Cosmetic contact lens having an elliptical dot pattern suitable for forming an apparent limbal ring

Abstract

Cosmetic contact lenses having features designed to enhance the appearance of the eye and optionally correct vision are described. In particular, the cosmetic contact lens has an elliptical dot pattern designed to cover the iris and thereby form an apparent limbal ring. These cosmetic contact lenses provide the eye with a more textured appearance with an apparent limbus ring for a contact lens wearer having a uniformly colored iris, such as a dark brown iris.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480072488.0 (22) Application Date 2024.11.13 (30) Priority Data 63 / 599594 2023.11.16 US 18 / 918530 2024.10.17 US (85) PCT International Application Entering National Phase Date 2026.05.14 (86) PCT International Application Application Data PCT / IB2024 / 061278 2024.11.13 (87) PCT International Application Publication Data WO2025 / 104612 EN 2025.05.22 (71) Applicant: Johnson & Johnson Vision Care, Inc. Address: Florida, USA (72) Inventors: E. Jolly, A.N. Seifer, A.P. Bergen (74) Patent Agency: China Patent Agent (Hong Kong) Limited, 72001 Patent Attorneys: Zheng Hao, Liu Chunyuan (51) Int.Cl. G02C 7 / 04 (2006.01) (54) Title of Invention: Cosmetic Contact Lens with an Elliptical Dot Pattern Suitable for Forming an Apparent Limb Ring (57) Abstract: Describes a cosmetic contact lens with features designed to enhance the appearance of the eye and optionally correct vision. Specifically, the cosmetic contact lens has an elliptical dot pattern designed to cover the iris and thereby form an apparent limbal ring. For contact lens wearers with uniformly colored irises such as dark brown irises, these cosmetic contact lenses provide the eye with a more textured appearance with an apparent limbal ring. Claims (2 pages), Description (18 pages), Drawings (5 pages), CN 122206972 A 2026.06.12 CN 1 22 20 69 72 A 1. A cosmetic contact lens comprising an elliptical dot pattern, wherein the elliptical dot pattern has a diameter equal to or greater than 8 mm and has a negative space between 70% and 100% in the outermost ring, the outermost ring having a thickness between 0.2 mm and 2.0 mm. 2. The cosmetic contact lens according to claim 1, wherein the outermost ring has a thickness between 0.5 mm and 1.5 mm. 3. The cosmetic contact lens according to any one of claims 1 to 2, wherein the diameter of the elliptical dot pattern is between 9 mm and 14 mm. 4. The cosmetic contact lens according to claim 3, wherein the diameter of the elliptical dot pattern is between 11 mm and 13 mm. 5. The cosmetic contact lens according to any one of claims 1 to 4, wherein the negative space in the outermost ring is between 80% and 100%. 6. A cosmetic contact lens, said cosmetic contact lens comprising an elliptical dot pattern,The elliptical dot pattern includes a negative space, wherein when the elliptical dot pattern covers the iris, the negative space creates an apparent limbal ring. 7. The cosmetic contact lens of claim 6, wherein the negative space is between 70% and 100%. 8. The cosmetic contact lens of claim 7, wherein the negative space is between 80% and 100%. 9. The cosmetic contact lens of any one of claims 6 to 8, wherein the negative space increases radially from the center of the lens. 10. The cosmetic contact lens of any one of claims 6 to 9, wherein the apparent limbal ring has a thickness between 0.2 mm and 2.0 mm. 11. The cosmetic contact lens of claim 10, wherein the thickness of the apparent limbal ring is between 0.5 mm and 1.5 mm. 12. The cosmetic contact lens of any one of claims 6 to 11, wherein the diameter of the elliptical dot pattern is equal to the average iris diameter of the human population. 13. The cosmetic contact lens of any one of claims 6 to 12, wherein the diameter of the elliptical dot pattern is equal to or greater than 8 mm. 14. The cosmetic contact lens of claim 13, wherein the diameter of the elliptical dot pattern is between 9 mm and 14 mm. 15. The cosmetic contact lens of claim 14, wherein the diameter of the elliptical dot pattern is between 11 mm and 13 mm. 16. The cosmetic contact lens of any one of claims 6 to 15, wherein the elliptical dot pattern and the iris exhibit a color difference (ΔE) between 23 and 79. 17. The cosmetic contact lens of claim 16, wherein the color difference (ΔE) between the elliptical dot pattern and the iris is between 23 and 54. 18. The cosmetic contact lens of claim 17, wherein the color difference (ΔE) between the elliptical dot pattern and the iris is between 34 and 54. 19. The cosmetic contact lens of any one of claims 1 to 18, wherein the elliptical dot pattern comprises elliptical dots having a major axis between 10 micrometers and 200 micrometers. 20. The cosmetic contact lens of claim 19, wherein the elliptical dot pattern comprises elliptical dots having a major axis between 25 micrometers and 150 micrometers. Claims 1 / 2 page 2 CN 122206972 A 21. The cosmetic contact lens of claim 20, wherein the elliptical dot pattern comprises elliptical dots having a major axis between 30 micrometers and 120 micrometers. 22. The cosmetic contact lens of any one of claims 1 to 21, wherein the elliptical dots are circles. 23. The cosmetic contact lens of any one of claims 1 to 22, wherein...The elliptical dot pattern further includes dots of non-elliptical shape. 24. The cosmetic contact lens according to any one of claims 1 to 23, wherein the elliptical dot pattern is formed by pad printing using an ink containing a colorant. 25. The cosmetic contact lens according to claim 24, wherein the colorant is selected from the group consisting of iron oxide, titanium dioxide, mica pigment, phthalocyanine, carbazole violet, and combinations thereof. 26. The cosmetic contact lens according to any one of claims 24 to 25, wherein the elliptical dot pattern is formed by pad printing using one or more printing layers, each of the one or more printing layers being individually composed of the elliptical dot pattern. 27. The cosmetic contact lens according to claim 26, wherein the printing layers overlap and produce other geometries. 28. The cosmetic contact lens according to any one of claims 1 to 27, wherein the elliptical dot pattern varies radially and circumferentially. 29. The cosmetic contact lens according to any one of claims 1 to 28, wherein the cosmetic contact lens is made of hydrogel. 30. The cosmetic contact lens according to any one of claims 1 to 28, wherein the cosmetic contact lens is made of silicone hydrogel. 31. The cosmetic contact lens according to any one of claims 1 to 30, wherein the cosmetic contact lens is coated. 32. The cosmetic contact lens according to any one of claims 1 to 31, further comprising an optical zone at the center of the lens, wherein the optical zone does not contain an elliptical dot pattern. 33. The cosmetic contact lens according to claim 32, wherein the optical zone is designed to correct myopia, hyperopia, astigmatism, or presbyopia. Claims 2 / 2 Page 3 CN 122206972 A Cosmetic contact lens having an elliptical dot pattern suitable for forming an apparent limbal ring

[0001] Related Applications This application claims priority to U.S. Patent Application Serial No. 18 / 918,530, filed October 17, 2024, and U.S. Provisional Patent Application Serial No. 63 / 599,594, filed November 16, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention relates to cosmetic contact lenses having features designed to enhance the appearance of the eyes of a contact lens wearer and optionally correct refractive errors. Background Art

[0003] It is known to use colored and patterned contact lenses to alter the natural color and appearance of the eyes for cosmetic purposes. Such cosmetic contact lenses are designed to alter the color and texture of the iris of the eye. Each person has a unique iris pattern. Each person's unique iris pattern depends on the underlying matrix of collagen fibers and the local concentration of melanin, resulting in a variety of concentric or radial bands that may be dark or light.Many different geometric shapes of dark spots and fibrous network structures. Another common feature of the human iris is the limbal ring. The limbal ring is a dark ring around the periphery of the iris, creating a distinct boundary between the iris and sclera of the eye, thus providing greater contrast and making the iris appear more colorful.

[0004] However, some people lack a prominent limbal ring in their iris, possibly due to the uniformity and position of color and pattern, for example, individuals with dark brown eyes. Therefore, there is a need for a patterned cosmetic contact lens that creates the appearance of a limbal ring for people without an easily identifiable limbal ring, thus creating a more attractive appearance. Summary of the Invention

[0005] The present invention relates to a cosmetic contact lens with an elliptical dot pattern that, when worn on the eye, creates an apparent limbal ring in the peripheral negative space of the cosmetic contact lens. The apparent limbal ring is formed by a combination of the elliptical dot pattern, the color of the underlying iris in the negative space of the elliptical dot pattern, and the color difference between the elliptical dot pattern and the underlying iris.

