Concave contact lenses

Abstract

A contact lens having dimples on a posterior surface and a casting mold and an injection molded insert for making the same are described. The contact lens comprises a posterior surface having an optic zone, a peripheral zone, and a circumferential edge, wherein dimples are located in the peripheral zone and may comprise at least 1000 dimples.

Description

Technical Field

[0001] The present invention relates to contact lenses and molds and mold inserts for forming contact lenses. More particularly, the present invention relates to the use of dimples on contact lenses and methods of making the same. Contact lenses with dimples can be considered concave contact lenses. Background Art

[0002] A healthy eye contains tears localized on the epithelium. Tears are primarily water and contain additional components that protect the eye and ocular surface from the effects of light and pollution (e.g., mucoids, lipids, and various antioxidant molecules such as enzymes and vitamins).

[0003] Contact lenses provide vision correction and / or enhancement, cosmetic enhancement, and / or both vision correction and cosmetic enhancement. Contact lenses are preferably designed to ensure that sufficient concentrations of oxygen are supplied to the eye (specifically, the cornea) to promote corneal health. However, current contact lenses can reduce the flow of nutrient-rich tears to the cornea. This reduced flow of tears can adversely affect ocular health and / or lead to general wearer discomfort.

[0004] Therefore, it would be desirable to provide a contact lens that can maintain many, if not all, of the benefits of a contact lens and still improve wearer comfort. Additionally, there is a need in the industry for a contact lens that can improve or increase the retention of tear fluid between the lens and the cornea. Summary of the invention

[0005] A feature of the present invention is to provide a contact lens that improves or increases the retention of tear fluid between the lens and the cornea when the contact lens is worn.

[0006] It is an additional feature of the present invention to provide a contact lens that improves or increases the retention of tear fluid between the lens and the cornea and is comfortable to wear on the eye for extended periods of time.

[0007] It is a further feature of the present invention to provide a contact lens that improves or increases the retention of tears between the lens and the cornea and still has the same post-blink movement on the eye.

[0008] Additional features and advantages of the present invention will be described in part in the following description, and will be apparent from the description, or may be learned through practice of the present invention. The objects and other advantages of the present invention will be realized and obtained through the elements and combinations particularly pointed out in the description and appended claims.

[0009] To achieve these and other advantages, and in accordance with the purposes of the invention, as embodied and broadly described herein, the invention relates in part to a contact lens. The contact lens comprises a posterior surface having an optic zone, a peripheral zone, and a circumferential edge. The peripheral zone comprises dimples numbering at least 1000 dimples. The dimples provide a fill volume of at least 0.01 μl and have up to 80% dimple coverage based on the total surface area of ​​the posterior surface.

[0010] The present invention further relates to a mold for casting of contact lenses. The mold comprises a dome pattern which is a negative pattern of a dimple pattern of dimples. The dimple pattern is formed on a peripheral region of a contact lens molded therein. The number of dimples is at least 1000 dimples. The dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80%.

[0011] In addition, the present invention relates to an injection molded insert for forming a mold for a cast mold of a contact lens. The injection molded insert comprises a dimple pattern of dimples formed on a peripheral zone of a cast molded contact lens. The number of the dimples is at least 1000 dimples. The dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80%.

[0012] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed.

[0013] The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate certain features of the invention and together with the description, serve to explain the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 is a view (not to scale) of the back side of an example of a concave contact lens.

[0015] Figure 2 is a view of the back side of another example of a concave contact lens.

[0016] Figure 3 is a perspective view depicting an example of two adjacent dimples that may be present in a contact lens of the present invention.

[0017] Figure 4 is a cross-sectional diagram depicting an example of two adjacent dimples in a contact lens.

[0018] Figure 5 is a view of the back side of another example of a concave contact lens.

[0019] Figure 6 is a view of the back side of another example of a concave contact lens.

[0020] Figure 7 is a view of the back side of another example of a concave contact lens.

[0021] Figure 8 is a view of the back side of another example of a concave contact lens.

[0022] Fig. 9 is a view of the back side of another example of a concave contact lens.

[0023] Fig. 10A is a view of the back side of an example of a concave contact lens and shows a cluster of dimples.

[0024] Fig. 10B Display Formation Fig. 10A An enlarged depiction of a cluster of dimples in a concave portion of a contact lens.

[0025] Fig.11A is a detailed cross-sectional view depicting the dimple pattern of a mold insert.

[0026] Fig. 11B is a detailed cross-sectional view depicting the dome pattern of the male mold component.

[0027] Fig. 11C is a detailed cross-sectional diagram depicting the dimple pattern of a concave contact lens. DETAILED DESCRIPTION

[0028] Contact lenses with dimples and casting molds and injection molded inserts for making contact lenses and methods of making concave contact lenses are described herein. One or more contact lenses with dimples are sometimes referred to herein as concave contact lenses.

[0029] In the present invention, the concave contact lenses preferably retain tear fluid within the concave recess, and thereby retain tear fluid between the contact lens and the eye, which may improve lens comfort and ocular health for at least some wearers.

[0030] Reference herein to an "example" or "specific example" or "aspect" or "embodiment" or similar phrases is intended to introduce a feature or several features of a concave contact lens or components thereof or a method of making a concave contact lens (depending on the context) that can be combined with any combination of previously described or subsequently described examples, aspects, embodiments (i.e., features), unless the particular combination of features is mutually exclusive or if the context indicates otherwise. In addition, as used in this specification, the singular forms "a", "an", and "the" include plural referents (e.g., at least one or more) unless the context clearly indicates otherwise. Thus, for example, reference to "a contact lens" includes a single lens as well as two or more of the same or different lenses.

[0031] A concave contact lens has the ability to increase the amount of tear fluid that can be held between the lens and the cornea, which can lead to increased comfort and / or eye health. One or more dimples have the ability to create a reservoir. The reservoir can increase the volume of tears behind the lens, help carry more packaging solution and / or comfort agent from the lens packaging to the eye, help retain tears behind the lens and / or help retain a comfort agent if a comfort agent is dispensed onto the eye with a contact lens already present, reduce friction between the lens and the eye, reduce the area of ​​the lens that contacts the eye, reduce nerve contact with the lens, reduce variations in osmotic pressure, and / or improve surface wettability, and / or any combination thereof.

[0032] The dimples may be considered as indentations or recesses located on the posterior surface. The dimples may be further defined by their diameter, pitch (center-to-center distance between two dimples), and depth, which are described in more detail below. It should be understood that for each of the measured parameters, the parameters may apply to dry contact lenses or may apply to hydrated (e.g., fully hydrated) contact lenses. When comparing a dry contact lens having the parameters to the same contact lens that is fully hydrated, the parameters such as diameter, pitch, and / or depth of the hydrated contact lens may be at least 1%, at least 2.5%, at least 5%, at least 10% higher than the dry contact lens. The difference may be that the hydrated contact lens may be from about 1% to 25%, or from 5% to 20%, or from 10% to 25% higher than the dry contact lens.

[0033] As an option, the dimples may be considered micro-dimples as opposed to dimples.

