mica can be used as a light-blocking agent or as a major additive in forming the color composition; for example, mica can be used to produce a more vibrant yellow.

[0189] More specifically, mica-based pearlescent pigments can be used as light-blocking agents to form the limbal ring, or they can be used as a primary element in forming the limbal ring itself. In cases such as Figure 25 In one exemplary embodiment shown, mica-based pearlescent pigments can be added to the limbal ring effect to add brightness and shimmer to the limbal ring. Figure 25The image shows a first exemplary embodiment of a limbal ring-conical spoke pattern on a contact lens 2500. In this exemplary embodiment, the limbal ring 2502 is a black, opaque band approximately 1 mm wide. Starting from 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 conical spokes 2506, the innermost boundaries 2512 of which form circles with a diameter of 7 mm, as measured from the geometric center of the contact lens 2500. Although all spokes 2506 are generally constructed similarly, preferably, no single spoke 2506 is identical to any other spoke 2506. The spokes 2506 are scattered or demarcated by spaces 2508, in which no element exists. The spaces 2508 are also generally constructed similarly, but preferably, no single space 2508 has a construction identical to any other space 2508 or spoke 2506. Region 2510 is the area without patterned elements, as shown in the figure. This region will partially constitute the iris portion of the wearer's eye and the entire pupil portion of the wearer's eye, or the portion of the lens covering the wearer's pupil when the lens is on and centered on the eye. As shown in the figure, region 2510 is translucent, but it can also be colored translucently or opaquely. The innermost boundary 2504 shown has a uniform, regular shape, but it can also be an uneven, irregular boundary. Similarly, while the conical spoke boundary 2512 forms a substantially uniform boundary, it can form an uneven boundary. Mica-based pearlescent pigment 2514 is encapsulated within the limbal ring region 2502 and can be a random or non-random pattern. It is important to note that mica-based pearlescent pigment can be incorporated into any design shown herein.

[0190] Mica-based pearlescent pigments can be used to form portions covering the iris area. For example, they can be used to create effect layers. Different coatings on mica can be utilized. Mica-based pearlescent pigments can be added to existing effect layers. They can also be added to existing effect layers as opacifiers. Furthermore, mica-based pigments can be used to develop new colors.

[0191] Now refer to Figure 26 This illustrates an exemplary effect design graphic 2600 of a cosmetic contact lens that covers the iris area of ​​the wearer's eye. From Figure 26As can be seen, this design graphic does not include a limbal ring like most other designs, thus creating a completely different effect. Furthermore, unlike other designs, this exemplary embodiment only includes mica-based pearlescent pigment 2602 constituting the design. The mica-based pearlescent pigment 2602 is located within the iris region and can be a random or non-random pattern. Additionally, as described herein, the mica-based pearlescent pigment can be coated with various other materials to change their color or add additional effects. In other exemplary embodiments, effect layers (such as the effect layer shown) can contain a combination of standard pigments and pearlescent pigments as described above. It is important to note that although… Figure 26 It is shown as a regular shape for the pigment, but it can take any shape other than a ring.

[0192] Mica-based pearlescent pigments can be used to form portions overlaid on the scleral region. For example, they can be used to form an effect layer in the sclera. Different coatings can be applied to mica. Mica-based pearlescent pigments can be added to existing effect layers in the scleral region, for example, to brighten the color. They can also be added to the scleral region as a light-blocking agent. Furthermore, mica-based pigments can be used to develop new colors for the scleral region. The degree and amount of mica-based pearlescent pigment added to one or more portions or areas of a contact lens can be adjusted according to the desired effect, from subtle to noticeable.

[0193] Rotatable contact lens design

[0194] According to yet another exemplary embodiment, cosmetic contact lenses can be made reversible, thereby providing a variety of effects. In other words, a single contact lens can provide two different eye enhancement effects simply by removing it from the eye, flipping it over, and then putting it back on. In this way, cosmetic effect options can be provided to contact lens wearers with a single lens, rather than requiring the purchase of two lenses to achieve different effects. It is conceivable that individuals may want to alter their appearance throughout the day. For example, people might prefer a more subtle effect while at work and a more dynamic effect during post-work activities or non-work activities. Using this type of reversible lens, any type of effect can be utilized, from color changes through reversal to changes in the presence or absence of pearlescent pigments.

[0195] The reversible cosmetic contact lens of the present invention is designed to provide interchangeable cosmetic appearances on the eyes. This effect may include variations in one or more of color, pattern, and / or effect. The resulting interchangeable cosmetic appearances can be customized based on printing order, design / pattern, color, pattern alignment, and opacity level, etc., as described herein. Therefore, a description of the reversible soft contact lens is given below. Regardless of how it is worn, this lens provides the same corrective power and comfort.

[0196] Soft contact lenses can be designed to have one or more base curves, a diameter, and one or more anterior curvatures. The base curves are configured to conform the lens to the corneal / scleral contour of the wearer's eye. The diameter is typically larger than the corneal diameter, and the anterior curvatures provide the lens's refractive function. Because soft contact lenses can be made of flexible materials, they can conform to the corneal / scleral contour and "wrap" around the eye. See [link to relevant documentation]. Figure 27A When the contact lens curve changes, this wrapping or deformation from the lens's flipped state can have a significant refractive effect on the eye in order to adapt to the contours of the cornea and sclera. As the lens flips, the front surface becomes the back surface, and when the flipped lens wraps around the eye, the back surface will contact the surface of the eye. See [link to relevant documentation]. Figure 27B Furthermore, the effect of the lens coating on the refractive power of the lens can also depend on whether the lens is applied to the eye in a primary orientation or a flipped / inner-out orientation.

[0197] According to the present invention, the behavior of the lens in various orientations can be modeled (e.g., using finite element analysis (FEA), using MSC Marc software, etc.) to simulate lens reversal, lens wrapping on the eye, and lens handling, such as placing the lens on the eye using a finger or tool. Figures 28A to 28B This illustrates a conventional soft contact lens in a primary orientation assumed to be strain-free. Figure 28A ) and the reversal or inner surface orientation with residual strain after forcing the lens to buckle ( Figure 28B Strain modeling on the lens. When a lens with a standard design is reversed, the peripheral thickness resists deformation and residual strain will exist in the lens in the reversed configuration. This corresponds to the lens edges opening up, thus increasing the diameter (reducing sag), and ultimately, the fit to the eye is different when worn. In fact, based on the current operation of soft contact lens users, the greater the parallax between the primary and reversed configurations, the easier it is to visually identify whether the lens is inside out. Figures 29A to 29B Strain modeling of a soft contact lens (e.g., with reduced peripheral thickness) according to this disclosure is shown, wherein the lens is in a primary orientation ( Figure 29A ) and reverse or inner face in outer orientation ( Figure 29B By managing (e.g., eliminating, minimizing, etc.) the peripheral thickness, the main resistance to lens flipping is reduced, so the lens diameter and sag will be closer to the initial expected values ​​in the primary configuration (before flipping), that is, minimizing the deviation of the diameter or sag (dDiam or dSag) between the primary orientation and the inner-outer orientation.