[0006] In one exemplary aspect, the present invention provides a cosmetic contact lens comprising an elliptical dot pattern, wherein the elliptical pattern has a diameter equal to or greater than 8 mm and has a negative space of between 70% and 100% in an outermost ring having a thickness between 0.2 mm and 2.0 mm.

[0007] In another exemplary aspect, the present invention provides a cosmetic contact lens comprising an elliptical dot pattern including a negative space, wherein the negative space creates an apparent limbal ring when the elliptical dot pattern covers the iris of the eye. The negative space creating the apparent limbal ring can be between 70% and 100%. The thickness of the apparent limbal ring can be between 0.2 mm and 2.0 mm. The diameter of the elliptical dot pattern can be equal to or greater than 8 mm. The diameter of the elliptical dot pattern can correspond to the average iris diameter of the human population, for example, between 9 mm and 14 mm.

[0008] In another aspect, the present invention provides a cosmetic contact lens, the cosmetic contact lens further comprising an optical zone at the center of the lens, wherein the optical zone does not contain an elliptical dot pattern. The optical zone can be used to correct refractive errors such as myopia, hyperopia, astigmatism, and presbyopia.

[0009] In another aspect, the present invention provides a method for designing an elliptical dot pattern, the method comprising the steps of: (a) selecting a diameter of the elliptical dot pattern, the diameter corresponding to the average iris diameter of a human population; (b) selecting a thickness of the outermost ring of the elliptical dot pattern between 0.2 mm and 2.0 mm; and (c) generating an elliptical dot pattern having a negative space between 70% and 100% in the outermost ring, wherein the elliptical dot pattern surrounds the optical zone.

[0010] According to another aspect,This invention provides a method for preparing cosmetic contact lenses having an elliptical dot pattern suitable for forming an apparent limbal ring, the method comprising the steps of: (a) optionally, transferring a clear layer onto a front-curved mold of a contact lens mold assembly; (b) transferring one or more printed layers on top of the clear layer (if present), or otherwise onto the front-curved mold of the contact lens mold assembly, wherein these printed layers form an elliptical dot pattern suitable for forming an apparent limbal ring; (c) dispensing a reactive monomer mixture into the front-curved mold; (d) positioning a base-curved mold on top of the front-curved mold to form a contact lens mold assembly having a cavity in the shape of a contact lens; (e) polymerizing the reactive monomer mixture; (f) removing the cosmetic contact lens from the mold assembly; (g) extracting the cosmetic contact lens; and (h) hydrating the cosmetic contact lens. The cosmetic contact lens can then be packaged and sterilized.

[0011] The printed layers are formed using inks containing various colorants, such as iron oxide, titanium dioxide, mica pigment, phthalocyanine, carbazole violet, and combinations thereof. One property of these printed layers is that they can form an elliptical dot pattern that exhibits a color difference (ΔE) between 23 and 79 compared to the color of the contact lens wearer's iris.

[0012] Figure 1 shows a schematic diagram of the elliptical dot pattern and its outermost ring.

[0013] Figure 2 shows a front view of an exemplary cosmetic contact lens.

[0014] Figure 3 shows a left-side view of an exemplary cosmetic contact lens.

[0015] Figure 4 shows a right-side view of an exemplary cosmetic contact lens.

[0016] Figure 5 shows four exemplary printed layers A-D that can be used to create the elliptical dot pattern.

[0017] Figure 6 shows an image of (A) a representative elliptical dot pattern, (B) a dark brown eye model, and (C) an image of a cosmetic contact lens having the same pattern shown in (A) after being placed on the dark brown eye model shown in (B), showing the apparent limbal ring around the pattern. Detailed Description

[0018] It should be understood that the invention is not limited to the details of the construction or process steps set forth in the following description. Using the teachings herein, the invention can have other embodiments and can be practiced or implemented in various ways.

[0019] Definitions Regarding the terms used in this disclosure, the following definitions are provided. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Polymer definitions conform to the definitions disclosed in the Compendium of Polymer Terminology and Nomenclature, IUPAC Recommendations 2008.This compilation was edited by Richard G. Jones, Jaroslav Kahovec, Robert Stepto, Edward S. Wilks, Michael Hess, Tatsuki Kitayama, and W. Val Metanomski. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference. Specification 2 / 18 pages 5 CN 122206972 A

[0020] As used herein, the term “polymerizable” means a compound containing at least one polymerizable group. A “polymerizable group” is a group capable of undergoing chain-growth polymerization such as free radical polymerization. Non-limiting examples of polymerizable groups (Pg) include (meth)acrylates, styrene, vinyl ethers, (meth)acrylamide, N-vinyl lactam, N-vinylamide, O-vinylcarbamate, O-vinyl carbonate, and other vinyl groups. The term “(meth)” refers to optional methyl substitution. Thus, terms such as “(meth)acrylate” refer to both methacrylates and acrylates. The polymerizable group may be unsubstituted or substituted. For example, the nitrogen atom in (meth)acrylamide may be bonded to hydrogen, or the hydrogen may be replaced by an alkyl or cycloalkyl group (which itself may be further substituted). The term "non-polymerizable" means, in contrast to "polymerizable," that the compound does not contain such polymerizable groups.

[0021] A "polymer" is a target macromolecule composed of repeating units of monomers and macromonomers used during polymerization. The phrase "number-average molecular weight" refers to the number-average molecular weight (Mn) of a polymer sample; the phrase "weight-average molecular weight" refers to the weight-average molecular weight (Mw) of a polymer sample; the phrase "polydispersity index" (PDI) refers to the ratio of Mw to Mn and describes the molecular weight distribution of the polymer sample. If the type of "molecular weight" is not indicated or is not obvious from the context, it is intended to represent the number-average molecular weight. The average number of repeating units in a polymer sample is called its "degree of polymerization." When a general chemical formula for a polymer sample is used, such as [***]n, "n" refers to its degree of polymerization, and the formula should be understood to represent the number-average molecular weight of the polymer sample.

[0022] A “repeating unit” is the smallest group of atoms in a polymer, corresponding to the polymerization of a specific monomer or macromonomer.

[0023] A “homopolymer” is a polymer made from one monomer; a “copolymer” is a polymer made from two or more monomers; a “terpolymer” is a polymer made from three monomers. A “block copolymer” is composed of blocks or segments that are compositionally different. A diblock copolymer has two blocks. A triblock copolymer has three blocks. A “comb or graft copolymer” is made from at least one macromonomer.

[0024] As used herein, a “monomer” is a monofunctional molecule that can undergo chain-growth polymerization.Such as free radical polymerization, thereby generating repeating units in the chemical structure of the target macromolecule. Some monomers have difunctional impurities that can act as crosslinking agents. "Hydrophilic monomer" is a monomer that produces a clear single-phase solution when mixed with deionized water at a concentration of 5% by weight at 25°C. "Hydrophilic component" is a monomer, macromonomer, prepolymer, initiator, crosslinking agent, additive, or polymer that produces a clear single-phase solution when mixed with deionized water at a concentration of 5% by weight at 25°C. "Hydrophobic component" is a monomer, macromonomer, prepolymer, initiator, crosslinking agent, additive, or polymer that is slightly soluble or insoluble in deionized water at 25°C.

[0025] "Macromonomer" is a macromolecule having a group that can undergo chain growth polymerization, such as free radical polymerization, thereby generating repeating units in the chemical structure of the target macromolecule. Typically, the chemical structure of the macromonomer differs from the chemical structure of the target macromolecule; in other words, the repeating units of the side groups of the macromonomer differ from the repeating units of the target macromolecule or its main chain. The difference between a monomer and a macromonomer is only one of chemical structure, molecular weight, and molecular weight distribution of side groups. A macromonomer can be hydrophilic, for example when the macromolecule is a polyether such as poly(ethylene glycol), or hydrophobic, for example when the macromolecule is a poly(dialkylsiloxane).