[0034] The dimple diameter (for dry or hydrated lenses) may be at least about 5 μm, 10 μm, 15 μm, 20 μm, 25 μm, or 30 μm up to about 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, or 100 μm. For example, the dimple diameter may be from 5 μm to 100 μm, or from 5 μm to 70 μm, or from 5 μm to 50 μm, or from 5 μm to 30 μm, or from 10 μm to 50 μm, and the like. The size may be considered an average dimple diameter. As an option, the dimples may include a narrow distribution of dimple diameters, such that each dimple diameter is within about 20%, 15%, 10%, 5%, or 1% of the average diameter. For example, the dimples may each have a dimple diameter within about 5 μm, or within 2.5 μm, or within 1 μm of the average dimple diameter.

[0035] The dimple diameters of the dimples may be uniform relative to each other or may include a combination of more than one dimple diameter. For example, the plurality of dimples may have two groups of dimples, one group having a first dimple diameter and a second group having a second dimple diameter. The average dimple diameter between the first group and the second group may be, for example, any diameter as provided above. The average dimple diameter between the first group and the second group may vary by at least 5%, at least 10%, at least 20%, at least 50%, for example, from 5% to 200% or from 5% to 100% or from 10% to 75%. Furthermore, as an option, the plurality of dimples may have more than two groups of dimples, for example, three groups or four or more groups having different average dimple diameters. When there are two or more groups of dimples, the configuration of the dimples may be random, or arranged in any desired pattern (alternating regions or sections of each group (one annular region of one group of dimples and a second annular region of another group of dimples), etc.). The dimples may comprise a bimodal or multimodal distribution of dimples, wherein the dimples comprise a combination of more than one type of dimples, each type having at least a different average dimple diameter.

[0036] The dimple pitch is the distance between the dimple centers of two dimples that are close to each other (adjacent to each other). Figure 3 , the ends of line b are located at the centers of two adjacent dimples (20) x and y. The length of line b is the pitch.

[0037] With respect to dimple pitch, the dimple pitch (for dry or hydrated lenses) may be at least about 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm up to about 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, or 180 μm. For example, the dimple pitch may be from about 10 μm to about 125 μm or from about 15 μm to about 90 μm. The size may be considered an average dimple pitch. As an option, the dimples may include a narrow dimple pitch distribution such that each dimple pitch is within about 20%, 15%, 10%, 5%, or 1% of the average dimple pitch.

[0038] The dimple pitches may be uniform relative to each other.

[0039] As an option, the dimple pitch may be non-uniform. For example, the plurality of dimples may have two or more sets or groups of dimple pitches due to the arrangement of the dimples and the spacing therebetween. When there is more than one set or group of dimple pitches, the dimple pitch of each set or group may vary by at least 5%, at least 10%, at least 20%, at least 50%, such as from 5% to 100% or from 10% to 75%.

[0040] When there is more than one dimple pitch, the dimples may be arranged randomly, or in any desired pattern (alternating areas or sections of each group (one annular area of ​​one group of dimples and a second annular area of ​​another group of dimples), etc.) when there are two or more groups of dimples.

[0041] In another example, the distribution of dimples throughout the peripheral region may be quasi-random. In this example, the pitch between each pair of dimples is between a specific minimum value and a specific maximum value, but is otherwise random. For example, the quasi-random distribution of dimples may include dimples distributed throughout the peripheral region, wherein the pitch within each dimple is randomly distributed between values ​​of 20 μm and 40 μm.

[0042] The random or quasi-random distribution of the dimples in or near the optic zone of the contact lens can reduce or avoid the possibility of visual disturbances such as nighttime halos or glare. In one example, all dimples within 5.5 mm or 5 mm or 4.5 mm of the center of the contact lens (i.e., the geometric center of the optic zone) have a quasi-random distribution.

[0043] In a further example, the contact lens includes dimples having a quasi-random distribution positioned within 5 mm of the center of the contact lens and dimples having a uniform distribution positioned at least 5.5 mm from the center of the contact lens.

[0044] As an option, the contact lens may not have a dimple located within 5.5 mm or 5 mm or 4.5 mm of the center of the contact lens (ie, the geometric center of the optic zone).

[0045] For dimples having parabolic, cylindrical, or other common dimple shapes, dimple depth (for dry or hydrated lenses) can generally be measured based on the length (or height) along the central axis of the dimple. For example, Figure 3 An example of one type of dimple is shown and the dimple depth will be Figure 3 The length of the line indicated by "a" in .

[0046] The dimple depth may be at least about 2 μm, 5 μm, 10 μm, 15 μm and up to about 30 μm, 40 μm, 50 μm or 60 μm. For example, the dimple depth may be from about 2 μm to about 60 μm, or from about 5 μm to about 40 μm, or from about 10 μm to about 30 μm. The size may be considered as an average dimple depth. As an option, the dimples may include a narrow distribution of dimple depths such that each dimple depth is within about 20%, 15%, 10%, 5% or 1% of the average dimple depth.

[0047] The dimple depths may be uniform relative to each other or may include a combination of more than one dimple depth. For example, the plurality of dimples may have two groups of dimples, one group having a first dimple depth and a second group having a second dimple depth. The average dimple depth between the first group and the second group may be, for example, any depth as provided above. The average dimple depth between the first group and the second group may vary by at least 5%, at least 10%, at least 20%, at least 50%, for example from 5% to 100% or from 10% to 75%. In addition, as an option, the plurality of dimples may have more than two groups of dimples, for example, three groups or four or more groups with different average dimple depths. When there are two or more groups of dimples, the arrangement of the dimples may be random, or arranged in any desired pattern (alternating regions or sections of each group (one annular area of ​​one group of dimples and a second annular area of ​​another group of dimples), etc.). The dimples may include a bimodal or multimodal distribution of dimples, wherein the dimples include a combination of more than one type of dimples, each type having at least a different average dimple depth.

[0048] As an option, some or all of the dimples may have an average dimple depth to average diameter ratio of at least 0.25, or at least 0.3, or at least 0.4, or at least 0.5. For example, this ratio may be from 0.25 to 2.5, or from 0.25 to 2, or from 0.25 to 1.5, or from 0.3 to 2, or from 0.3 to 1.5, or any other range.

[0049] As an option, some or all of the dimples may have an average dimple intra-pitch to average diameter ratio of at least 1.25, or at least 1.5, or at least 2, or at least 2.5, such as from about 1.25 to 4, or from about 1.25 to 3.5, or from 2 to 4 or other ranges.

[0050] The dimples may have any shape. The shape may be characterized by taking a cross-section of the dimple through the central axis. For example, at least a portion or all of the dimple may have a shape that is circular, elliptical, triangular, rectangular, gaussian, parabolic, or irregular or other geometric shape. For example, Figure 3 Two dimples (20) are illustrated, each having a parabolic shape. In addition, the dimples have a top view having a shape that may or may not be the same as the cross-sectional view. This top view may be circular, elliptical, triangular, rectangular, irregular, and the like. Multiple dimples may have the same shape or portions of the dimples may have one or more different shapes. For example, a contact lens may have two sets of dimple shapes. When there are two or more sets of dimples, the arrangement of the dimples may be random, or configured in any desired pattern (alternating regions or sections of each set (one annular region of one set of dimples and a second annular region of another set of dimples), etc.). The dimples may include a bimodal or multimodal distribution of dimples, wherein the dimples include a combination of more than one type of dimples, each type having at least a different shape.