[0198] A potential drawback of reducing peripheral thickness is increased difficulty in lens handling (e.g., fragility and folding). Several design alternatives according to the invention were generated and manufactured for evaluation. In one aspect, fourteen (14) subjects were surveyed based on two indicators / questions: 1) the ease of identifying whether a lens was inner-side-out, and 2) the ease of handling each of five (5) sample lenses. These five lenses included a control lens and four (4) test lenses of different variations of the proposed design, each lens having a specified diameter (D), base curve (BC), and center thickness (CT) in millimeters (mm):

[0199] Controls: D14.2, BC8.5, CT0.085

[0200] Design 403: D14.3, BC8.1, CT0.1

[0201] Design 404: D14.3, BC8.1, CT0.2

[0202] Design 405: D14.3, BC8.3, CT0.1

[0203] Design 406: D14.3, BC8.5, CT0.1

[0204] Figure 30 shows a list of survey ratings for fourteen (14) participants, with the ratings as follows:

[0205] 1 = Very difficult

[0206] 2 = Some difficulty

[0207] 3 = Relatively easy

[0208] 4 = Very easy

[0209] Table 1 shows the average scores from surveys used to distinguish between I / O (inside-out) and processing.

[0210]

[0211]

[0212] Table 1

[0213] Based on Table 1 and subjective feedback, Design 405 appears to perform best in two aspects: it is easy to handle, but more difficult to discern whether the inside is facing out. Figure 31 A graph is shown illustrating the relationship between simulated dSag (deviation of sag after reversal) and survey scores on the ease of discerning whether a lens is inner-side-out. This graph demonstrates that simulated dSag can be used as a predictor of I / O scores.

[0214] To further investigate the range of applicable design parameters, design 405 was selected as the optimal design, and the range of variation for diameter, base arc, and center thickness was proposed for further evaluation, as shown in Table 2.

[0215] diameter 13.8 14 14.3 14.5 14.8 BC 8 8.1 8.3 8.5 8.6 CT 60 80 100 150 200

[0216] Table 2

[0217] Within the parameter range mentioned above (as shown in Table 2), in addition to the original eighteen (18) designs (45 design variants in total), twenty-seven (27) design combinations were generated and evaluated for flip simulation. Figure 32 A graph is shown illustrating the resulting design space for diameter, base arc, and CT, and the impact of diameter, base arc, and CT on the simulated index dSag, indicated by the size of a marker (e.g., the diameter of a circular marker). A smaller dSag indicates less distinguishable I / O and better performance.

[0218] Based on the data in Table 1 and the relationship between the simulated index dSag and the ease of identifying I / O ( Figure 31 The limits of the preferred dSag and the acceptable dSag can be estimated as follows:

[0219] The ease of identifying I / O is preferred if it is <1.2% and <==> dSag <1%.

[0220] The difficulty level of identifying I / O is acceptable if <2% is acceptable and <==> dSag <1.3%.

[0221] Terms such as preferred and acceptable are used herein to distinguish exemplary levels of performance and are not intended to indicate preferred or best implementations. Other performance ranges may be used. Using these constraints on the simulation index dSag, we can identify preferred (Table 3) and acceptable (Table 4) designs from the forty-five (45) designs given in Table 2:

[0222]

[0223] Table 3

[0224]

[0225] Table 4

[0226] Material properties (e.g., elastic modulus measured using ANSI Z80.20) can affect the mechanical behavior of the lens. To investigate the effect of material properties, the modulus was varied between 150 kPa and 660 kPa. Repeated flipping and treatment simulations were performed to evaluate the treatment and indices for distinguishing the inner surface from the outer surface (I / O), and the results are shown in Table 5.

[0227] Modulus (kPa) I / O index = dSag Treatment index = drooping on the finger 150 0.043 1.4 270 0.043 2.62 420 0.043 3.306 660 0.043 3.788

[0228] Table 5

[0229] The data in Table 5 show that increasing the modulus can improve the handling of reversible lenses without affecting the lens's flip shape, which is the desired result.

[0230] In contact lenses, the peripheral edges can affect overall comfort. For example, Figure 33 A model is shown where the peripheral edge of a conventional contact lens wraps around the primary orientation. As shown, when the lens edge is in full contact with the eye, the edge wraps around in a manner that is generally comfortable for the wearer. For comparison, Figure 34 This illustrates a model where the peripheral edge of a conventional contact lens is either reversed or oriented outwards. As shown, the peripheral edge wraps differently relative to the wearer's eye, and there is a gap between the edge apex and the eye surface. This can cause discomfort to the wearer as the eyelid repeatedly travels from the eye surface to the contact lens during blinking.

[0231] However, according to the present invention, by utilizing edge profiles that are symmetrical or substantially similar about both sides of the lens, the difference in eye comfort between the two orientations can be minimized. In addition, or alternatively, the existing gap between the edge apex and the eye surface (i.e., the apex height) can be reduced in either orientation. For example, Figure 35 A model is shown in which the peripheral edge of a contact lens according to this disclosure is wrapped along the primary orientation. For comparison, Figure 36 A model is shown in which the peripheral edge of a contact lens according to this disclosure is reversed or the inner surface is oriented outwards.

[0232] As an ophthalmic medical device providing vision correction, a reversible soft contact lens requires either orientation to provide equivalent optical power correction. Considering the incompressible nature of the soft contact lens material and the fact that the lens wraps around the eye when placed on either side, it can be inferred that the optical area of ​​the contact lens will deform into a similar curvature or shape on the eye when placed in either orientation. Preliminary optomechanical simulations were performed using lens designs with primary and reversible orientations according to this disclosure. The analysis was repeated for designs with different optical powers (-4.00D, 0.00D, +4.00D). Optical analyses were performed assuming both the unwrap lens geometry and the wrap lens geometry (estimated via FEA). Figures 37A to 37D The graphs show the optical analysis based on a 0.00D lens in both primary orientation and reverse or inner surface outward orientation. Figures 37A to 37D The graphs shown compare the lens profile and its calculated power distribution. They illustrate the differences between primary orientation and inner-outer orientation. Figures 37A to 37B The lens power exhibits minimal variation (within the optical region where r < 4 mm). Especially when the lens is wrapped around the eye, the differences in optical power distribution disappear. Figures 37C to 37D ( ), because the geometry becomes identical.

[0233] Figures 38A to 38D Plots are shown based on optical analysis of a -4.00D lens in both primary orientation and reverse or inner-to-outer orientation. These plots compare the lens profile and its calculated power distribution. They show minimal difference between the two sides ( Figures 38A to 38B Especially when the lens is wrapped around the eye, the differences in optical power distribution disappear. Figures 38C to 38D ( ), because the geometry becomes identical.

[0234] Figures 39A to 39D Plots are shown based on optical analysis of a +4.00D lens in both primary orientation and reverse or inner-to-outer orientation. These plots compare the lens profile and its calculated power distribution. They show minimal difference between the two sides ( Figures 39A to 39B Especially when the lens is wrapped around the eye, the differences in optical power distribution disappear. Figures 39C to 39D ( ), because the geometry becomes identical.

[0235] These optomechanical simulations support the concept that vision achieved through the design of flip-up lenses according to the invention may be independent of lens orientation.