[0026] A “crosslinking agent” or “crosslinking agent” is a difunctional or polyfunctional monomer capable of undergoing free radical polymerization at two or more sites on the molecule to form branch points and a polymer network. The two or more polymerizable functional groups on the crosslinking agent can be the same or different, and can be selected, for example, independently from vinyl groups (including allyl), (meth)acrylate groups, and (meth)acrylamide groups. Common examples are ethylene glycol dimethacrylate, tetraethylene glycol dimethacrylate, trimethylolpropane trimethacrylate, methylenebisacrylamide, triallyl cyanurate, etc.

[0027] A “prepolymer” is the reaction product of a monomer (or macromonomer) containing polymerizable groups capable of undergoing further reactions to form a polymer. Instruction manual 3 / 18 pages 6 CN 122206972 A

[0028] "Polymer network" is a type of polymer in the form of cross-linked macromolecules. Generally speaking, polymer networks can swell but cannot dissolve in solvents.

[0029] "Hydrogel" is a polymer network that swells in water or an aqueous solution, typically absorbing at least 10% by weight of water at 25°C. "Organosilicon hydrogel" is a hydrogel made from at least one component containing organosilicon and at least one hydrophilic component. The hydrophilic component may also include a non-reactive polymer.Such as polyamides.

[0030] "Conventional hydrogels" refer to polymeric networks made of monomers that do not contain any organosilicon-containing components. Conventional hydrogels are prepared from reactive compositions that primarily contain hydrophilic monomers such as 2-hydroxyethyl methacrylate ("HEMA"), N-vinylpyrrolidone ("NVP"), N,N-dimethylacrylamide ("DMA"), N-vinylmethylacetamide (VMA) or vinyl acetate.

[0031] As used herein, "organosilicon-containing components" or "organosilicon components" are monomers, macromonomers, prepolymers, crosslinking agents, initiators, additives or polymers in reactive compositions that have at least one siloxane bond.Typically in the form of silanoxy groups, siloxane groups, carbosiloxane groups, and mixtures thereof. Examples of organosilicon-containing components that can be used in this invention can be found in U.S. Patents 3,808,178, 4,120,570, 4,136,250, 4,153,641, 4,740,533, 5,034,461, 5,070,215, 5,244,981, 5,314,960, 5,331,067, 5,371,147, 5,760,100, 5,849,811, 5,962,548, and 5, No. 965,631, No. 5,998,498, No. 6,367,929, No. 6,822,016, No. 6,943,203, No. 6,951,894, No. 7,052,131, No. 7,247,692, No. 7,396,890, No. 7,461,937, No. 7,468,398, No. 7,538,146, No. 7,553,880, No. 7,572,841, No. 7,666,921, No. 7,691,916, No. 7,786,185 Numbers: 7,825,170, 7,915,323, 7,994,356, 8,022,158, 8,163,206, 8,273,802, 8,399,538, 8,415,404, 8,420,711, 8,450,387, 8,487,058, 8,568,626, 8,937,110, 8,937,111, 8,940,812, 8,980,972, 9, The patents referred to herein are patents 056,878, 9,125,808, 9,140,825, 9,156,934, 9,170,349, 9,217,813, 9,244,196, 9,244,197, 9,260,544, 9,297,928, and 9,297,929. The entire contents of these patents are incorporated herein by reference. Representative examples of components containing organosilicon are mono-n-butyl-terminated monomethacryloyloxypropyl-terminated polydimethylsiloxane (mPDMS), mono-n-butyl-terminated mono-(2-hydroxy-3-methacryloyloxypropoxy)-propyl-terminated polydimethylsiloxane (OH-mPDMS), and 3-(3-(1,1,1,3,5,5,5-heptamethyltrisiloxane-3-yl)propoxy)-2-hydroxypropyl methacrylate (SiMAA).

[0032] An "initiator" is a molecule that can decompose into free radical groups.These free radical groups can react with monomers to initiate free radical polymerization. Thermal initiators decompose at a certain rate depending on the temperature; typical examples are azo compounds, such as 1,1'-azobisisobutyronitrile and 4,4'-azobis(4-cyanopentanoic acid), peroxides, such as benzoyl peroxide, tert-butyl peroxide, tert-butyl hydroperoxide, tert-butyl peroxybenzoate, dicumyl peroxide and lauroyl peroxide, peracids, such as peracetic acid and potassium persulfate, and various redox systems. Photoinitiators decompose by photochemical methods; typical examples are benzoyl, benzoin, acetophenone, benzophenone, camphorquinone and mixtures thereof, and various monoacyl and diacylphosphine oxides and their combinations.

[0033] The terms "reactive mixture" and "reactive monomer mixture" refer to a mixture of components (both retained and non-retained) that form a polymer network (e.g., in the form of a contact lens) when subjected to polymerization conditions. The reactive mixture may contain: retaining components, such as monomers, macromonomers, prepolymers, crosslinking agents, and initiators; additives, such as wetting agents; polymers, such as polyamides; dyes, pigments, or colorants, such as "visible colorants," which make the contact lenses identifiable in the packaging; light-absorbing compounds, such as ultraviolet, high-energy visible light, and / or photochromic absorbers, which protect the eyes from harmful radiation and / or alter vision statically or dynamically based on lighting conditions; pharmaceutical compounds; and / or nutritional compounds, any of which may be reactive or non-reactive but are capable of being retained in the resulting polymer network. The reactive mixture may also contain non-retaining components intended to be removed from the polymer network prior to any use, such as diluents. Diluents are solvents and solvent mixtures used to dissolve and dilute the reactive monomer mixture. Depending on the composition of the reactive mixture, the diluent may be water-based or organic solvent-based. The diluent may be any organic solvent or mixture thereof, including aqueous solutions. The concentration of the components in the reactive mixture is expressed as a percentage by weight of all retained components in the reactive mixture (and therefore excluding non-retained components such as diluents). When diluents are used, their concentrations are expressed as a percentage by weight based on the amount of all components in the reactive mixture, including the diluent.

[0034] A “reactive component” is a component in the reactive monomer mixture that forms part of the polymer network structure of the resulting composition. A “retained component” is a polymerizable compound (such as monomers, macromonomers, oligomers, prepolymers, and crosslinking agents) in the reactive mixture, as well as any other component in the reactive mixture.These components are intended to remain substantially in the polymer network after polymerization and all post-processing steps (such as extraction steps) and packaging steps have been completed. Retained components may be retained in the polymer network by covalent bonding, hydrogen bonding, electrostatic interactions, the formation of interpenetrating polymer networks, or any other means. Components intended to be released from the polymer network when it is used are still considered “retained components.” For example, pharmaceutical or nutrient components in the polymer network intended to be released during use are considered “retained components.” Components intended to be removed from the polymer network during the manufacturing process (e.g., by extraction), such as diluents, are “non-retained components.”

[0035] “Polyamide” can include acyclic polyamides and cyclic polyamides, including homopolymers and copolymers. Typical examples of polyamides are polyvinylpyrrolidone (PVP), polyvinylmethyl acetamide (PVMA), polydimethylacrylamide (PDMA), polyvinylacetamide (PNVA), poly(hydroxyethyl(methyl)acrylamide), polyacrylamide, and mixtures thereof. Polyamides are commonly used as internal wetting agents and are disclosed in patents US6367929, US6822016, 7,052,131, US7666921, US7691916, US7786185, US8022158, and US8450387.

[0036] Unless otherwise specified, numerical ranges, such as in “2 to 10” or in “between 2 and 10”, include numbers that define the range (e.g., 2 and 10).

[0037] Unless otherwise specified, ratios, percentages, parts, etc., are by weight.

[0038] As used herein, the term “about” means that a number is modified within a range of + / - 10%. For example, the phrase “about 10” would include both 9 and 11.