[0051] The dimple has an edge around the opening of the dimple. As described in more detail below, the sharpness of the edge may be a result of the manner in which the dimple is formed. Using the present invention, some or all of the edges of the dimple may be smooth. As an option, the edge may be considered rounded or curved rather than angled. Figure 4 Depicted are two adjacent dimples (20) x and y, where dimple x has a curved edge (21) and dimple y has an angled edge (22). Smoother edges can further increase wearer comfort. As a further example, edge (21) of a dimple (20) is an edge defining the mouth of the dimple (20), such as Figure 4 The smooth edge (21) may be rounded so that the edge is not approached perpendicular to the rear surface (17). The smooth edge may be produced by using a laser to create a dimple in the mold insert. The mold insert and its method of production are described in more detail below.

[0052] The dimples may also be characterized by a "total fill volume", which is the amount of fluid that can be contained inside all of the dimples present on a single lens. The total fill volume may be at least 0.01 μl, 0.02 μl, 0.025 μl, 0.05 μl, 0.1 μl, 0.15 μl, 0.2 μl, 0.3 μl, or 0.4 μl up to about 0.5 μl, 0.6 μl, 0.7 μl, 0.8 μl, 0.9 μl, or 1 μl or more. The fill volume V of each individual dimple having a parabolic shape may be determined by the equation V = 1 / 2π·r 2 a calculation, where reference Figure 3 , a is the length of the central axis of the dimple (i.e., the dimple depth), and r is the radius of the opening of the dimple. The thickness of the tear film behind a contact lens has been shown to be approximately 2.3 μm (Nichols and King-Smith, Invest Ophthalmol Vis Sci (2003) 44(1): 68-77). For a lens having approximately 210 mm 2 For a contact lens with a back surface area of ​​100 μl, the volume of tears behind the lens is about 0.5 μl. Due to the total filling volume of the dimples, the concave contact lens has the ability to hold an increased volume of tears or other fluids compared to the control lens. As used herein, a "control lens" refers to a contact lens that has no dimples present in the lens, but is otherwise identical to the contact lens to which it is compared (i.e., the test lens) (this is because it is made using the same contact lens formulation (sometimes referred to herein as a "polymerizable composition") and subjected to the same manufacturing procedures).

[0053] The percentage increase in volume of a concave contact lens compared to a control lens can be from about 5%, 10%, 20%, 30%, 40%, 50% or 60% up to about 70%, 80%, 90%, 100%, 120%, 150% or 200% or more.

[0054] The dimples present on the contact lens may be any number. Preferably, the number of dimples is at least about 1,000 dimples, for example, on the posterior surface. For example, the total number can be from about 1,000 to 1,000,000, or from about 2,000 to 1,000,000, or from about 5,000 to 1,000,000, or from about 10,000 to about 1,000,000, or from about 15,000 to about 1,000,000, or from about 20,000 to 1,000,000, or from about 30,000 to 1,000,000, or from about 40,000 to 1,000,000, or from about 50,000 to 1,000,000, or from about 10,000 to 500,000, or from about 10,000 to 250,000, or from about 10,000 to 200,000, and the like. These numbers may be, for example, the total dimples on the posterior surface only.

[0055] As an option, none of the dimples on the surface touches any other dimple. In other words, the pitch within each dimple of the contact lens is greater than 1.

[0056] As an option, the dimples on the contact lens may have dimples only in the (posterior) peripheral zone. Figure 1 Depicts the back surface of a contact lens (10) having a central optic zone (11), a circumferential edge (12), and a peripheral zone (13) between the optic zone and the circumferential edge. In this configuration, the entire dimple (20) is contained in the peripheral zone.

[0057] As an option, the dimples on the contact lens may have dimples in the peripheral zone, but may have areas near the circumferential edge without dimples. Figure 2 , a contact lens (10) is shown having an optical zone (11) without dimples, a circumferential edge (12), and a peripheral zone including two annular portions, an outer annular portion (15) without dimples and an inner annular portion (16) containing dimples (20). The outermost portion of the peripheral zone (13) having dimples (20) may be at a distance from the circumferential edge (12) of, for example, 0.01 mm to 2.0 mm, or 0.25 mm to 1.5 mm, or 0.5 mm to 2.0 mm, or other distances. The chord distance ( Figure 2The distance 'd' in the contact lens may be from about 2 mm to 6 mm, such as from 2 mm to 5 mm or from 2 mm to 4 mm. In one example, all dimples on the contact lens are positioned at least 4.5 mm or 5 mm or 5.5 mm from the center of the contact lens (i.e., the center of the optic zone) to reduce or avoid possible visual disturbances such as night halos or glare.

[0058] A concave contact lens can be further characterized by dimple coverage. The dimple coverage is the percentage of dimple coverage relative to the total surface area of ​​the surface containing the dimples (e.g., the posterior surface), where the total surface area is considered to be the same as the surface area of ​​the corresponding surface of the control lens (i.e., the posterior surface). In other words, the surface area of ​​each dimple is not included in the total surface area, but the area of ​​the opening of each dimple is included in the total surface area (i.e., in the case of a dimple with a circular opening, π·r 2 ). The dimple coverage on the side of the eyeglass may be at least about 4%, 5%, 10%, 15%, 20%, or 30% up to about 40%, 50%, 60%, 70%, or 80% or more of the total area of ​​the side of the eyeglass (e.g., the rear surface area). For example, referring to Figure 1 If the peripheral zone (13) comprises 60% of the posterior surface area of ​​the contact lens (10) and 40% of the surface area of ​​the peripheral zone comprises dimples (20), then the dimple coverage on the posterior surface of the lens will be 24%.

[0059] Concave contact lenses can also be characterized by packing density. Packing density is the percentage of dimples within the concave or textured area. The packing density can be at least about 6%, 10%, 15%, 20%, or 30% up to about 40%, 50%, 60%, 70%, 80%, or 90% of this area. Therefore, again referring to Figure 1 , if 40% of the peripheral region (13) comprises dimples (20), then the packing density of the dimple area is 40%.

[0060] As an option, one or more parameters of dimples (as described herein) may vary (e.g., taper) toward the circumferential edge and / or toward the optic zone. For example, the diameter and depth of the dimples may decrease toward the circumferential edge and toward the optic zone (or vice versa), while the dimple pitch may increase toward the circumferential edge and toward the optic zone (or vice versa). For example, Figure 5 A contact lens (10) is depicted that includes dimples (20) in its peripheral region. A first set of dimples surrounds the optic zone (11), wherein each dimple in the first set has a diameter d1. A second set of dimples is positioned just inside the circumferential edge (12), wherein each dimple in the second set has a smaller diameter d2. Figure 6A contact lens (10) is depicted having dimples with a smaller diameter d2 in a first zone surrounding an optic zone (11) and a third zone within a circumferential edge (12), wherein dimples in a second zone positioned between the first and third zones have a larger diameter d1.