[0236] As described in this article, the peripheral region of the lens can be designed to minimize the parallax of the base curve and diameter between the primary orientation and the inner-outward orientation. The effect of peripheral thickness on this parallax depends on the lens diameter, base curve, and center thickness, which must be optimized together with the peripheral thickness to achieve optimal performance. When the lens base curve and diameter are comparable between the primary orientation and the inner-outward orientation, the expected ocular fit and visual performance are comparable.

[0237] Examples of flip-up cosmetic contact lenses

[0238] like Figure 19 and Figure 20As shown, the reversible cosmetic contact lens of the present invention is manufactured by pad printing using a translucent annular base material, followed by several effect layers for color and graphic patterns, including optional blocking layers, which can be continuous, discontinuous, or any combination thereof, that restrict the effect only to a non-reversed or reversed orientation. The efficiency of the blocking layer depends on its position and opacity and can completely or partially exclude the effect on one orientation or the other. The pad printing process may also include additional annular translucent base material layers between the effect layers to provide spacing or depth to the overall graphic design. The front-curved mold and base-curved mold used in the above pad printing process are designed such that one or more of the diameter, base arc, peripheral thickness, or center thickness are configured such that when a first orientation of at least a portion of the first surface adjacent to the body of the wearer's eye is compared with a second orientation of at least a portion of the second surface adjacent to the body of the wearer's eye, dSag is less than 1.3%. Alternatively, the front surface mold and the base surface mold used in the above pad printing process are designed such that one or more of the diameter, base arc, or thickness profile are configured such that when the lens is in the reverse orientation of at least a portion of its second surface adjacent to the wearer's eye, the vertex height measured from the edge vertex to the nearest surface of the eye is less than or equal to 0.020 mm.

[0239] like Figure 40 As shown, the reversible cosmetic contact lens of the present invention presents one graphic design on the non-reversible orientation (A side) and another cosmetic design on the reverse orientation (B side). Side A represents a dark pattern with a lighter internal highlight, while side B represents a lighter pattern with a more pronounced limbal ring. The exact color, as well as the level of opacity and pearlescent sheen, may vary between these cosmetic designs.

[0240] The colorants used in inks for pad printing can be uncoated or coated pigments, and can 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 fluorophlogopite, and borosilicates. The opacity or translucency of the effect layer can vary depending on the ink concentration and coverage level. A blocking layer is optional but typically opaque to prevent the color of the underlying layer from appearing on the opposite side. Typically, the blocking layer is lightly colored to provide a clean background for another graphic design, for example, by pad printing a titanium dioxide layer.

[0241] Although the reversible cosmetic contact lens of the present invention is not limited by the number or order of effect layers in the pad printing process, there are several preferred layer combinations as described below. The non-reversible and reversible cosmetic designs are the sum of all effect layers, blocking layers, and light-transmitting base layers within the reversible cosmetic contact lens.

[0242] First, a reversible cosmetic contact lens is manufactured using a mold assembly in the following pad printing sequence, the mold assembly being configured such that the dSag between non-reversible and reversible lens orientations is less than 1.3%, or alternatively such that the vertex height measured from the edge vertex to the nearest surface of the eye in the reversible orientation is less than or equal to 0.020 mm: (1) a translucent base layer is printed on the inner surface of the anterior curved mold, and then (2) a cosmetic design is printed, highlighting the iris with an inner effect design graphic and an outer effect design graphic, one on top of the other, such that at least one cosmetic design is opaque. In this way, the other cosmetic design can be translucent. The cosmetic design may also include the same or different limbal design graphics. The selected designs are printed such that they at least partially overlap each other when viewed in wear. These designs may be cosmetically identical, nearly identical, or substantially different in shape, color, and their combination. Examples of inner effect design graphics and outer effect design graphics are shown in Figure 14B , Figure 14C , Figure 15B , Figure 15C , Figure 16B , Figure 16C , Figure 17B , Figure 17C , Figure 18B and Figure 18C The example of a limbal design graphic is shown in [the image]. Figure 14A , Figure 15A , Figure 16A , Figure 17A and Figure 18A Examples of beauty designs are shown in [the image / image]. Figure 14D , Figure 15D , Figure 16D , Figure 17D and Figure 18D As shown in the image.

[0243] Next, a reversible cosmetic contact lens is manufactured using a mold assembly in the following pad printing sequence, the mold assembly being configured such that dSag is less than 1.3% between non-reversible and reversible lens orientations, or alternatively such that the vertex height measured from the edge vertex to the nearest surface of the eye in the reversible orientation is less than or equal to 0.020 mm: (1) a translucent base layer is printed on the inner surface of the anterior curved mold, and then (2) two cosmetic designs are printed, which use an inner effect design graphic and an outer effect design graphic to highlight the iris, one on top of the other, with a certain degree of overlap and a blocking layer in between. In this way, the two cosmetic designs can be translucent. The translucency can vary between the cosmetic designs. Alternatively, the blocking layer can be partially opaque and can form a common limbal design graphic. The two cosmetic designs can also include the same or different limbal design graphics. The selected cosmetic design or blocking layer design is printed to at least partially overlap each other when viewed in wear. In general, the cosmetic or blocking layer designs can be cosmetically identical, nearly identical, or substantially different in shape, color, and their combination. Examples of interior and exterior effect design graphics are shown in Figure 14B , Figure 14C , Figure 15B , Figure 15C , Figure 16B , Figure 16C , Figure 17B , Figure 17C , Figure 18B and Figure 18C The example of a limbal design graphic is shown in [the image]. Figure 14A , Figure 15A , Figure 16A , Figure 17A and Figure 18A Examples of beauty designs are shown in [the image / image]. Figure 14D , Figure 15D , Figure 16D , Figure 17D and Figure 18D As shown in the image.

[0244] Third, reversible cosmetic contact lenses are manufactured using a mold assembly in the following pad printing sequence, the mold assembly being configured such that dSag is less than 1.3% between non-reversible and reversible lens orientations, or alternatively such that the vertex height measured from the edge vertex to the nearest surface of the eye is less than or equal to 0.020 mm in the reversible orientation: (1) a translucent base layer is printed on the inner surface of the anterior curved mold, and then (2) two cosmetic designs are printed, which use an inner effect design graphic and an outer effect design graphic to highlight the iris, such that the inner effect design graphic and the outer effect design graphic form a fusion layer between the two cosmetic designs highlighting the iris. The fusion layer can be translucent or opaque. In this way, the fusion layer is visible in both non-reversible and reversible orientations. Alternatively, only one cosmetic design highlighting the iris includes the fusion layer, and the two cosmetic designs are separated by a blocking layer. In addition, one or both cosmetic designs may include a limbal design graphic. Examples of inner effect design graphics and outer effect design graphics are shown in Figure 14B , Figure 14C , Figure 15B , Figure 15C , Figure 16B , Figure 16C , Figure 17B , Figure 17C , Figure 18B and Figure 18C The example of a limbal design graphic is shown in [the image]. Figure 14A , Figure 15A , Figure 16A , Figure 17A and Figure 18A Examples of beauty designs are shown in [the image / image]. Figure 14D , Figure 15D , Figure 16D , Figure 17D and Figure 18D As shown in the image.