[0039] As used herein, the term “contact lens” refers to an ophthalmic device that can be placed on the cornea of ​​the human eye. Contact lenses can provide beneficial effects on vision, aesthetics, and / or treatment. Contact lenses can be made from any suitable material known in the art. To make contact lenses more comfortable, techniques for fabricating contact lenses from hydrogels have been developed. Hydrogels are polymeric networks containing water. The properties of hydrogels can be controlled and modified through their chemical composition, crosslinking density, water content, and morphology. Therefore, hydrogels with a balance of physical and mechanical properties suitable for fabricating soft contact lenses have been developed. Firstly, contact lenses made from hydrogels that do not contain any silicone-containing components exist. Examples of such conventional hydrogels are etafilcon, omafilcon, nelfilcon, and nesofilcon, all of which have a water content exceeding 50% by weight. Conventional hydrogels are typically isotropic materials. One drawback of conventional hydrogels is their relatively low oxygen permeability, which can consequently affect the overall health of the cornea. To address this issue, contact lenses made from silicone hydrogels exist.It exhibits a balance of higher oxygen permeability than conventional hydrogels and physical and mechanical properties suitable for the fabrication of soft contact lenses. Silicone hydrogels are hydrogels made from at least one silicone-containing component and at least one hydrophilic component. The silicone-containing component contains at least one siloxane bond, typically in the form of a silanoxy group, a siloxane group, a carbosiloxane group, or mixtures thereof. Examples of such silicone hydrogels are lotrafilcon, balafilcon, galyfilcon, senofilcon, narafilcon, comfilcon, somofilcon, delefilcon, samfilcon, stenfilcon, fanfilcon, formofilcon, verofilcon, kalifilcon, lehfilcon, and serafilcon. Silicone hydrogels can have a water content of more than or less than fifty percent by weight and are typically phase-separated materials. Some commercial silicone hydrogel contact lenses are coated. This invention relates to cosmetic contact lenses made from conventional hydrogels or silicone hydrogels.

[0040] All contact lenses have a central optical zone surrounded by a peripheral zone with a lens edge. This optical zone includes an optical design for correcting refractive errors such as myopia, hyperopia, astigmatism, and presbyopia. The peripheral zone includes a mechanical design to facilitate insertion and removal of the lens from the eye, providing an interface between the optical and mechanical designs, and optionally includes rotational stabilization features for toroidal lenses. The design of the lens edge is also important for comfort.

[0041] The term "cosmetic contact lens" specifically refers to a soft contact lens that alters the appearance of the eye when worn. Cosmetic contact lenses may be made of hydrogel or silicone hydrogel. In cosmetic contact lenses, the peripheral zone also includes a pattern that alters the color and shape of the eye when worn. This pattern is in the form of a ring surrounding the optical zone. The pattern typically covers the iris and is composed of a colorant that absorbs, reflects, or scatters light, thereby altering the perceived color and texture of the iris. By using a white reflective colorant, the pattern may also cover the sclera, thereby brightening its appearance. For individuals who do not require any vision correction, plano cosmetic contact lenses may be worn solely for cosmetic purposes. This invention relates to cosmetic contact lenses having an elliptical dot pattern covering the iris of the eye.

[0042] As used herein, the term "human population" refers to a group or subgroup of a population of any number of subjects equal to or greater than one person, characterized by any demographic and / or geographical means. For example, a human population may be selected from children, adolescents, or adults, or across all age groups, or selected from the globe, continent, country, region, or any combination thereof. Any anatomical structure of the human body,For example, the diameter of the iris of the eye can be measured on individuals within a human population and then averaged across that population. In this way, the average iris diameter can be calculated using any number of human subjects within a defined human population. For custom or personalized cosmetic contact lenses for a single person, the average iris diameter can be calculated by measuring the diameters of the individual's two irises and dividing by two.

[0043] As used herein, the term "elliptical dot pattern" is a pattern composed of elliptical dots. Elliptical dot patterns can be incorporated into cosmetic contact lenses, for example, by transferring the elliptical dot pattern onto a contact lens mold and then encapsulating the pattern into the contact lens during a curing process. An elliptical dot pattern is composed of elliptical dots of an elliptical shape having a major axis and a minor axis. The major axis is the longest diameter of the ellipse passing through the center of the ellipse from one end to the other, while the minor axis is the shortest diameter of the ellipse passing through the center. The major and minor axes are perpendicular to each other. When the major and minor axes are equal, the ellipse is a circle. An elliptical dot pattern can consist of both elliptical dots and circular dots, and they can also be overlapped to form other shapes when more than one printing layer is used.

[0044] The term “negative space” is the space (or two-dimensional area) between the dots of an elliptical dot pattern. In other words, negative space is the unprinted space (or area) between dots. An elliptical dot pattern can be described by its dot pattern or its negative space or both. Both dots and negative space can be intentionally designed elements or features of the pattern.

[0045] As used herein, the term “colorant” refers to both reactive and non-reactive dyes, colorants, and / or pigments used in inks. A colorant is not a visible colorant used to make the contact lens visible in the packaging.

[0046] The term “ink” refers to a dispersion or solution containing at least one colorant for printing an elliptical dot pattern. Inks may include other components that improve the printing process, such as binder polymers, surfactants, etc. The term “clear coating ink” refers to an ink formulation that does not contain any colorant and is used to print a “clear layer” or “clear coating.” The clear layer or clear coating serves as a primer layer on which the pattern is printed using ink. The clear layer may be applied between the contact lens mold or the printed layer.

[0047] The term "bonding polymer" or "bonding copolymer" refers to a component in the ink that bonds with the colorant and thereby makes the ink more stable before, after, or both of printing. The bonding polymer or copolymer controls the rate at which the reactive monomer mixture diffuses into and through the transparent or printed layer.

[0048] The elliptical dot pattern of the present invention is produced by pad printing and consists of elliptical dots and negative space. Elliptical dot patterns are typically presented in two-dimensional space (even if they are ultimately printed on curved surfaces such as contact lens molds), and therefore,Negative space is the unprinted area between points on a two-dimensional image. The relative amount of printed points and negative space can be measured by quantitative image analysis and expressed as a percentage of the total area of ​​a pattern or a portion of a pattern (e.g., within the apparent limbal ring).

[0049] Quantitative image analysis can be performed, for example, in Adobe Illustrator 2023 (version 27.9) and Adobe Photoshop 2024 (version 25.0.0), as described below, to determine the amount of negative space in the outermost ring of an elliptical dot pattern. In Adobe Illustrator, an image of a solid black ring with the desired inner and outer diameters of the outermost ring of the elliptical dot pattern is created. This image is used to determine the total area of ​​the outermost ring. A white image of the elliptical dot pattern is then pasted and centered over the black ring. After selecting both objects, the Intersect option on the Pathfinder panel is clicked to create a black composite image consisting only of the intersecting or overlapping portions of the black ring and the elliptical dot pattern. A 15 mm white circle is created and centered above the composite image. With both objects selected, resize the white circle to 60 mm. Then, delete the enlarged circle. Save the resized composite image as a JPG image file at 300 pixels per inch, resulting in a final output image size of 709 pixels × 709 pixels.

[0050] In Adobe Photoshop, open the black composite image. Then, measure the area of ​​the black composite image by selecting the black area of ​​the composite image using the eyedropper tool in the pop-up window by selecting Color Range from the menu and clicking OK. Open the Measurement Log by clicking Window / Measurement and then clicking the Record Measurement button to capture the selected black area, which represents the area of ​​the printed elliptical dots in the outermost ring of the pattern. The percentage of the area of ​​the outermost ring with printed elliptical dots is calculated by dividing the recorded black area of ​​the composite image by multiplying the area of ​​the solid black ring created in Adobe Illustrator by 100%. The percentage of the area of ​​the outermost ring as negative space is equal to 100% minus the percentage of the area with printed elliptical dots.

[0051] According to one exemplary aspect, the present invention provides a cosmetic contact lens comprising an elliptical dot pattern having a diameter equal to or greater than 8 mm and having a negative space between 70% and 100% in the outermost ring, the outermost ring having a thickness between 0.2 mm and 2.0 mm. As used herein, "outermost ring" refers to a circumferential band around the periphery of the elliptical dot pattern schematically shown in FIG. 1. The elliptical dot pattern may have various features, such as bands, spokes, spikes, waves, nets, spots, etc., depending on the dot density and location, provided that the negative space in the outermost ring of the pattern is between 70% and 100%. In another embodiment,The negative space of the outermost ring is between 80% and 100%. The outermost ring is intended to cover the limbus of the eye. Figures 2 through 4 show exemplary cosmetic contact lenses from a frontal view, a left-side view, and a right-side view, respectively. The dashed line in Figure 2 represents the edge of the cosmetic contact lens.

[0052] The outermost ring may have a thickness between 0.5 mm and 1.5 mm. The diameter of the elliptical dot pattern may be between 9 mm and 14 mm, and preferably between 11 mm and 13 mm.