[0061] As an option, the peripheral region may include one or more areas without dimples. Figure 7 A contact lens (10) is depicted having an optic zone (11) without dimples, a circumferential edge (12), and a peripheral zone comprising an inner annular portion (16) containing dimples, an intermediate annular portion (18) without dimples, and an outer annular portion (17) containing dimples (20). In other words, the peripheral zone may include an outer ring of dimples and an inner ring of dimples separated by a region without dimples. Alternatively, as Figure 8 As depicted in FIG. 1 , the peripheral region may include only the outer annular portion (17) containing the dimples (20) adjacent the circumferential edge (12), or as Fig. 9 Depicted in FIG. 1 , only the inner annular portion ( 16 ) of the dimple ( 20 ) adjacent to the optic zone ( 11 ) is included.

[0062] As an option, when watching e.g. Figure 1 When the surface of the eyeglass with dimples is shown in FIG. 1 , there is no overall discernible geometric shape or pattern created by an overall common view of the dimples. For example, the dimples do not have the appearance of a spoke pattern, a line pattern, or a ring pattern and have an appearance of being randomly or evenly dispersed around the peripheral area. For example, as Figure 1 , the view as a whole does not provide any discernible geometry based on the dimple locations.

[0063] In one example, the dimples of a concave contact lens may be composed of many clusters of dimples, wherein each cluster forms an ordered pattern, such as a hexagonal shape, a cubic shape, a polygonal shape, and the like. In this example, there may be no overall discernible geometric shape created by the clusters of dimples. For example, Fig. 10A A contact lens (10) comprising a dimple cluster (23) is depicted, wherein a common view of all the dimples of the contact lens has no overall discernible geometric shape. The dimples appear to be evenly distributed on the lens. Fig. 10B Depiction Fig. 10A A hexagonal arrangement of dimple clusters (23) is shown in FIG. 1 , wherein a single cluster of dimples comprises a central dimple (20) and six peripheral dimples arranged as if at the vertices of a hexagon.

[0064] As used herein, "substantially the same" means within 15%, within 10%, within 5%, or within 1% of one measured property or two or more measured properties, and the measurement of "same" is within the error measurement of the property measurement.

[0065] Due to the dimple parameters and / or its placement, the dimple contact lens can have the same or substantially the same equilibrium water content (EWC) as compared to a control lens after swelling in an aqueous fluid.

[0066] Due to the dimple parameters and / or its placement, the concave contact lens can have the same or substantially the same coefficient of friction (CoF) as the control lens.

[0067] Due to the dimple parameters and / or its placement, the concave contact lens can have the same or substantially the same oxygen permeability as the control lens.

[0068] Compared to a control lens, a concave contact lens can generally have a smaller overall contact area with the eye (e.g., surface area in contact with the cornea). For example, the reduced contact area can be a reduction of at least 2%, or at least 5%, at least 10%, at least 15%, or at least 25%, such as from about 5% to 25%, or from 5% to 15%, of the total surface area that touches the posterior surface area of ​​the eye (or cornea).

[0069] The concave contact lens may have the same or substantially the same post-blink movement (PBM) on the eye compared to the control lens. In one example, the concave contact lens may have a PBM amount that is no greater than the PBM amount of the control lens.

[0070] The concave contact lens can have a downward gaze movement on the eye that is the same or substantially the same as the downward gaze movement of the control glasses or less than the downward gaze movement of the control glasses. In one example, the concave contact lens can have a downward gaze movement on the eye that is no greater than the downward gaze movement of the control glasses.

[0071] To measure the amount of PBM, a slit lamp microscope equipped with an eyepiece graticule can be used. For example, measurements are taken at a magnification of X10. The amount of PBM is measured immediately after a blink with the eyeglass wearer looking at the primary gaze position. The measurement is taken by observing the lower edge of the glasses. The measurements are recorded in millimeters (to the nearest 0.05 mm) using a vertically oriented eyepiece graticule.

[0072] The concave contact lens can be made of any lens material conventional in the art. The contact lens can be a hard or soft contact lens. Preferably, the contact lens is a hydrogel contact lens. The contact lens can preferably be made of or be a silicone hydrogel material.

[0073] The polysilicone hydrogel material is usually formed by curing a polymerizable composition (i.e., a monomer mixture) including at least one siloxane monomer and at least one hydrophilic monomer or at least one hydrophilic polymer or a combination thereof. "Monomer" refers to a molecule that includes a polymerizable carbon-carbon double bond (i.e., a polymerizable group) and is capable of reacting with the same or different other molecules containing polymerizable groups to form a polymer or copolymer. The term monomer encompasses polymerizable prepolymers and macromolecular monomers, and there is no size limitation of the monomer unless otherwise indicated. The monomer may include a single polymerizable carbon-carbon double bond or more than one polymerizable group, and therefore has cross-linking functionality. As used herein, the term "siloxane monomer" is a monomer containing at least one Si-O group. Siloxane monomers that can be used in contact lens compositions are well known in the art (e.g., see U.S. Pat. No. 8,658,747 and U.S. Pat. No. 6,867,245). (All patents and publications mentioned herein and throughout are incorporated by reference in their entirety.) In some examples, the polymerizable composition can have a total amount of siloxane monomers of at least 10 wt.%, 20 wt.%, or 30 wt.% up to about 40 wt.%, 50 wt.%, 60 wt.%, or 70 wt.%. Unless otherwise specified, as used herein, given weight percentages (wt.%) of components of the polymerizable composition are relative to the total weight of all polymerizable ingredients and IPN polymers (as further described below) in the polymerizable composition. The weight of the polymerizable composition contributed by components that are not incorporated into the final contact lens product (e.g., diluent) is not included in the wt.% calculation.

[0074] In a particular example, the polymerizable composition includes a hydrophilic vinyl monomer. As used herein, a "hydrophilic vinyl monomer" is any siloxane-free (i.e., Si-O-free) hydrophilic monomer having a polymerizable carbon-carbon double bond (i.e., vinyl) present in a non-acryloyl portion of its molecular structure, wherein the carbon-carbon double bond of the vinyl is less reactive than the carbon-carbon double bond present in a polymerizable methacrylate group under free radical polymerization. As used herein, the term "acryloyl" refers to a polymerizable group present in acrylate, methacrylate, acrylamide, etc. Therefore, although carbon-carbon double bonds are present in acrylate and methacrylate groups, as used herein, such polymerizable groups are not considered vinyl. In addition, as used herein, if at least 50 grams of the monomer is completely soluble in 1 liter of water (i.e., ~5% soluble in water) at 20°C as determined visibly using a standard shake bottle method, the monomer is "hydrophilic". In various examples, the hydrophilic vinyl monomer is N-vinyl-N-methylacetamide (VMA), or N-vinyl pyrrolidone (NVP), or 1,4-butanediol vinyl ether (BVE), or ethylene glycol vinyl ether (EGVE), or diethylene glycol vinyl ether (DEGVE), or any combination thereof. In one example, the polymerizable composition includes at least 10 wt.%, 15 wt.%, 20 wt.%, or 25 wt.% up to about 45 wt.%, 60 wt.%, or 75 wt.% of the hydrophilic vinyl monomer. As used herein, a given weight percentage of a particular class of components (e.g., hydrophilic vinyl monomers, siloxane monomers, or the like) in a polymerizable composition is equal to the sum of the wt.% of each ingredient in the composition that falls within that class. Thus, for example, a polymerizable composition comprising 5 wt.% of BVE and 25 wt.% of NVP and no other hydrophilic vinyl monomers is said to include 30 wt.% of the hydrophilic vinyl monomer. In one example, the hydrophilic vinyl monomer is a vinylamide monomer. Exemplary hydrophilic vinylamide monomers are VMA and NVP. In a specific example, the polymerizable composition includes at least 25 wt.% of the vinylamide monomer. In a further specific example, the polymerizable composition includes from about 25 wt.% to up to about 75 wt.% of VMA or NVP or a combination thereof. Additional hydrophilic monomers that may be included in the polymerizable composition are N,N-dimethylacrylamide (DMA), 2-hydroxyethyl methacrylate (HEMA), ethoxyethyl methacrylamide (EOEMA), ethylene glycol methyl ether methacrylate (EGMA), and combinations thereof.