[0245] Fourth, reversible cosmetic contact lenses are manufactured using a mold assembly in the following pad printing sequence, the mold assembly being configured such that dSag is less than 1.3% between non-reversed and reversed lens orientations, or alternatively such that the vertex height measured from the edge vertex to the nearest surface of the eye is less than or equal to 0.020 mm in the reversed orientation: any of the above-described preferred layer combinations with an additional translucent base layer printed between any or all effect layers, thereby adding three-dimensional or depth features to the cosmetic design.

[0246] While the embodiments shown and described are believed to be the most practical and preferred embodiments, it will be apparent to those skilled in the art that changes can be made to the specific designs and methods described and shown, and these changes can be used without departing from the spirit and scope of the invention. The invention is not limited to the specific constructions described and shown, but should be constructed to conform to all modifications that fall within the scope of the appended claims.

[0247] The following abbreviations will be used throughout the embodiments and have the following meanings:

[0248] TL03 bulb: Phillips TLK 40W / 03 bulb or TLK 20W / 03 bulb

[0249] LED: Light Emitting Diode

[0250] BC: Base Curved Surface Plastic Mold

[0251] FC: Front Curved Surface Plastic Mold

[0252] PS: Polystyrene is a homopolymer of styrene and is used as a resin or component in plastic molding processes. It may contain additives.

[0253] PP: Polypropylene, a homopolymer of propylene used as a resin or component in plastic molding, and may contain additives.

[0254] TT: Tuftec, a hydrogenated styrene-butadiene block copolymer (Asahi Kasei Chemicals) used as a plastic molding resin or component, and may contain additives.

[0255] Z: Zeonor, a polycyclic olefin thermoplastic polymer (Nippon Zeon Co Ltd) used as a plastic molding resin or component, and may contain additives.

[0256] RMM: Reactive Monomer Mixture

[0257] HEMA: 2-Hydroxyethyl Methacrylate (Bimax)

[0258] MAA: Acros

[0259] EGDMA: Ethylene dimethacrylate (Esstech)

[0260] TMPTMA: Trimethylolpropane trimethacrylate (Esstech)

[0261] Omnirad 1700: A mixture of bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphine oxide and 2-hydroxy-2-methyl-1-phenyl-prop-1-one.

[0262] AIBN: Azobisisobutyronitrile (initiator)

[0263] DODT: 1-Dodecathiol (chain transfer agent)

[0264] mPDMS: Mono-n-butyl-terminated monomethacryloyloxypropyl-terminated polydimethylsiloxane (M n =800 Daltons - 1500 Daltons (Gelest)

[0265] Norbloc: 2-(2'-hydroxy-5-methacryloyloxyethylphenyl)-2H-benzotriazole (Janssen)

[0266] Blue HEMA: 1-Amino-4-[3-(4-(2-methacryloyloxy-ethoxy)-6-chlorotriazine-2-ylamino)-4-sulfophenylamino]anthraquinone-2-sulfonic acid, as described in U.S. Patent No. 5,944,853

[0267] DIW: Deionized Water

[0268] Tween 80: Polysorbate 80 or Polyoxyethylene 20 sorbitol monooleate (Croda)

[0269] PPM: Parts per million by weight

[0270] IPA: Isopropyl alcohol

[0271] 1E2P: 1-Ethoxy-2-propanol

[0272] IPL: Isopropyl lactate

[0273] Filling solution: 0.84 wt% sodium chloride, 0.91 wt% boric acid, 0.24 wt% sodium borate decahydrate, 0.01 wt% disodium ethylenediaminetetraacetate and 98 wt% deionized water.

[0274] BAGE: Glyceryl borate (molar ratio of boric acid to glycerol is 1:2) In a suitable reactor, 299.3 g (mol) of glycerol and 99.8 g (mol) of boric acid were dissolved in 1247.4 g of 5% (w / w) EDTA aqueous solution, and then heated to 90-94 °C with stirring under mild vacuum (2-6 Torr) for 4-5 hours, and then cooled to room temperature.

[0275] pigment:

[0276] Titanium dioxide: Cosmetic White C47-060 (Chempilots)

[0277] Iron oxide black: Sicotit Black 85E172 (Chempilots)

[0278] Iron oxide brown: Sicotit Brown 75E172 (Chempilots)

[0279] Iron oxide red: Sicotit Red 30E172 (Chempilots)

[0280] Trans Oxide Red (AC1000, Chempilots)

[0281] Iron oxide yellow: Sicotit Yellow 10E172 (Chempilots)

[0282] Trans Oxide Yellow AC0500 (Chempilots)

[0283] Phthalocyanine Blue 15 (Chempilots)

[0284] Phthalocyanine Green (Chempilots)

[0285] Carbazole Violet 23 (Chempilots)

[0286] Spectraval Blue (Merck KGaA, EMD Performance Materials)

[0287] Spectraval Green (Merck KGaA, EMD Performance Materials)

[0288] Spectraval Red (Merck KGaA, EMD Performance Materials)

[0289] Spectraval White (Merck KGaA, EMD Performance Materials)

[0290] Golden luster (Merck KGaA, EMD Performance Materials)

[0291] Operational Examples

[0292] Preparation of translucent base ink #1

[0293] A binder copolymer having approximately 1.4 wt% MAA repeating units was prepared from HEMA and MAA via free radical polymerization using AIBN as an initiator and DODT as a chain transfer agent. The copolymerization conditions can be varied to control the composition, molecular weight, and molecular weight distribution of the binder copolymer. The composition is approximately 1.4 wt% MAA repeating units, approximately 96.6 wt% HEMA repeating units, and approximately 2 wt% DODT. The binder copolymer interacts with and stabilizes the pigment / dye dispersion. The binder copolymer is dissolved in a 4:1 (w / w) solution of IPL:1E2P with a concentration ranging from approximately 20 wt% to approximately 40 wt%. A typical binder copolymer concentration is 30 wt%. The solution viscosity can be adjusted as needed by diluting with a 4:1 (w / w) solution of IPL:1E2P or with 1-propanol. 1-Propanol is preferred.

[0294] Color ink preparation

[0295] Colored inks are prepared by mixing pigments and / or dyes at specific concentrations into translucent base inks to impart desired color, pattern, and / or effect in cosmetic contact lenses. The concentrations of pigments and dyes can vary from about 1% by weight to about 25% by weight, 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 adjacent viscosities or after a change in evaporation rate. Table A lists nine exemplary colored ink compositions. The concentrations of specific pigments or dyes are listed as weight percentages. The translucent base ink contains about 30% by weight of a binder copolymer in a 4:1 (w / w) solution of IPL:1E2P, which consists of about 1.4% by weight MAA repeating units, about 96.6% by weight HEMA repeating units, and about 2% by weight DODT. The Brinell viscosity of these colored inks is reduced by adding 1-propanol to the initial pigment / dye dispersion, such that the Brinell viscosity is between about 5,000 centipoise and about 8,000 centipoise, preferably between about 5,500 centipoise and 6,500 centipoise.