[0053] According to another exemplary aspect, the present invention provides a cosmetic contact lens comprising an elliptical dot pattern, wherein when the pattern covers the iris of the eye, the negative space of the pattern creates an apparent limbal ring. As used herein, "apparent limbal ring" refers to the cosmetic effect of producing a limbal ring appearance by wearing a cosmetic contact lens having the elliptical dot pattern of the present invention. As described above, the limbal ring is a dark ring surrounding the periphery of the iris, also known as the limbus, creating a distinct boundary between the iris and sclera of the eye, thus providing greater contrast and making the iris appear more colorful. The apparent limbal ring coincides with the outermost ring of the elliptical dot pattern, therefore sharing the same design elements in terms of geometry and negative space. The negative space within the apparent limbal ring can be between 70% and 100%. The negative space within the apparent limbal ring can be between 80% and 100%. The negative space within the apparent limbal ring can increase radially from the center of the lens, and this gradient of negative space can vary at different locations within the elliptical dot pattern. Furthermore, the thickness of the apparent limbal ring can be between 0.2 mm and 2.0 mm, or between 0.5 mm and 1.5 mm.

[0054] The present invention also provides a cosmetic contact lens comprising an elliptical dot pattern including a negative space, wherein when the pattern covers the iris of the eye, the negative space creates an apparent limbal ring, wherein the diameter of the elliptical dot pattern is equal to the average iris diameter of a human population. The average iris diameter can be calculated from a population representing the target cosmetic contact lens wearers and can be found in technical publications.

[0055] The present invention also provides a cosmetic contact lens comprising an elliptical dot pattern, wherein when the pattern covers the iris of the eye, the negative space of the pattern creates an apparent limbal ring, and wherein the diameter of the elliptical dot pattern is equal to or greater than 8 mm, or between 9 mm and 14 mm, or preferably between 11 mm and 13 mm.

[0056] The apparent limbal ring is formed by a combination of the elliptical dot pattern, the color of the underlying iris in the negative space of the elliptical dot pattern, and the color difference between the elliptical dot pattern and the underlying iris. In 1976,The Illumination Commission developed a color standard for quantitatively comparing differences between colors perceived by humans. This standard, known as the 1976 CIEL*a*b* color space, assigns three-dimensional coordinates (L, a*, b*) to each color. The L* coordinate represents the brightness of the target color from zero (black) to 100 (white). The coordinates a* and b* represent chromaticity, without specific numerical limitations. Negative a* values ​​correspond to the amount of green in the target color, and positive a* values ​​correspond to the amount of red in the target color. On the other hand, negative b* values ​​correspond to the level of blue in the target color, and positive b* values ​​correspond to the level of yellow in the target color. In the 1976 CIEL*a*b* color space, the “ΔE” value (ΔE) is the distance between colors, or more precisely, the distance between color coordinates (L, a*, b*), and is a measure of color difference as perceived by humans. For two colors with 1976 CIEL*a*b* color space coordinates (L*1, a*1, b*1) and (L*2, a*2, b*2), “ΔE” is calculated using Formula I below: Formula I To determine the ΔE value required to form the apparent limbal ring, the L*a*b* values ​​of three different cosmetic contact lenses with gray, gold, or brown elliptical dot patterns were measured on four different colored eye models. Images of the cosmetic contact lenses on the eye models were taken using a digital camera. The color image quality of the images should be at least 140 pixels per inch. The color image of the cosmetic lens of the present invention on the eye model was opened in Adobe Photoshop 2022 (version 23.0.0). Using the color picker tool, points in the limbal region of the iris that do not have any cosmetic pattern were selected. Double-clicking the color box displays a window showing the color selected using the color picker tool. The window shows the color and its corresponding color value, including the L*a*b* value. Display the L*a*b* values ​​and record them as coordinates (L*1, a*1, b*1). Next, using the color picker tool, select points on the area of ​​the beauty pattern where there is virtually no negative space. Open the color window for the selected color, display the L*a*b* values, and record them as coordinates (L*2, a*2, b*2). Then calculate ΔE using Formula I (Microsoft Excel can be used). When the ΔE value is between 23 and 79, preferably between 23 and 54, and more preferably between 34 and 54,The apparent limbal ring is visible.

[0057] The elliptical dots constituting the cosmetic contact lens of the present invention have a major axis between 10 micrometers and 200 micrometers, between 25 micrometers and 150 micrometers, or between 30 micrometers and 120 micrometers. The elliptical dots may also be circles (a circle is an ellipse with equal major and minor axes). The elliptical dot pattern may also include dots of non-elliptical shape.

[0058] The elliptical dot pattern can be formed by pad printing using an ink containing a colorant. The ink may be a dispersion or solution containing at least one colorant up to page 8 / 18 of the specification, CN 122206972 A. The colorant may be a dye, staining agent, and / or pigment, either reactive or non-reactive. The colorant is preferably selected from the group consisting of: iron oxide, titanium dioxide, mica pigment, phthalocyanine, carbazole violet, and combinations thereof. The ink may also contain a binder polymer, surfactant, etc., to improve the printing process. The binder polymer is designed to interact with the colorant, thereby making the ink more stable before, after, or both of printing. The binder polymer can also control the rate at which the reactive monomer mixture diffuses into and through the clear layer or printed layer. The clear coating ink is an ink formulation that does not contain any colorant and is used to print a “clear layer” or “clear coating”. The clear layer or clear coating serves as a primer coating on which the ink is used to print a pattern. The clear layer can be applied between the contact lens mold or the printed layers.

[0059] The elliptical dot pattern can be formed by pad printing using one or more printed layers, each of which is individually composed of the elliptical dot pattern. The printed layers can overlap and produce other geometries. In this way, the elliptical dot pattern can vary radially and circumferentially.

[0060] According to another aspect, the present invention provides a cosmetic contact lens with an elliptical dot pattern made of hydrogel or silicone hydrogel, which may also include or incorporate a visible dye for treatment purposes, an ultraviolet light absorber and / or a high-energy visible light absorber for protecting the eyes from photochemical damage, and an internal wetting agent such as polyamide for increasing water content and comfort.

[0061] Such cosmetic contact lenses may also be coated. Such cosmetic contact lenses may also include an optical zone at the center of the lens in which the elliptical dot pattern is absent. This optical zone may be designed to correct refractive errors such as myopia, hyperopia, astigmatism, and presbyopia.

[0062] Method for Designing an Elliptical Dot Pattern The present invention provides a method for designing an elliptical dot pattern, the method comprising the steps of: (a) selecting a diameter of the elliptical dot pattern, said diameter being equal to or greater than 8 mm; (b) selecting a thickness of the outermost ring of the elliptical dot pattern between 0.2 mm and 2.0 mm; and (c) generating an elliptical dot pattern in the outermost ring having a negative space between 70% and 100%.The elliptical dot pattern surrounds the optical zone. The diameter of the elliptical dot pattern can be between 9 mm and 14 mm or between 11 mm and 13 mm. The thickness of the outermost ring can be between 0.5 mm and 1.5 mm. The negative space of the outermost ring can occupy between 80% and 100%. The diameter of the elliptical dot pattern can be calculated, for example, from a human population.

[0063] Method for Preparing Cosmetic Contact Lenses The present invention also provides a method for preparing cosmetic contact lenses having an elliptical dot pattern suitable for forming an apparent limbal ring. The method includes: (a) transferring an optional clear layer onto the front curved mold of the contact lens mold assembly; (b) transferring one or more printed layers on top of the optional clear layer (if present), or otherwise onto the front curved mold of the contact lens mold assembly, wherein these printed layers form an elliptical dot pattern suitable for forming an apparent limbal ring; (c) dispensing a reactive monomer mixture into the front curved mold; (d) positioning a base curved mold on top of the front curved mold to form a contact lens mold assembly having a cavity in the shape of a contact lens; (e) polymerizing the reactive monomer mixture; (f) removing the cosmetic contact lens from the mold assembly; (g) extracting the cosmetic contact lens; and (h) hydrating the cosmetic contact lens, for example, with an organic aqueous solution or deionized water. In a further step, the cosmetic contact lens may be packaged and sterilized, typically by autoclaving the package containing the cosmetic contact lens in a suitable packaging solution. Examples 1-4 are representative of this manufacturing method. Alternatively, the transfer printing of one or more printed layers may be accomplished using inkjet or dot matrix printing processes.