[0075] In addition or as an alternative to a hydrophilic monomer, the polymerizable composition may include a non-polymerizable hydrophilic polymer, which results in a polymer lens body including an interpenetrating polymer network (IPN), wherein the non-polymerizable hydrophilic polymer interpenetrates the silicone hydrogel polymer matrix. In this example, the non-polymerizable hydrophilic polymer is referred to as an IPN polymer, which is used as an internal wetting agent in a contact lens. In contrast, the polymer chains within the silicone hydrogel network formed by the polymerization reaction of the monomers present in the polymerizable composition are not considered to be IPN polymers. The IPN polymer may be a high molecular weight hydrophilic polymer, for example, from about 50,000 to about 500,000 Daltons. In a particular example, the IPN polymer is polyvinyl pyrrolidone (PVP). In other examples, the polymerizable composition is substantially free of polyvinyl pyrrolidone or other IPN polymers.

[0076] The polymerizable composition may additionally include at least one crosslinking agent. As used herein, a "crosslinking agent" is a monomer having at least two polymerizable groups. Thus, a crosslinking agent may react with functional groups on two or more polymer chains in order to bridge one polymer to another polymer. The crosslinking agent may include an acryloyl or vinyl group, or both an acryloyl and vinyl group. In some instances, the crosslinking agent is free of a siloxane moiety, i.e., it is a non-siloxane crosslinking agent. Various crosslinking agents suitable for use in silicone hydrogel polymerizable compositions are known in the art (e.g., see U.S. Pat. No. 8,231,218, which is incorporated herein by reference). Examples of suitable crosslinking agents include, but are not limited to, lower alkylene glycol di(meth)acrylates, such as triethylene glycol dimethacrylate and diethylene glycol dimethacrylate; poly(lower alkylene) glycol di(meth)acrylates; lower alkylene di(meth)acrylates; divinyl ethers, such as triethylene glycol divinyl ether, diethylene glycol divinyl ether, 1,4-butanediol divinyl ether, and 1,4-cyclohexanedimethanol divinyl ether; bisvinyl sulfone; divinylbenzene and trivinylbenzene; trimethylolpropane tri(meth)acrylate; pentaerythritol tetra(meth)acrylate; bisphenol A di(meth)acrylate; methylenebis(meth)acrylamide; triallyl phthalate; 1,3-bis(3-methacryloxypropyl)tetramethyldisiloxane; diallyl phthalate; and combinations thereof.

[0077] As will be appreciated by those skilled in the art, the polymerizable composition may include additional polymerizable or non-polymerizable ingredients conventionally used in contact lens formulations, such as one or more of a polymerization initiator, a UV absorber, a colorant, a deoxidizer, a chain transfer agent, or the like. In some examples, the polymerizable composition may include an amount of an organic diluent to prevent or minimize phase separation between the hydrophilic and hydrophobic components of the polymerizable composition, so that optically clear lenses are obtained. Diluents commonly used in contact lens formulations include ethyl alcohol, ethanol, and / or other alcohols. In other examples, the polymerizable composition is free or substantially free (e.g., less than 500 ppm) of organic diluent. In such examples, the use of siloxane monomers containing hydrophilic moieties (e.g., polyethylene oxide groups, pendant hydroxyl groups, or other hydrophilic groups) may eliminate the need to include a diluent in the polymerizable composition. Non-limiting examples of these and additional ingredients that may be included in the polymerizable composition are provided in U.S. Pat. No. 8,231,218.

[0078] Non-limiting examples of silicone hydrogels that can be used include comfilcon A, fanfilcon A, stenfilcon A, senofilcon A, senofilcon C, somofilcon A, narafilcon A, delefilcon A, narafilcon A, lotrafilcon A, lotrafilcon B, balafilcon A, samfilcon A, galyfilcon A, and asmofilcon A.

[0079] As stated, in preferred embodiments, the contact lenses of the present invention can be considered to be soft contact lenses, and in particular soft silicone hydrogel contact lenses.

[0080] Contact lenses can have any eyeglass wearing mode. Eyeglass wearing mode refers to how many days and nights the eyeglasses can be worn continuously without removal. In one example, the contact lenses are daily disposables. Daily disposables are indicated for single use, up to about 12 or 16 hours of continuous wear and should be discarded after a single use. In another example, the contact lenses are daily wear glasses. Daily wear glasses are worn during waking hours, usually up to about 12 to 16 hours, and removed before going to bed. Daily wear glasses are usually stored in a contact lens case containing a contact lens care solution for cleaning and disinfecting the glasses during non-use time. Daily wear glasses are usually discarded after up to 30 days of wear. In another example, the contact lenses are long-term wear glasses. Long-term wear glasses are usually worn continuously for up to 6, 14 or 30 consecutive days and nights.

[0081] As part of the present invention, the concave contact lens can be sealed in the contact lens package. The packaging solution sealed in the contact lens package can be any conventional contact lens compatible solution. In one example, the packaging solution includes an aqueous solution of a buffer and / or a tonicity agent, which is composed of an aqueous solution of a buffer and / or a tonicity agent or is substantially composed of an aqueous solution of a buffer and / or a tonicity agent. In another example, the packaging solution contains additional agents, such as one or more additional antimicrobial agents and / or comfort agents and / or hydrophilic polymers and / or surfactants and / or other beneficial agents. In some examples, the packaging solution may include polysaccharides (e.g., hyaluronic acid, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, etc.) or other high molecular weight polymers (e.g., polyvinyl pyrrolidone) commonly used as comfort polymers or thickeners in ophthalmic solutions and contact lens packaging solutions. In other examples, the packaging solution may include ophthalmic drugs. The packaging solution may have a pH in the range of about 6.8 or 7.0 to as high as about 7.8 or 8.0. In one example, the packaging solution includes a phosphate buffer or a borate buffer. In another example, the packaging solution includes a tonicity agent selected from sodium chloride or sorbitol in an amount to maintain osmotic pressure in the range of about 200 to 400 mOsm / kg and typically from about 270 mOsm / kg up to about 310 mOsm / kg.