[0296] Table A. Colored Ink Formulations

[0297] (Pigment / dye concentration, by weight percentage)

[0298]

[0299]

[0300] Example 1

[0301] Printed contact lenses are manufactured on an automated pilot production line capable of pad printing and contact lens manufacturing, where the oxygen level is maintained between 0.5% and 5%. An annular translucent coating is pad-printed onto a front-curved die and a base-curved die, both designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front-curved die is made of polystyrene, and the base-curved die is made of Zeonor. Before use, the front-curved die and base-curved die are degassed for approximately twelve hours. After the translucent coating has dried sufficiently (dried enough to deposit the next layer without lifting or altering the translucent coating), a green ink #1 is used to coat the lens. Figure 41A The effect layer pattern shown is printed onto the translucent coating using a pad printing plate. After the effect layer pattern has fully dried (dry enough to deposit the next layer without lifting or altering the first printed layer), a gray ink #2 is used to print the effect layer pattern. Figure 41B The barrier layer pad printing plate shows the pattern. After the barrier layer is fully dried (dry enough to deposit the next layer without lifting or altering the barrier printing layer), print with blue ink #3. Figure 41C The effect of the pattern shown is achieved by printing a pad, thereby producing... Figure 41D The pattern shown.

[0302] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0303] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC, and hydrated by immersing them in a diluent containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in a filler solution at 70°C for another hour. It is recognized by those skilled in the art that the exact lens demolding process can vary depending on the lens formulation and mold material. The aim of the lens demolding process is to ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to foil-heat-sealed blister packs and subsequently sterilized by autoclaving at 124°C for approximately 18 minutes.

[0304] Table B. Reactive Monomer Mixtures

[0305] Components weight% HEMA 95 MAA 2 EGDMA 0.8 TMPTMA 0.08 Norbloc 1 Blue-HEMA 0.02 Omnirad 1700 1.1 ΣRMM components 100 diluent BAGE diluent concentration 48

[0306] Example 2

[0307] Printed contact lenses are manufactured on an automated pilot production line capable of pad printing and contact lens manufacturing, where the oxygen level is maintained between 0.5% and 5%. An annular translucent coating is pad-printed onto a front-curved die and a base-curved die, both designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front-curved die is made of polystyrene, and the base-curved die is made of Zeonor. Before use, the front-curved die and base-curved die are degassed for approximately twelve hours. After the translucent coating has dried sufficiently (dry enough to deposit the next layer without lifting or altering the translucent coating), a gold ink #8 is applied to the lens. Figure 42A The effect layer pattern shown is printed onto the translucent coating using a pad printing plate, creating a shimmering effect. After the effect layer pattern has fully dried (dry enough to deposit the next layer without lifting or altering the first printed layer), a pattern with white ink #9 is printed. Figure 42B The barrier layer pad printing plate shows the pattern. After the barrier layer is fully dried (dry enough to deposit the next layer without lifting or altering the barrier printing layer), print with pink ink #4. Figure 42C The effect layer of the pattern shown is printed on a pad, thereby producing... Figure 42D The pattern shown.

[0308] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0309] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC, and hydrated by immersing them in a diluent containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in a filler solution at 70°C for another hour. It is recognized by those skilled in the art that the exact lens demolding process can vary depending on the lens formulation and mold material. The aim of the lens demolding process is to ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to foil-heat-sealed blister packs and subsequently sterilized by autoclaving at 124°C for approximately 18 minutes.

[0310] Example 3

[0311] Printed contact lenses are manufactured on an automated pilot production line capable of pad printing and contact lens manufacturing, where the oxygen level is maintained between 0.5% and 5%. An annular translucent coating is pad-printed onto a front-curved die and a base-curved die, both designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front-curved die is made of polystyrene, and the base-curved die is made of Zeonor. Before use, the front-curved die and base-curved die are degassed for approximately twelve hours. After the translucent coating has dried sufficiently (dried enough to deposit the next layer without lifting or altering the translucent coating), a yellow ink #5 is used to coat the lens. Figure 15B The effect layer pattern shown is printed onto the translucent coating using a pad printing plate. After the effect layer pattern has dried sufficiently (dry enough to deposit the next layer without lifting or altering the first printed layer), brown ink #6 is used to apply the effect layer pattern. Figure 16AThe limbal pattern shown is printed onto a translucent coating using a limbal pattern transfer plate. After the limbal pattern has dried sufficiently (dry enough to deposit the next layer without lifting or altering the limbal layer), it is printed using green ink #7. Figure 15B The effect layer of the pattern shown is applied using a transfer printing plate to create a shiny effect.

[0312] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0313] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC, and hydrated by immersing them in a diluent containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in a filler solution at 70°C for another hour. It is recognized by those skilled in the art that the exact lens demolding process can vary depending on the lens formulation and mold material. The aim of the lens demolding process is to ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to foil-heat-sealed blister packs and subsequently sterilized by autoclaving at 124°C for approximately 18 minutes.

[0314] Example 4

[0315] Printed contact lenses are manufactured on an automated pilot production line capable of pad printing and contact lens manufacturing, where the oxygen level is maintained between 0.5% and 5%. An annular translucent coating is pad-printed onto a front-curved die and a base-curved die, both designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the front-curved die is made of polystyrene, and the base-curved die is made of Zeonor. Before use, the front-curved die and base-curved die are degassed for approximately twelve hours. After the translucent coating has dried sufficiently (dried enough to deposit the next layer without lifting or altering the translucent coating), a brown ink #6 is used to coat the lens. Figure 16A The limbal pattern shown is printed onto a translucent coating using a stencil. After the limbal pattern has dried sufficiently (dry enough to deposit the next layer without lifting or altering the limbal layer), green ink #3 is used to apply the pattern. Figure 15B The effect layer pattern shown is printed onto the translucent coating using a pad printing plate. After the effect layer pattern has dried sufficiently (dry enough to deposit the next layer without lifting or altering the previous printed layer), a gray ink #2 is used to print the effect layer pattern. Figure 16C The barrier layer pad printing plate shows the pattern. After the barrier layer is fully dried (dry enough to deposit the next layer without lifting or altering the previous printed layer), the pattern is printed using blue ink #3. Figure 15B The effect layer of the pattern shown is a transfer printing plate.

[0316] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0317] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC, and hydrated by immersing them in a diluent containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in a filler solution at 70°C for another hour. It is recognized by those skilled in the art that the exact lens demolding process can vary depending on the lens formulation and mold material. The aim of the lens demolding process is to ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to foil-heat-sealed blister packs and subsequently sterilized by autoclaving at 124°C for approximately 18 minutes.

[0318] Preliminary Implementation

[0319] Preparation of translucent base ink #1

[0320] A binder copolymer having about 1.4 wt% MAA repeating units was prepared from HEMA and MAA via free radical polymerization using AIBN as an initiator and (optionally) DODT as a chain transfer agent. Copolymerization conditions can be varied to control the composition, molecular weight, and molecular weight distribution of the binder copolymer. A typical composition is about 1.4 wt% MAA repeating units, about 96.6 wt% HEMA repeating units, and about 2 wt% DODT. The binder copolymer interacts with and stabilizes the pigment / dye dispersion. The binder copolymer was dissolved in a 4:1 (w / w) solution of IPL:1E2P with a concentration ranging from about 20 wt% to about 40 wt%. A typical binder copolymer concentration is 30 wt%. The solution viscosity can be adjusted as needed by dilution with a 4:1 (w / w) solution of IPL:1E2P or with 1-propanol. 1-Propanol is preferred.