[0064] An optional transparent layer can be printed on the front curved surface mold of the contact lens mold assembly in any shape or thickness. Preferably, the transparent layer is printed in the shape of a ring surrounding the optical area portion of the front curved surface mold. More information on the use of transparent layers in the manufacture of cosmetic contact lenses can be found in U.S. Patent Nos. 7,832,860 and 9,798,162, the entire contents of which are incorporated herein by reference. Specification 9 / 18 pages 12 CN 122206972 A

[0065] The printed layer can be formed using inks having a variety of colorants, such as iron oxide, titanium dioxide, mica pigments, phthalocyanine, carbazole violet, and combinations thereof. In the absence of a transparent layer, the printed layer is printed directly onto the surface of the front curved surface mold. The ink may contain a binder polymer. The binder polymer is typically prepared from a subset of reactive components used in a reactive monomer mixture. For hydrogels, the binder polymer may be a hydrophilic homopolymer or copolymer. For silicone hydrogels,The binder polymer may comprise: a silicone-containing component and a hydrophilic component. Further information regarding the use of inks containing binder polymers in silicone hydrogels in the manufacture of cosmetic contact lenses can be found in U.S. Patent No. 10,996,491 and U.S. Publication Application No. 2021 / 0079238, the entire contents of which are incorporated herein by reference.

[0066] One property of the printed layers is that they can form an elliptical dot pattern that exhibits a color difference (“ΔE”) between 23 and 79 compared to the color of the iris of the contact lens wearer. The ΔE between the elliptical dot pattern and the iris is preferably between 23 and 54, and more preferably between 34 and 54. In the above method, the reactive monomer mixture may contain only the hydrophilic component for forming the hydrogel, or it may contain one or more silicone-containing components to form the silicone hydrogel.

[0067] Certain aspects of the invention as described herein may be combined in whole or in part. The following provisions set forth some non-limiting embodiments of this disclosure.

[0068] Clause 1. A cosmetic contact lens comprising an elliptical dot pattern, wherein the elliptical dot pattern has a diameter equal to or greater than 8 mm and has a negative space between 70% and 100% in the outermost ring, the outermost ring having a thickness between 0.2 mm and 2.0 mm.

[0069] Clause 2. The cosmetic contact lens of claim 1, wherein the outermost ring has a thickness between 0.5 mm and 1.5 mm.

[0070] Clause 3. The cosmetic contact lens of any one of claims 1 to 2, wherein the diameter of the elliptical dot pattern is between 9 mm and 14 mm.

[0071] Clause 4. The cosmetic contact lens of claim 3, wherein the diameter of the elliptical dot pattern is between 11 mm and 13 mm.

[0072] Clause 5. The cosmetic contact lens of any one of claims 1 to 4, wherein the negative space of the outermost ring is between 80% and 100%.

[0073] Clause 6. A cosmetic contact lens comprising an elliptical dot pattern, wherein when the pattern covers the iris, the negative space of the pattern creates an apparent limbal ring.

[0074] Clause 7. The cosmetic contact lens of claim 6, wherein the negative space within the apparent limbal ring is between 70% and 100%.

[0075] Clause 8. The cosmetic contact lens of claim 7, wherein the negative space within the apparent limbal ring is between 80% and 100%.

[0076] Clause 9. The cosmetic contact lens of any one of claims 6 to 8,The negative space within the apparent limbal ring increases radially from the center of the lens.

[0077] Clause 10. A cosmetic contact lens according to any one of Clauses 6 to 9, wherein the apparent limbal ring has a thickness between 0.2 mm and 2.0 mm.

[0078] Clause 11. A cosmetic contact lens according to Clause 10, wherein the thickness of the apparent limbal ring is between 0.5 mm and 1.5 mm.

[0079] Clause 12. A cosmetic contact lens according to any one of Clauses 6 to 11, wherein the diameter of the elliptical dot pattern is equal to the average iris diameter of the human population.

[0080] Clause 13. A cosmetic contact lens according to any one of Clauses 6 to 12, wherein the diameter of the elliptical dot pattern is equal to or greater than 8 mm.

[0081] Clause 14. A cosmetic contact lens according to Clause 13, wherein the diameter of the elliptical dot pattern is between 9 mm and 14 mm.

[0082] Clause 15. The cosmetic contact lens according to Clause 14, wherein the diameter of the elliptical dot pattern is between 11 mm and 13 mm.

[0083] Clause 16. The cosmetic contact lens according to any one of Clauses 6 to 15, wherein the chromatic aberration (ΔE) between the elliptical dot pattern and the iris is between 23 and 79.

[0084] Clause 17. The cosmetic contact lens according to Clause 16, wherein the chromatic aberration (ΔE) between the elliptical dot pattern and the iris is between 23 and 54.

[0085] Clause 18. The cosmetic contact lens according to Clause 17, wherein the chromatic aberration (ΔE) between the elliptical dot pattern and the iris is between 34 and 54.

[0086] Clause 19. The cosmetic contact lens according to any one of Clauses 1 to 18, wherein the elliptical dot pattern comprises elliptical dots having a major axis between 10 micrometers and 200 micrometers.

[0087] Clause 20. The cosmetic contact lens according to Clause 19, wherein the elliptical dot pattern comprises elliptical dots having a major axis between 25 micrometers and 150 micrometers.

[0088] Clause 21. The cosmetic contact lens according to Clause 20, wherein the elliptical dot pattern comprises elliptical dots having a major axis between 30 micrometers and 120 micrometers.

[0089] Clause 22. The cosmetic contact lens according to any one of Clauses 1 to 21, wherein the elliptical dots are circles.

[0090] Clause 23. The cosmetic contact lens according to any one of Clauses 1 to 22, wherein the elliptical dot pattern further comprises dots of a non-elliptical shape.

[0091] Clause 24. The cosmetic contact lens according to any one of Clauses 1 to 23,The elliptical dot pattern is formed by pad printing using ink containing a colorant.

[0092] Clause 25. The cosmetic contact lens according to Clause 24, wherein the colorant is selected from the group consisting of iron oxide, titanium dioxide, mica pigment, phthalocyanine, carbazole violet, and combinations thereof.

[0093] Clause 26. The cosmetic contact lens according to any one of Clauses 24 to 25, wherein the elliptical dot pattern is formed by pad printing using one or more printing layers, the one or more printing layers being individually composed of the elliptical dot pattern.

[0094] Clause 27. The cosmetic contact lens according to Clause 26, wherein the printing layers overlap and produce other geometries.

[0095] Clause 28. The cosmetic contact lens according to any one of Clauses 1 to 27, wherein the elliptical dot pattern varies radially and circumferentially.

[0096] Clause 29. The cosmetic contact lens according to any one of Clauses 1 to 28, wherein the cosmetic contact lens is made of hydrogel.

[0097] Clause 30. The cosmetic contact lens according to any one of Clauses 1 to 28, wherein the cosmetic contact lens is made of silicone hydrogel.

[0098] Clause 31. The cosmetic contact lens according to any one of Clauses 1 to 30, wherein the cosmetic contact lens is coated. Specification 11 / 18 pages 14 CN 122206972 A

[0099] Clause 32. The cosmetic contact lens according to any one of Clauses 1 to 31, further comprising an optical zone at the center of the lens, wherein there is no elliptical dot pattern in the optical zone.

[0100] Clause 33. The cosmetic contact lens according to Clause 32, wherein the optical zone is designed to correct myopia, hyperopia, astigmatism, or presbyopia.

[0101] Clause 34. A method for designing an elliptical dot pattern for cosmetic contact lenses, the method comprising the steps of: (a) selecting a diameter of the elliptical dot pattern, the diameter being equal to or greater than 8 mm; (b) selecting a thickness of the outermost ring of the elliptical dot pattern between 0.2 mm and 2.0 mm; and (c) generating an elliptical dot pattern having a negative space between 70% and 100% in the outermost ring, wherein the elliptical dot pattern surrounds an optical area.

[0102] Clause 35. The method of Clause 34, wherein the diameter is between 9 mm and 14 mm.

[0103] Clause 36. The method of Clause 35, wherein the diameter is between 11 mm and 13 mm.

[0104] Clause 37. The method of any one of Clauses 34 to 36, wherein the thickness of the outermost ring is between 0.5 mm and 1.5 mm.