[0082] For contact lens packaging, such packaging may include or comprise a plastic base member comprising a cavity configured to hold a contact lens and a packaging solution and a flange region extending outwardly around the cavity. A removable foil is attached to the flange region to provide a sealed contact lens package. Such contact lens packaging, commonly referred to as a "blister pack", is well known in the art (e.g., see U.S. Pat. No. 7,426,993).

[0083] It should be understood that conventional manufacturing methods can be used to manufacture sealed contact lens packaging. In a method for manufacturing contact lens packaging, the method may include placing unworn contact lenses and contact lens packaging solutions in a container, placing a cover on the container, and sealing the cover on the container. In general, the container is configured to receive a single contact lens and a quantitative (usually about 0.5 to 1.5 ml) packaging solution sufficient to completely cover the contact lens. The container can be made of any suitable material (such as glass or plastic). In one example, the container includes a plastic base member, the plastic base member includes a cavity configured to hold contact lenses and packaging solutions and a flange area extending outward around the cavity, and the cover includes a removable foil attached to the flange area to provide a sealed contact lens package. The removable foil can be sealed by any conventional means (such as heat sealing or gluing). In another example, the container is in the form of a plastic base member including a plurality of threads, and the cover includes a plastic cap member, the plastic cap member includes a threaded engagement for use with the base member, thereby providing a group of compatible threads of a resealable cover. It should be understood that other types of packaging may also be used to provide a resealable package. For example, the contact lens package may include a plastic cover that includes features that engage with compatible features of the container to form an interference fit. The method of manufacturing a sealed contact lens package may further include sterilizing unworn contact lenses by treating the sealed contact lens package with high temperature and high pressure steam. The high temperature and high pressure steam treatment typically involves subjecting the sealed contact lens package to a temperature of at least 121° C. for at least 20 minutes.

[0084] The concave contact lens can be provided unworn (i.e., a new contact lens not previously used by a patient), immersed in a packaging solution and sealed in a package. The package can be a blister package, a glass vial, or other suitable container. The package includes a base member having a cavity for containing the packaging solution and the unworn contact lens. The sealed package can be sterilized by a sterilizing amount of radiation (including heat or steam, such as by high temperature and high pressure steam treatment or by gamma radiation, electron beam radiation, ultraviolet radiation, etc.).

[0085] In a specific example, the packaged receptacle contact lenses are sterilized by high temperature and high pressure steam treatment.

[0086] The final product can be a sterile packaged concave contact lens (eg, a silicone hydrogel concave contact lens) having an ophthalmically acceptable surface wettability.

[0087] The concave contact lens of the concave can transfer an additional volume of solution from the blister package or other added fluids such as from a bottle or eye dropper. For example, as compared to a control lens, at least an additional amount of at least 0.025 μl of packaging solution or other fluid can be transferred from the blister package or from another source (such as eye drops) to the back surface to the ocular surface. Therefore, the concave contact lens can be used in a method of delivering a beneficial agent to the ocular surface of a subject. In one example, the method includes removing the concave contact lens from the blister package packaging solution and placing the concave contact lens on the cornea of ​​the subject, wherein the packaging solution includes a beneficial agent. In another example, the method includes applying an ophthalmic solution to the back surface of the concave contact lens and placing the concave contact lens on the cornea of ​​the subject, wherein the ophthalmic solution includes a beneficial agent.

[0088] In making the contact lenses of the present invention, a mold insert (also referred to as a master mold or mold tool) is formed, which is then used to form a mold part. The mold insert is made in a conventional manner, except that the desired dimple parameters and pattern are first formed on the surface of the mold insert. As discussed above, in a preferred embodiment, the rear surface is the surface having the dimple pattern and thus the mold insert used to form the male mold part can be formed to have the desired dimple parameters and pattern. The dimple parameters and pattern can be formed on the mold insert using any technology, such as laser micromachining and / or nanoimprint lithography and preferably by laser ablation. The mold insert is used to form the mold part by casting or injection molding. Generally speaking, thermoplastic materials such as (but not limited to) polypropylene, ethylene-vinyl alcohol, polyethylene terephthalate and the like are used to form the mold part. As can be appreciated, the surface of the mold part used to provide the dimple pattern for the contact lens has a negative pattern of the dimple pattern present on the mold insert. If the front side of the lens does not have dimples, then a conventional female mold insert can be used to form the female mold part. The polymerizable composition is dispensed into a female mold part having a concave surface defining the front surface of the concave contact lens. Thus, according to a preferred method, a male mold part having a convex surface defining the rear surface of the concave contact lens is combined with a female mold part to form a contact lens mold that is subjected to curing conditions (e.g., UV or thermal curing conditions, under which the curable composition is formed into a polymer lens body). The female and male mold parts may be non-polar molds or polar molds. The mold is disassembled (i.e., demolded) and the polymer lens body is removed from the mold and contacted with an organic solvent (e.g., ethanol) to extract unreacted components from the lens body. After extraction, the lens body is hydrated in an aqueous solution. An exemplary method for making a silicone hydrogel contact lens is described in U.S. Pat. No. 8,865,789.

[0089] Figures 11A to 11CA partially exploded cross-sectional view (not to scale) of an injection molded insert (30) and a male mold member (40) of a molding assembly for making a concave contact lens (10) is illustrated. The injection molded insert (30) is first used to create the male mold member (40). The injection molded insert (30) may be considered a master mold or mold tool. The injection molded insert (30) includes a dimple pattern (32) of dimples (34). The dimple pattern (32) of the injection molded insert (30) is the same dimple pattern (24) cast on the contact lens (without taking into account shrinkage of the male mold member and / or shrinkage or swelling of the contact lens material). The dimple pattern (32) of the injection molded insert (30) is designed with consideration of swelling of a dry lens to a hydrated wet contact lens. As mentioned above, the dimple pattern (32) may be laser machined into the injection molded insert (30). Laser ablation provides smooth edges / sides compared to dimples machined into the injection molded insert (30). The injection molded insert (30) is used to injection mold thermoplastic polymers (such as polypropylene) and the resulting contact lens mold (male mold part (40)) has domes (44) on its surface.

[0090] As mentioned above, in a preferred embodiment, the convex surface of the male mold part (40) of the mold has a dome pattern (42) including domes (44). The dome pattern (42) is the negative of the desired dimple pattern (24) on the dry concave contact lens (10). The dome pattern (42) thereby forms a dimple pattern on the contact lens molded therein, the dimples (20) including the same dimensions and characteristics described above for the dry concave contact lens (10).

[0091] As an alternative to using an injection molded insert to create the male mold part, the dome can be placed (eg, embossed) directly onto the plastic mold, which creates a dimple on the concave contact lens.

[0092] The following examples illustrate certain aspects and advantages of the present invention, which should be understood not to be limiting thereof.

[0093] Example 1

[0094] Parabolic shaped dimples are formed on the metal insert of the male contact lens mold part by laser ablation. The metal insert is used to injection mold a polypropylene male contact lens mold part having domes on the molding surface. The silicone hydrogel contact lens is prepared by dispensing a polymerizable silicone hydrogel composition for stenfilcon A into a female mold. A male mold part having a dome pattern having a negative pattern of the dimple pattern on the corresponding metal insert of the male mold part is combined with a female mold part to form a contact lens mold and subjected to curing conditions. The mold is disassembled (i.e., demolded) and the cured polymer lens body is removed from the mold. The dimples on the rear surface of the polymer lens body have the same size as the dimples on the corresponding metal insert (not accounting for shrinkage).