[0321] Color ink preparation

[0322] Colored inks are prepared by mixing pigments and / or dyes at specific concentrations into translucent base inks to impart desired color, pattern, and / or effect in cosmetic contact lenses. The concentrations of pigments and dyes may vary between about 1% by weight and about 25% by weight, depending on the opacity, translucency, or transparency of the printed layer. 1-Propanol may be added after the pigments and dyes have been added to adjacent viscosities or after a change in evaporation rate. Table C lists ten exemplary colored ink compositions. The concentrations of specific pigments or dyes are listed as weight percentages. The translucent base ink contains about 30% by weight of a binder copolymer in a 4:1 (w / w) solution of IPL:1E2P, which consists of about 1.4% by weight MAA repeating units, about 96.6% by weight HEMA repeating units, and about 2% by weight DODT. The Brinell viscosity of these colored inks is reduced by adding 1-propanol to the initial pigment / dye dispersion, such that the Brinell viscosity is between about 5,000 centipoise and about 8,000 centipoise, preferably between about 5,500 centipoise and 6,500 centipoise.

[0323] Table C. Colored Ink Formulations

[0324] (Pigment / dye concentration, by weight percentage)

[0325]

[0326]

[0327] Example 5

[0328] Printed contact lenses are manufactured in a glove box where the oxygen level is maintained between 0.5% and 5%. Using a front-curved die and a base-curved die, a ring-shaped translucent coating is printed onto the front-curved die using a lab-scale pad printing machine. The front-curved die and base-curved die are designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. Typically, the front-curved die and base-curved die are degassed for approximately twelve hours before use. After the translucent coating has dried, a brown ink #16 is used to print the... Figure 14A The limbal stencil pattern shown is printed onto the light-transmitting coating. After the limbal pattern has dried, orange ink #15 is used to apply the... Figure 14B The inner effect pattern shown is printed onto a translucent coating using a pad printing plate. After the inner effect pattern has dried, gray ink #4 is used to apply the inner effect pattern onto the translucent coating. Figure 14CThe pattern shown is printed onto a translucent coating using a pad printing plate, thereby forming... Figure 14D The pattern shown. An optional barrier layer can be printed. For example, black ink #20 can be used to print a pattern with... Figure 14C The pattern shown is applied using a pad printing plate onto a translucent coating. A second translucent coating can also be printed to separate the printing layers used for the non-reverse and reverse patterns. Using brown ink #16 will now create... Figure 15A The limbal stencil pattern shown is printed onto the light-transmitting coating. After the limbal pattern has dried, red ink #19 is used to apply the... Figure 15B The inner effect pattern shown is printed onto a translucent coating using a pad printing technique, with red ink adding different colors and shimmering effects. After the inner effect pattern has dried, gray ink #14 is used to create a final effect. Figure 15C The pattern shown is printed onto a translucent coating using a pad printing plate, thereby forming... Figure 15D The pattern shown. The second set of printed layers can also be rotated and offset from the first set of printed layers, so that some aspects of the first pattern can be seen through the second pattern, and vice versa.

[0329] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0330] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC. Hydration is achieved by immersing the lenses in a diluent solution containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in the filler solution at 70°C for another hour. It is understood by those skilled in the art 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 ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to vials and sterilized by autoclaving at 121°C for approximately 30 minutes.

[0331] Example 6

[0332] Printed contact lenses are manufactured in a glove box where the oxygen level is maintained between 0.5% and 5%. Using a front-curved die and a base-curved die, a ring-shaped translucent coating is printed onto the front-curved die using a laboratory-scale pad printing machine. The front-curved die and base-curved die are designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. Typically, the front-curved die and base-curved die are degassed for approximately twelve hours before use. After the translucent coating has dried, a blue ink #12 is used to print the... Figure 14A The limbal stencil pattern shown is printed onto the light-transmitting coating. After the limbal pattern has dried, green ink #13 is used to apply the... Figure 14B The inner effect pattern shown is printed onto a translucent coating using a pad printing plate. After the inner effect pattern has dried, gray ink #14 is used to apply the inner effect pattern onto the translucent coating. Figure 14C The pattern shown is printed onto a translucent coating using a pad printing plate, thereby forming... Figure 14D The pattern shown. An optional barrier layer can be printed. For example, black ink #20 can be used to print a pattern with... Figure 14C The pattern shown is applied to a translucent coating using a pad printing plate. A second translucent coating can also be printed to separate the printing layers used for the non-reverse and reverse patterns. Now, using blue ink #10 will create... Figure 15A The limbal stencil pattern shown is printed onto the light-transmitting coating. After the limbal pattern has dried, green ink #18 is used to apply the... Figure 15B The inner effect pattern shown is printed onto a translucent coating using a pad printing technique. The green ink is a different color and has a shimmering effect. After the inner effect pattern has dried, blue ink #12 is used to create a final effect. Figure 15C The pattern shown is printed onto a translucent coating using a pad printing plate, thereby forming... Figure 15D The pattern shown. The second set of printed layers can also be rotated and offset from the first set of printed layers, so that some aspects of the first pattern can be seen through the second pattern, and vice versa.

[0333] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0334] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC. Hydration is achieved by immersing the lenses in a diluent solution containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in the filler solution at 70°C for another hour. It is understood by those skilled in the art 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 ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to vials and sterilized by autoclaving at 121°C for approximately 30 minutes.

[0335] Example 7

[0336] Printed contact lenses are manufactured in a glove box where the oxygen level is maintained between 0.5% and 5%. Using a front-curved die and a base-curved die, a ring-shaped translucent coating is printed onto the front-curved die using a lab-scale pad printing machine. The front-curved die and base-curved die are designed to produce contact lenses with a dSag of less than 1.3% between non-reverse and reverse lens orientations, or with a vertex height of less than or equal to 0.020 mm from the nearest surface measurement to the eye in the reverse orientation. The front-curved die and base-curved die can be made from any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. Typically, the front-curved die and base-curved die are degassed for approximately twelve hours before use. After the translucent coating has dried, a brown ink #16 is used to print the... Figure 14A The limbal stencil pattern shown is printed onto the light-transmitting coating. After the limbal pattern has dried, green ink #18 is used to apply the... Figure 14B The inner effect pattern shown is printed onto a translucent coating using a pad printing plate. After the inner effect pattern has dried, a thin translucent layer is printed to create a depth or three-dimensional effect. After the translucent layer has dried, black ink #20 is used to apply a layer with… Figure 14CThe pattern shown is printed onto a translucent coating using a pad printing plate, thereby forming... Figure 14D The pattern shown. An optional blocking layer can be printed. A second translucent coating can also be printed to separate the printing layers used for the non-reverse and reverse patterns. Using gray ink #14 will now have... Figure 15A The limbal stencil pattern shown is printed onto the light-transmitting coating. After the limbal pattern has dried, red ink #17 is used to apply the... Figure 15B The inner effect pattern shown is printed onto a translucent coating using a pad printing technique. The red ink is a different color while maintaining the shimmering effect. After the inner effect pattern has dried, black ink #20 is used to create a final effect. Figure 15C The pattern shown is printed onto a translucent coating using a pad printing plate, thereby forming... Figure 15D The pattern shown. The second set of printed layers can also be rotated and offset from the first set of printed layers, so that some aspects of the first pattern can be seen through the second pattern, and vice versa.