[0105] Clause 38. The method of any one of Clauses 34 to 37,The negative space of the outermost ring is between 80% and 100%.

[0106] Clause 39. The method according to any one of Clauses 34 to 38, wherein the diameter is an average diameter calculated from a human population based on demographics, geography, medical conditions, or a combination thereof.

[0107] Clause 40. The method according to Clause 39, wherein the demographics are selected from the group consisting of: age, race, sex, ethnicity, income, and combinations thereof.

[0108] Clause 41. The method according to Clause 39, wherein the geography is selected from the group consisting of: global, continent, country, region, political, and combinations thereof.

[0109] Clause 42. The method according to Clause 39, wherein the medical conditions are selected from the group consisting of: myopia, hyperopia, astigmatism, presbyopia, glaucoma, dry eye syndrome, diabetes, and combinations thereof.

[0110] Clause 43. A method for preparing a cosmetic contact lens having an elliptical dot pattern suitable for forming an apparent limbal ring, the method comprising the steps of: (a) transferring an optional clear layer onto a frontal mold of a contact lens mold assembly; (b) transferring one or more printed layers on top of the optional clear layer (if present), or otherwise onto the frontal mold, wherein the printed layers form an elliptical dot pattern suitable for forming an apparent limbal ring; (c) dispensing a reactive monomer mixture into the frontal mold; (d) positioning a base surface mold on top of the frontal mold to form the contact lens mold assembly having a cavity in the shape of a contact lens; and (e) polymerizing the reactive monomer mixture to form the cosmetic contact lens; (f) removing the cosmetic contact lens from the mold assembly; (g) extracting the cosmetic contact lens; and (h) hydrating the cosmetic contact lens.

[0111] Clause 44. The method according to Clause 43, further comprising the steps of packaging and sterilizing the cosmetic contact lens after the hydration step.

[0112] Clause 45. The method according to Clause 44, wherein the sterilization step is performed by autoclaving the packaged cosmetic contact lens.

[0113] Clause 46. The method according to any one of Clauses 43 to 45, wherein the transparent layer is a ring surrounding the optical region.

[0114] Clause 47. The method according to any one of Clauses 43 to 46, wherein the reactive monomer mixture comprises one or more components containing organosilicon.

[0115] Clause 48. The method according to Clause 47,The transparent layer comprises a polymer made of one or more compounds containing organosilicon. Example

[0116] The following abbreviations will be used throughout the examples and have the following meanings: LED: Light-emitting diode; Wt. %: Weight %; PPM: Parts per million; BC: Base surface plastic mold; FC: Front surface plastic mold; PS: Polystyrene, a homopolymer of styrene used as a plastic mold resin or component, and may contain additives; PP: Polypropylene, a homopolymer of propylene used as a plastic mold resin or component, and may contain additives; TT: Tuftec, a hydrogenated styrene-butadiene block copolymer (Asahi Kasei Chemicals) used as a plastic mold resin or component, and may contain additives; Z: Zeonor, a polycyclic olefin thermoplastic polymer (Nippon Zeon Co Ltd) used as a plastic mold resin or component, and may contain additives; RMM: Reactive monomer mixture; HEMA: 2-hydroxyethyl methacrylate (Bimax); DMA: N,N-dimethylacrylamide (Jarchem); MAA: Methacrylic acid (Acros); mPDMS 1000: Mono-n-butyl-terminated monomethacryloyloxypropyl-terminated polydimethylsiloxane (Mn = 1000 g / mol) (Gelest) SiMAA: 2-Acrylic acid, 2-methyl-2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxyl]propoxy]propyl ester (Toray) or 3-(3-(1,1,1,3,5,5,5-heptamethyltrisiloxane-3-yl)propoxy)-2-hydroxypropyl ester EGDMA: Ethylene glycol dimethacrylate (Esstech) TMPTMA: Trimethylolpropane trimethacrylate (Esstech) TEGDMA: Tetraethylene glycol dimethacrylate (Esstech) Omnirad 1700: Bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphine oxide and 2-hydroxy- Mixture of 2-methyl-1-phenyl-prop-1-one Omnirad 1870: bis(2,6-dimethoxybenzoyl)-2,4,4-trimethyl-pentylphosphine oxide and blends. Specification 13 / 18 pages 16 CN 122206972 A AIBN: azobisisobutyronitrile (initiator) DODT: 1-dodecyl mercaptan (chain transfer agent) Norbloc: 2-(2'-hydroxy-5-methacryloyloxyethylphenyl)-2H-benzotriazole (Janssen) 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, PVP, PVP K30, PVP K60, PVP K90: Poly(N-vinylpyrrolidone) (ISP Ashland) DIW: Deionized water IPA: Isopropanol 1E2P: 1-ethoxy-2-propanol IPL: Isopropyl lactate D3O: 3,7-dimethyl-3-octanol (Vigon) 3E3P: 3-ethyl-3-pentanol HEP: 1-(2-hydroxyethyl)-2-pyrrolidone Borate buffer filling solution: The borate buffer filling solution is composed of 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.

[0117] BAGE: Glyceryl borate (molar ratio of boric acid to glycerol is 1:2) In a suitable reactor, 299.3 g (3.2 mol) of glycerol and 99.8 g (1.6 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.

[0118] Titanium dioxide: Cosmetic White C47-060 (Chempilots) Iron oxide black: Sicotit Black 85 E172 (Chempilots) Iron oxide brown: Sicotit Brown 75 E172 (Chempilots) Iron oxide red: Sicotit Red 30 E172 (Chempilots) Iron oxide yellow: Sicotit Yellow 10 E172 (Chempilots) Phthalocyanine blue: Phthalocyanine Blue 15 (Chempilots) Phthalocyanine green: Phthalocyanine Green (Chempilots) Carbazole Violet 23 (Chempilots) Synthesis of binder copolymer (hydrogel) AIBN was used as an initiator and DODT as a chain transfer agent.A binder copolymer having approximately 1.4 wt% MAA repeating units was prepared from HEMA and MAA by free radical polymerization. Copolymerization conditions could be varied to control the composition, molecular weight, and molecular weight distribution of the binder copolymer. The composition was approximately 1.4 wt% MAA repeating units, approximately 96.6 wt% HEMA repeating units, and approximately 2 wt% DODT (binding copolymer #1). The binder copolymer interacted with and stabilized the pigment / dye dispersion.

[0119] Transparent Coating Ink (Hydrogel) A transparent coating was printed onto a front-curved mold using the transparent coating ink. A cosmetic pattern was then transferred onto the transparent coating. The transparent coating ink was prepared by dissolving the binder copolymer #1 in a 4:1 (w / w) solution of IPL:1E2P with a concentration ranging from approximately 20 wt% to approximately 40 wt%. In this example, the concentration of binder copolymer #1 was 30 wt%. The viscosity of the solution could be adjusted as needed by diluting with a 4:1 (w / w) solution of IPL:1E2P or with 1-propanol. 1-Propanol was preferred.

[0120] Preparation of Colored Ink (Hydrogel) Colored inks are prepared by mixing pigments and / or dyes at a certain concentration into a transparent base ink for hydrogel (30% by weight of binder copolymer #1) to impart desired color, pattern, and / or effect in cosmetic contact lenses. The concentration 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 adjust the viscosity or change the evaporation rate. Table A lists six colored ink compositions. The concentration of a specific pigment or dye is listed in weight %. 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 5000 centipoise and about 8000 centipoise, preferably between about 5500 centipoise and 6500 centipoise.

[0121] Table A. Colored Ink Formulation Example 1 (Hydrogel) Cosmetic contact lenses with an elliptical dot pattern were manufactured on an automated pilot production line capable of pad printing and contact lens manufacturing. This elliptical dot pattern was designed to cover the iris and thereby form an apparent limbal ring, wherein the oxygen level was maintained between 0.5% and 5%. The anterior and posterior molds can be made of any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the anterior mold was made of polystyrene, and the posterior mold was made of Zeonor. The anterior and posterior molds were degassed for approximately twelve hours prior to use. A clear coating was printed using a clear coating ink in the ring located between the optical zone and the lens edge and allowed to dry sufficiently (dry enough to deposit the next layer without wrinkling or altering the clear coating).Using colored ink #A1, a printing plate with the pattern shown in FIG. 5C is printed onto a transparent coating. The dot diameter of this first printed layer varies from 50 micrometers to 110 micrometers. After the colored ink #A1 has dried sufficiently, a printing plate with the pattern shown in FIG. 5D is printed onto the transparent coating using colored ink #A2. The average dot diameter of this second printed layer is 63 micrometers.