[0095] The polymer lens body is contacted with an organic solvent to extract unreacted components from the lens body. The lens body is then hydrated in an aqueous solution. Since the stenfilcon A material has a 22% expansion factor (which means that the size of a fully hydrated contact lens is 22% larger than the size of the polymer lens body before extraction and hydration (i.e., a dry lens)), the size of each dimple of the hydrated lens is 22% larger than the size of each dimple on the polymer lens body (and on the metal insert).

[0096] Example 2

[0097] Exemplary dimple sizes for a metal insert (and polymer lens body) and a hydrated lens made of stenfilcon A are shown in Table 1. The values ​​present in the last four rows (number of dimples (rounded to the nearest 1000), % dimple coverage, fill volume, and % volume increase) depend on the size of the contact lens and the size of the portion of the contact lens containing the dimples. In the case of Table 1, the values ​​for these parameters are based on a hydrated contact lens diameter of 14.2 mm, an 8 mm diameter optic zone with no dimples, a peripheral zone with dimples evenly distributed therein (except that the outermost areas of the peripheral zone within 0.1 mm from the circumferential edge of the hydrated contact lens are devoid of dimples). Thus, the width of the concave portion of the contact lens is 3.0 mm.

[0098] Table 1

[0099]

[0100] Table 2 shows the number of dimples, % dimple coverage, fill volume, and % volume increase, and the total number of dimples of the lens is the same as the lens described above for Table 1, except that the inner periphery of the concave portion of the lens is 5.5 mm from the center of the optic zone and the outer periphery of the concave portion is located 0.1 mm from the circumferential edge of the hydrated contact lens. Therefore, the width of the concave portion of the contact lens is 1.5 mm.

[0101] Table 2

[0102] A B C D E F G Number of pits (thousands) 175 310 11 44 78 19 44 % Dimple Coverage 10％ 18％ 2％ 10％ 18％ 10％ 2％ Filling volume (μl) 0.06 0.11 0.05 0.19 0.33 0.28 0.02 % Volume Increase 13％ 23％ 10％ 39％ 70％ 59％ 3％

[0103] The present invention comprises the following aspects / embodiments / features in any order and / or in any combination:

[0104] 1. The present invention relates to a contact lens comprising: a posterior surface having an optic zone, a peripheral zone and a circumferential edge, wherein the peripheral zone has dimples numbering at least 1000 dimples, wherein the dimples provide a filling volume of at least 0.01 μl and have a dimple coverage of up to 80% based on the total surface area of ​​the posterior surface.

[0105] 2. A contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have an average dimple diameter from about 5 microns to about 60 microns, an average dimple pitch from about 10 microns to about 150 microns, and the dimple coverage range is from 5% to 80%, and the dimples are arranged so that no overall discernible geometry results from the positions of the dimples, and the contact lens has a post-blink movement on the eye that is no greater than the post-blink movement of a control lens, the control lens being identical except that no dimples are present, and the contact lens has the same oxygen permeability as the control lens.

[0106] 3. A contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have an average dimple diameter from about 20 microns to about 40 microns, an average dimple pitch from about 30 microns to about 80 microns, and the dimple coverage is from 5% to 60%, and the dimples are arranged such that no overall discernible geometry results from the positions of the dimples, and the contact lens has the same post-blink movement on the eye as a control lens, the control lens being the same except that no dimples are present, and the contact lens has the same oxygen permeability as the control lens.

[0107] 4. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens has an anterior surface without dimples on the anterior surface.

[0108] 5. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples are not in contact with each other.

[0109] 6. The contact lens according to any preceding or following embodiment / feature / aspect, wherein each of the dimples has a dimple diameter that is within 20% of the average dimple diameter.

[0110] 7. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples are a combination of more than one type of dimples, each of the types having at least a different average dimple diameter.

[0111] 8. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples are arranged such that no spoke pattern, line pattern or ring pattern is present.

[0112] 9. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have an average dimple depth of at least 5 microns.

[0113] 10. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have an average dimple depth of at least 10 microns.

[0114] 11. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have an average dimple depth of at least 15 microns.

[0115] 12. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have an average dimple depth of from 15 microns to 40 microns.

[0116] 13. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have a combination of more than one dimple depth.

[0117] 14. The contact lens according to any preceding or following embodiment / feature / aspect, wherein each of the dimples has an average dimple depth to diameter ratio of at least 0.25.

[0118] 15. The contact lens according to any preceding or following embodiment / feature / aspect, wherein said number of dimples is from 5,000 to 1,000,000.

[0119] 16. The contact lens according to any preceding or following embodiment / feature / aspect, wherein said number of dimples is from 10,000 to 200,000.

[0120] 17. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples each have smooth edges around the dimple opening to avoid sharp corners.

[0121] 18. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples are randomly, quasi-randomly or uniformly dispersed in the peripheral zone.

[0122] 19. The contact lens according to any preceding or following embodiment / feature / aspect, wherein each of the dimples has an average intra-dimple pitch to diameter ratio of at least 1.25.

[0123] 20. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimples have more than one combination of dimple pitches.

[0124] 21. The contact lens according to any preceding or following embodiment / feature / aspect, wherein each of the dimples has a cross-sectional side view that is circular, elliptical, triangular, rectangular, Gaussian, or parabolic.

[0125] 22. The contact lens according to any preceding or following embodiment / feature / aspect, wherein each of the dimples has a top view that is circular, oval, triangular or rectangular.

[0126] 23. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens is a soft contact lens.

[0127] 24. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens is a silicone hydrogel contact lens.

[0128] 25. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the dimple is positioned at least 0.05 mm away from the circumferential edge.

[0129] 26. A contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens has a volume increase percentage of at least 50% as compared to a control lens, wherein the control lens is a lens without the presence of dimples in the lens but otherwise identical to the contact lens.

[0130] 27. A contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens has a volume increase percentage of at least 80% as compared to a control lens, wherein the control lens is a lens without the presence of dimples in the lens but otherwise identical to the contact lens.

[0131] 28. A contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens has a volume increase percentage from 5% to 200% as compared to a control lens, wherein the control lens is a lens without the presence of dimples in the lens but otherwise identical to the contact lens.

[0132] 29. The contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens has no dimples or has a quasi-random distribution of the dimples positioned within 5 mm of the center of the contact lens.

[0133] 30. A contact lens according to any preceding or following embodiment / feature / aspect, wherein the contact lens has a quasi-random distribution of the dimples positioned within 5 mm of the center of the contact lens and the dimples positioned at least 5.5 mm from the center of the contact lens have a uniform distribution of the dimples.

[0134] 31. The contact lens according to any preceding or following embodiment / feature / aspect, wherein all of the dimples on the contact lens are positioned at least 4.5 mm from the center of the contact lens.

[0135] 32. The present invention further relates to a mold for casting contact lenses, the mold having a dome pattern, the dome pattern being the negative pattern of a dimple pattern of dimples formed on a peripheral zone of a contact lens molded therein, the number of dimples being at least 1000 dimples, wherein the dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80%.