[0337] Once the printed layer has dried, approximately 100 μL of RMM listed in Table B is metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE at the relative amounts listed in Table B to prepare a 52:48 (w / w) solution of reactive component and diluent. The base-curved mold is then placed on top of the front-curved mold. The tray including the mold assembly is then moved into the curing chamber at 60°C–70°C. The time between metering the RMM addition and its entry into the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. A TL03 bulb positioned above the tray is used to photopolymerize the RMM around the printed layer to achieve approximately 5 mW / cm². 2 The intensity lasted for about 4 minutes.

[0338] The printed lenses are partially demolded, with most adhering to the FC and detached from the BC. Hydration is achieved by immersing the lenses in a diluent solution containing approximately 800 ppm Tween 80 at 70°C for about one hour, followed by equilibration in the filler solution at 70°C for another hour. It is understood by those skilled in the art 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 ensure all lenses are demolded without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are then transferred to vials and sterilized by autoclaving at 121°C for approximately 30 minutes.

[0339] Example 8

[0340] For silicone hydrogel RMMs (such as senofilcon A), the binder copolymer typically differs from conventional or HEMA-based RMMs. A binder copolymer made from HEMA and silicone monomers or macromonomers is often required to stabilize the ink formulation and control RMM diffusion, such as a copolymer made from HEMA and mPDMS. This copolymer can be a random copolymer or a block copolymer. The ink formulation may also contain other polymers, such as poly(N-vinylpyrrolidone), to better control the diffusion of RMM through the printing layer. Furthermore, the method for manufacturing reversible cosmetic contact lenses from silicone hydrogel formulations is the same as that described in detail for conventional hydrogels. Specifically, two cosmetic patterns are sequentially printed on a front-curved mold using optimized silicone hydrogel ink; the silicone hydrogel RMM is dispersed onto the printed front-curved surface; a base-curved mold is placed on top of the front-curved mold; and the RMM between the two molds is cured. The front-curved mold and the base-curved mold are designed to manufacture contact lenses with a dSag of less than 1.3% between the non-reversible lens orientation and the reversible lens orientation, or with a vertex height of less than or equal to 0.020 mm measured from the nearest surface to the eye in the reversible orientation. The curing conditions for silicone hydrogel formulations typically differ from those for conventional hydrogel formulations. The lens demolding and extraction procedures for silicone hydrogel lenses also typically differ from those for conventional hydrogel lenses, requiring organic solvents or aqueous alcohol solutions.

[0341] A typical method for demolding and extracting silicone hydrogel lenses is described below: The printed lenses, with most adhering to the FC (fiberglass adhesive), are demolded by immersing them in 70% IPA for approximately one or two hours, followed by washing twice with 70% IPA, optionally twice with 25% IPA, twice with DIW (diluent-free solvent), and finally twice with a borate-buffered packaging solution. Each washing step lasts approximately 30 minutes. Those skilled in the art will recognize that the exact lens removal process can vary depending on the lens formulation and molding material, in terms of the concentration of the isopropanol aqueous solution, the number of washes with each solvent, and the duration of each step. The aim of the lens removal process is to remove all lenses without defects and to transform the network swollen by the diluent into a hydrogel swollen by the wetting solution. The lenses are then transferred to vials or packages and subsequently sterilized by autoclaving at 122°C for 30 minutes.

Claims

1. A flip-up intensifying contact lens, the flip-up intensifying contact lens comprising: a. A body comprising a first surface and a second surface opposite to the first surface, the body having a diameter, a base arc, a peripheral thickness, and a center thickness; b. wherein one or more of the diameter, the base arc, the peripheral thickness, or the center thickness are configured such that when a first orientation of the body of the first surface adjacent to the wearer's eye is compared with a second orientation of the body of the second surface adjacent to the wearer's eye, dSag is less than 1.3%; c. The main body further includes a first region corresponding to the sclera region of the eye; a second region corresponding to the limbus region of the eye; and a third region corresponding to the iris region of the eye; d. 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, the printed layers having a first design observable in the first orientation, the first design being different from a second design observable in the second orientation.

2. The reversible eye enhancement contact lens of claim 1, wherein the printed layer includes a design that uses an inner effect design pattern and an outer effect design pattern to highlight one of the irises on top of the other, wherein at least the first design or the second design is opaque.

3. The reversible eye enhancement contact lens of claim 1, wherein the printed layer comprises at least two designs as a first design and a second design, the at least two designs using an inner effect design graphic and an outer effect design graphic to highlight the iris, one on top of the other, having a certain degree of overlap and having a blocking layer therebetween.

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

5. The reversible eye enhancement contact lens according to any one of claims 1 or 3, wherein the blocking layer is at least partially opaque.

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

7. The flip-up eye enhancement contact lens of claim 1, wherein at least the first design and the second design use an inner effect design pattern and an outer effect design pattern to highlight the iris, such that the inner effect design pattern and the outer effect design pattern form a blending effect between the first design and the second design.

8. The flip-up eye enhancement contact lens of claim 7, wherein the inner effect design pattern or the outer effect design pattern that produces the fusion effect is translucent or opaque.

9. The flip-up eye enhancement contact lens of claim 7, wherein only the first design includes a fusion effect, and the first design and the second design are separated by a barrier layer.

10. The flip-up eye enhancement contact lens of claim 7, wherein at least the first design or the second design includes a limbal design pattern.

11. The flip-up eye enhancement contact lens of claim 1 or 3, wherein the printed layer further comprises one or more light-transmitting layers that produce the observable depth of the first design or the second design.

12. The reversible eye enhancement contact lens according to claim 1, wherein the reversible eye enhancement contact lens further comprises an annular light-transmitting coating base layer covering the first region, the second region and the third region.

13. The reversible eye enhancement contact lens of claim 12, wherein the reversible eye enhancement contact lens further comprises a body lens material covering the annular light-transmitting coating base layer and the first region, the second region and the third region.

14. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein the first design and the second design differ in terms of colorant, color, limbal design pattern, inner effect design pattern, outer effect design pattern, blocking layer, light-transmitting coating base layer, or a combination thereof.

15. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein the colorant comprises metal oxide pigments, coated metal oxide pigments, organic dyes, interference pigments, and combinations thereof.

16. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein one or more of the diameter, the base curve, the peripheral thickness or the center thickness are configured such that when a first orientation of the body of the wearer’s eye adjacent to at least a portion of the first surface is compared with a second orientation of the body of the wearer’s eye adjacent to at least a portion of the second surface, dSag is less than 1.2%.

17. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein one or more of the diameter, the base curve, the peripheral thickness, or the center thickness are configured such that when a first orientation of the body of the wearer’s eye, wherein at least a portion of the first surface is adjacent to the body of the wearer’s eye, is compared with a second orientation of the body of the wearer’s eye, wherein at least a portion of the second surface is adjacent to the body of the wearer’s eye, dSag is less than 1.1%.

18. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein one or more of the diameter, the base curve, the peripheral thickness or the center thickness are configured such that when a first orientation of the body of the wearer’s eye adjacent to at least a portion of the first surface is compared with a second orientation of the body of the wearer’s eye adjacent to at least a portion of the second surface, dSag is less than 1.0%.

19. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein the body exhibits an elastic modulus between 150 kPa and 1000 kPa as measured according to ANSI Z80.

20.

20. The reversible eye enhancement contact lens of claim 19, wherein the body exhibits an elastic modulus between 270 kPa and 1000 kPa as measured according to ANSI Z80.

20.

21. The reversible eye enhancement contact lens of claim 19, wherein the body exhibits an elastic modulus between 420 kPa and 1000 kPa as measured according to ANSI Z80.

20.

22. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein the diameter of the body is between 13.8 mm and 15 mm.

23. The flip-up eye enhancement contact lens of claim 22, wherein the diameter of the body is between 14.3 mm and 14.8 mm.

24. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein the base curve of the body is between 8 mm and 8.6 mm.

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

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

27. The reversible eye enhancement contact lens according to any one of claims 1 to 3, wherein the center thickness of the body is between 0.06 mm and 0.2 mm.

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

29. A pad printing method for manufacturing a reversible ophthalmic enhancement contact lens according to any one of claims 1 to 28, the pad printing method comprising the following steps: a. Print the annular translucent base material layer onto the front curved surface mold; b. Printing at least two effect layers on the annular translucent substrate layer, the effect layers comprising a limbal design pattern, an inner effect design pattern, an outer effect design pattern, and combinations thereof; c. Print at least one barrier layer between the effect layers; d. Print at least one other annular translucent base layer between the effect layers; e. Dispense the reactive monomer mixture of the body lens material onto the front curved surface mold; f. Curing the reactive monomer mixture of the body lens material around the light-transmitting base layer and the effect layer; g. Remove the mold from the lens; h. Extract the lens with a solvent; as well as i. Sterilize the lens by high-pressure sterilization. The effect layer is in the form of at least partially overlapping printed layers, the printed layers having a first design that can be observed in the first orientation, the first design being different from a second design that can be observed in the second orientation.

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

31. A flip-up intensifying contact lens, the flip-up intensifying contact lens comprising: a. Main body b. The body includes a first surface and a second surface opposite to the first surface, and the body has a diameter, a base arc, a thickness profile, and an edge profile; c. wherein one or more of the edge profile and the diameter, the base arc or the thickness profile are configured such that when the lens is in a reverse orientation adjacent to the wearer’s eye in at least a portion of the second surface, the vertex height measured from the edge vertex to the nearest surface of the eye is less than or equal to 0.020 mm. d. The main body further includes a first region corresponding to the sclera region of the eye; a second region corresponding to the limbus region of the eye; and a third region corresponding to the iris region of the eye; e. 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, the printed layers having a first design observable in a first orientation of the body of the wearer’s eye at least a portion of the first surface, the first design being different from a second design observable in a second orientation of the body of the wearer’s eye at least a portion of the second surface.

32. The reversible eye enhancement contact lens according to claim 31, wherein the reversible eye enhancement contact lens further comprises an annular light-transmitting coating base layer covering the first region, the second region and the third region.

33. The reversible eye enhancement contact lens according to claim 32, wherein the reversible eye enhancement contact lens further comprises a body lens material covering the annular light-transmitting coating base layer and the first region, the second region and the third region.

34. The reversible eye enhancement contact lens according to 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 terms of colorant, color, limbal design pattern, inner effect design pattern, outer effect design pattern, blocking layer, light-transmitting coating base layer or a combination thereof.

35. The reversible eye enhancement contact lens according to any one of claims 31 to 33, wherein the colorant comprises metal oxide pigments, coated metal oxide pigments, organic dyes, interference pigments, and combinations thereof.

36. The reversible eye enhancement contact lens according to any one of claims 31 to 33, wherein the edge profile and one or more of the diameter, the base arc or the thickness profile are configured such that when a first orientation of the body of the wearer’s eye with at least a portion of the first surface adjacent to the body of the wearer’s eye is compared with a second orientation of the body of the wearer’s eye with at least a portion of the second surface adjacent to the body of the wearer’s eye, dSag is less than 1.2%.

37. The reversible eye enhancement contact lens according to any one of claims 31 to 33, wherein one or more of the edge profile and the diameter, the base arc or the thickness profile are configured such that when a first orientation of the body of the wearer’s eye with at least a portion of the first surface adjacent to the body of the wearer’s eye is compared with a second orientation of the body of the wearer’s eye with at least a portion of the second surface adjacent to the body of the wearer’s eye, dSag is less than 1.1%.

38. The reversible eye enhancement contact lens according to any one of claims 31 to 33, wherein the edge profile and one or more of the diameter, the base arc or the thickness profile are configured such that when a first orientation of the body of the wearer’s eye with at least a portion of the first surface adjacent to the body of the wearer’s eye is compared with a second orientation of the body of the wearer’s eye with at least a portion of the second surface adjacent to the body of the wearer’s eye, dSag is less than 1.0%.

39. The reversible eye enhancement contact lens according to any one of claims 31 to 33, wherein the body exhibits an elastic modulus between 150 kPa and 1000 kPa as measured according to ANSI Z80.

20.

40. The reversible eye enhancement contact lens of claim 39, wherein the body exhibits an elastic modulus between 270 kPa and 1000 kPa as measured according to ANSI Z80.

20.

41. The reversible eye enhancement contact lens of claim 40, wherein the body exhibits an elastic modulus between 420 kPa and 1000 kPa as measured according to ANSI Z80.

20.

42. The flip-up eye enhancement contact lens according to any one of claims 31 to 33, wherein the diameter of the body is between 13.8 mm and 15 mm.

43. The flip-up eye enhancement contact lens of claim 42, wherein the diameter of the body is between 14.3 mm and 14.8 mm.

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

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

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

47. The reversible eye enhancement contact lens according to any one of claims 31 to 33, wherein the edge profile of the body is between 0.06 mm and 0.2 mm.

48. The flip-up eye enhancement contact lens of claim 47, wherein the edge profile of the body is between 0.1 mm and 0.2 mm.

49. A pad printing method for manufacturing a reversible ophthalmic enhancement contact lens according to any one of claims 31 to 48, the pad printing method comprising the following steps: a. Print the annular translucent base material layer onto the front curved surface mold; b. Printing at least two effect layers on the annular translucent substrate layer, the effect layers comprising a limbal design pattern, an inner effect design pattern, an outer effect design pattern, and combinations thereof; c. Print at least one barrier layer between the effect layers; d. Print at least one other annular translucent base layer between the effect layers; e. Dispense the reactive monomer mixture of the body lens material onto the front curved surface mold; f. Curing the reactive monomer mixture of the body lens material around the light-transmitting base layer and the effect layer; g. Remove the mold from the lens; h. Extract the lens with a solvent; as well as i. Sterilize the lens by high-pressure sterilization. The effect layer is in the form of at least partially overlapping printed layers, the printed layers having a first design that can be observed in the first orientation, the first design being different from a second design that can be observed in the second orientation.

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

51. A kit comprising at least one pair of reversible eye enhancement contact lenses according to any one of the preceding claims, wherein each lens has a first design and a second design, the first design providing a subtle variation in the observed design relative to the observed eye, and the second design providing a significant variation in the observed design relative to the observed eye.

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