[0136] 33. The present invention further relates to an injection molded insert for forming a mold for a cast-molded contact lens, the injection molded insert having a dimple pattern of dimples formed on a peripheral zone of a cast-molded contact lens, the number of dimples being at least 1000 dimples, wherein the dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80%.

[0137] 34. The present invention further relates to a method for administering a beneficial agent to the ocular surface of a subject, comprising placing a concave contact lens as described in any one of technical solutions 1 to 25 on the cornea of ​​the subject, wherein before placing the concave contact lens on the cornea, (a) the concave contact lens is removed from a contact lens packaging solution including the beneficial agent, or (b) an ophthalmic solution including the beneficial agent is applied to the back surface of the concave contact lens.

[0138] The present invention may comprise any combination of these various features or embodiments above and / or below as set out in sentences and / or paragraphs.Any combination of features disclosed herein is considered part of the present invention and no limitation on combinable features is intended.

[0139] The disclosure herein refers to certain illustrated examples, but it should be understood that these examples are presented by way of example and not by way of limitation. The foregoing detailed description is intended to discuss exemplary examples, but should be interpreted as covering all modifications, alternatives, and equivalents of the examples as may fall within the spirit and scope of the invention as defined by the additional disclosure.

[0140] All cited references in this disclosure are hereby incorporated by reference in their entirety to the extent they are not inconsistent with this disclosure.

[0141] The present invention may include any combination of various features or embodiments described in the claims above and / or below as set forth in sentences and / or paragraphs. Any combination of features disclosed herein is considered part of the present invention and no limitation on combinable features is intended.

[0142] Other embodiments of the invention will be apparent to those skilled in the art in view of the specification and practice of the invention disclosed herein.It is intended that the specification and examples be considered exemplary only, with the true scope and spirit of the invention being indicated by the following claims and their equivalents.

Claims

1. A contact lens comprising: A posterior surface having an optic zone, a peripheral zone, and a circumferential edge, and the peripheral zone having dimples numbering at least 1000 dimples, wherein the dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80% based on the total surface area of ​​the posterior surface, wherein the dimples have an average dimple diameter from 5 microns to 60 microns, an average dimple pitch from 10 microns to 150 microns, and the dimple coverage is from 5% to 80%, and the dimples are arranged so that no overall discernible geometry results from the positions of the dimples, and the contact lens has a post-blink movement on the eye that is no greater than a post-blink movement of a control lens, the control lens being identical except that no dimples are present, and the contact lens having the same oxygen permeability as the control lens.

2. The contact lens of claim 1, wherein the dimples have an average dimple diameter from 20 microns to 40 microns, an average dimple pitch from 30 microns to 80 microns, and the dimple coverage is from 5% to 60%, and the contact lens has the same post-blink movement on the eye as the control lens.

3. The contact lens of claim 1 or 2, wherein the contact lens has an anterior surface without dimples on the anterior surface.

4. The contact lens of claim 1 or 2, wherein the dimples are not in contact with each other.

5. The contact lens of claim 1 or 2, wherein the dimples are a combination of more than one type of dimples, each of the types having at least a different average dimple diameter.

6. The contact lens of claim 1 or 2, wherein the dimples are configured such that no spoke pattern, line pattern, or ring pattern is present.

7. The contact lens of claim 1 or 2, wherein the dimples have an average dimple depth of at least 5 microns.

8. The contact lens of claim 1 or 2, wherein the dimples have an average dimple depth of at least 10 microns.

9. The contact lens of claim 1 or 2, wherein the dimples have an average dimple depth of at least 15 microns.

10. The contact lens of claim 1 or 2, wherein the dimples have an average dimple depth of from 15 microns to 40 microns.

11. The contact lens of claim 1 or 2, wherein the dimples have a combination of more than one dimple depth.

12. The contact lens of claims 1 or 2, wherein the dimples each have an average dimple depth to diameter ratio of at least 0.

25.

13. The contact lens of claim 1 or 2, wherein the number of dimples is from 5,000 to 1,000,000.

14. The contact lens of claim 1 or 2, wherein the number of dimples is from 10,000 to 200,000.

15. The contact lens of claim 1 or 2, wherein the dimples each have smooth edges around the dimple opening to avoid sharp corners.

16. The contact lens of claim 1 or 2, wherein the dimples are randomly, quasi-randomly, or uniformly dispersed in the peripheral zone.

17. The contact lens of claims 1 or 2, wherein the dimples each have an average dimple pitch to diameter ratio of at least 1.

25.

18. The contact lens of claim 1 or 2, wherein the dimples have more than one combination of dimple pitches.

19. The contact lens of claim 1 or 2, wherein the dimples each have a cross-sectional side view that is circular, elliptical, triangular, rectangular, Gaussian, or parabolic.

20. The contact lens of claim 1 or 2, wherein the dimples each have a top view that is circular, oval, triangular, or rectangular.

21. The contact lens of claim 1 or 2, wherein the contact lens is a soft contact lens.

22. The contact lens of claim 1 or 2, wherein the contact lens is a silicone hydrogel contact lens.

23. The contact lens of claim 1 or 2, wherein the dimples are located at least 0.05 mm away from the circumferential edge.

24. The contact lens of claim 1 or 2, wherein the contact lens has a quasi-random distribution of the dimples positioned within 5 mm of the center of the contact lens.

25. A contact lens according to claim 1 or 2, wherein the contact lens has a quasi-random distribution of the dimples positioned within 5 mm of the center of the contact lens and the dimples positioned at least 5.5 mm from the center of the contact lens have a uniform distribution of the dimples.

26. The contact lens of claim 1 or 2, wherein all of the dimples on the contact lens are located at least 4.5 mm from the center of the contact lens.

27. A mold for cast molding of a contact lens, the mold having a dome pattern, the dome pattern being the negative of a dimple pattern of dimples formed on a peripheral zone of a contact lens molded therein, the number of dimples being at least 1000 dimples, wherein the dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80%, wherein the dimples have an average dimple diameter from 5 microns to 60 microns, an average dimple pitch from 10 microns to 150 microns, and the dimple coverage is from 5% to 80%, and the dimples are arranged so that no overall discernible geometry results from the positions of the dimples, and the contact lens has a post-blink movement on the eye that is no greater than that of a control lens, the control lens being identical except that no dimples are present, and the contact lens having the same oxygen permeability as the control lens.

28. An injection molded insert for forming a mold for a cast mold of a contact lens, the injection molded insert having a dimple pattern of dimples formed on a peripheral zone of a cast molded contact lens, the number of dimples being at least 1000 dimples, wherein the dimples provide a fill volume of at least 0.01 μl and have a dimple coverage of up to 80%, wherein the dimples have an average dimple diameter from 5 microns to 60 microns, an average dimple pitch from 10 microns to 150 microns, and the dimple coverage is from 5% to 80%, and the dimples are arranged so that no overall discernible geometry results from the location of the dimples, and the contact lens has a post-blink movement on the eye that is no greater than the post-blink movement of a control lens, the control lens being identical except that no dimples are present, and the contact lens has the same oxygen permeability as the control lens.

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