[0122] Once the printed layer has dried, approximately 100 microliters of RMM are metered into the printed front-curved mold at ambient temperature. The RMM is prepared by dissolving the reactive component in BAGE in 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 a curing chamber at 60°C–70°C. The time between metering the addition of RMM and entering the curing chamber is controlled to allow the RMM to diffuse into the printed layer without smearing. Using a 420 nm LED located above the tray, the RMM is photopolymerized around the printed layer to achieve an intensity of approximately 5 mW / cm² for approximately 4 minutes.

[0123] Table B. Specification for Reactive Monomer Mixtures 15 / 18 pages 18 CN 122206972 A The printed lenses are mechanically demolded, with most of the lenses adhering to the FC and demolded from the BC, and hydrated by immersing the lenses in a DIW containing approximately 800 ppm Tween 80 at 70°C for approximately one hour, followed by equilibration in a borate buffer-filled solution at 70°C for another hour. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The purpose of the lens demolding process is to demold all lenses without defects and to transform from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are transferred to foil heat-sealed blister packs and then sterilized by autoclaving at 124°C for approximately 18 minutes. When the printed lens is placed on an artificial eye with a brown iris, an apparent limbal ring can be seen, as shown in Figure 6C.

[0124] Example 2 (Hydrogel - Predictive) Example 1 was repeated, except that a first printing layer was applied using ink #A3 and a printing plate with the pattern shown in Figure 5C, and a second printing layer was applied using ink #A4 and a printing plate with the pattern shown in Figure 5D.

[0125] Example 3 (Hydrogel - Predictive) Example 1 was repeated, except that a first printing layer was applied using ink #A5 and a printing plate with the pattern shown in Figure 5A, and a second printing layer was applied using ink #A6 and a printing plate with the pattern shown in Figure 5B.

[0126] Synthesis of the binder copolymer (organosilicon hydrogel) An AIBN solution was prepared by dissolving 4 g of AIBN in 300 g of 1-propanol. Before use,The AIBN solution was degassed with nitrogen for 15 to 20 minutes. A monomer solution was prepared by dissolving 98 g of HEMA and 98 g of mPDMS in 91 g of 1-propanol. The monomer solution was degassed with nitrogen for 15 to 20 minutes before use.

[0127] A two-liter jacketed reactor containing 279 g of 1-propanol was heated to 70°C in a water bath under a nitrogen atmosphere. AIBN and the monomer solution were added to the reactor over four hours using a Watson-Marlow pump. The reaction mixture was stirred overnight, then the temperature was lowered to 50°C, and the monomer conversion was monitored by Fourier transform infrared spectroscopy until the carbon-carbon double bond band disappeared. Complete conversion took approximately 24 hours.

[0128] The reaction mixture was transferred to a transparent glass bottle. The copolymer was separated by precipitation into water, filtration, and vacuum drying to obtain approximately 182 g of product (bonded copolymer #2).

[0129] Transparent Coating Ink (Silicone Hydrogel - Preliminary) Transparent coating ink is prepared by dissolving the binder copolymer #2 for silicone hydrogel in a solvent system containing varying amounts of HEP, IPL, D3O and / or 1E2P. The transparent coating ink may also contain various amounts of PVP K60 and PVP K30, especially when the reactive monomer mixture contains PVP K90. Exemplary transparent inks for silicone hydrogel are listed in Table C.

[0130] Table C Specification 16 / 18 pages 19 CN 122206972 A Preparation of Colored Ink (Silicone Hydrogel - Preliminary) Colored ink is prepared by dispersing / dissolving a colorant in one of the transparent coating inks C1-C4 at exemplary concentrations shown in Table D.

[0131] Table D Example 4 (Silicone Hydrogel - Predictive) Cosmetic contact lenses with an elliptical dot pattern were manufactured on an automated pilot production line capable of pad printing and contact lens manufacturing. This elliptical dot pattern was designed to cover the iris and thereby form an apparent limbal ring, wherein the oxygen level was maintained between 0.5% and 5%. The anterior and posterior molds can be made of any polymer; however, homopolymers, copolymers, and blends of PS, PP, TT, and Z are preferred. For example, the anterior mold was made of polystyrene, and the posterior mold was made of Zeonor. The anterior and posterior molds were degassed for approximately twelve hours before use. After printing the annular clear coating with clear coating ink C1 located between the optical zone and the lens edge and drying it sufficiently (dry enough to deposit the next layer without wrinkling or altering the clear coating), a transfer printing plate with the pattern shown in FIG. 5C was printed onto the clear coating using colored ink #D1. After the colored ink #D1 has fully dried, the printing plate with the pattern shown in FIG. 5D is printed onto the transparent coating using the colored ink #D2.

[0132] Once the printed layer has dried,Approximately 100 μL of RMM was metered and added to the printed front-curved mold at ambient temperature. The RMM was prepared by dissolving the reactive component in D3O at the relative amounts listed in Table E to prepare a reactive component and diluent solution (see page 17 / 18 of the instruction manual, 20 CN 122206972 A 77:23 (w / w)). The base-curved mold was then placed on top of the front-curved mold. The tray, including the mold assembly, was then moved into a curing chamber at 60°C–70°C. The time between metered addition of RMM and entry into the curing chamber was controlled to allow the RMM to diffuse into the printed layer without smearing. A 420 nm LED located above the tray was used to photopolymerize the RMM around the printed layer to achieve an intensity of approximately 5 mW / cm² for approximately 4 minutes.

[0133] Table E shows the demolding of the printed lenses, with most of the lenses adhering to the FC, and demolding them by immersing the lenses in 70% IPA for about one or two hours, then washing twice with 70% IPA, optionally twice with 25% IPA, twice with DI, and finally once with a borate-buffered wetting solution. Each washing step lasts about 30 minutes. Those skilled in the art will recognize that the exact lens demolding process can vary depending on the lens formulation and mold material. The purpose of the lens demolding process is to demold all lenses without defects and to transform them from a network swollen by the diluent to a hydrogel swollen by the wetting solution. The lenses are transferred to foil-heat-sealed blister packs and then sterilized by autoclaving at 124°C for about 18 minutes. When the printed lenses are placed on an artificial eye with a brown iris, an apparent limbal ring can be seen, which is similar to the limbal ring shown in Figure 6C. Instruction manual, page 18 / 18, 21 CN 122206972 A, Figure 1, Instruction manual drawing, page 1 / 5, 22 CN 122206972 A, Figure 2, Instruction manual drawing, page 2 / 5, 23 CN 122206972 A, Figure 3, Instruction manual drawing, page 3 / 5, 24 CN 122206972 A, Figure 4, Instruction manual drawing, page 4 / 5, 25 CN 122206972 A, Figure 5, Figure 6, Instruction manual drawing, page 5 / 5, 26 CN 122206972 A,

Claims

1. A cosmetic contact lens comprising an elliptical dot pattern, wherein the elliptical dot pattern has a diameter equal to or greater than 8 mm and has a negative space between 70% and 100% in the outermost ring, the outermost ring having a thickness between 0.2 mm and 2.0 mm.

2. The cosmetic contact lens according to claim 1, wherein, The outermost ring has a thickness between 0.5 mm and 1.5 mm.

3. The cosmetic contact lens according to any one of claims 1 to 2, wherein, The diameter of the elliptical dot pattern is between 9 mm and 14 mm.

4. The cosmetic contact lens according to claim 3, wherein, The diameter of the elliptical dot pattern is between 11 mm and 13 mm.

5. The cosmetic contact lens according to any one of claims 1 to 4, wherein, The negative space in the outermost ring is between 80% and 100%.

6. A cosmetic contact lens comprising an elliptical dot pattern, the elliptical dot pattern including a negative space, wherein when the elliptical dot pattern covers the iris, the negative space creates an apparent limbal ring.

7. The cosmetic contact lens according to claim 6, wherein, The negative space is between 70% and 100%.

8. The cosmetic contact lens according to claim 7, wherein, The negative space is between 80% and 100%.

9. The cosmetic contact lens according to any one of claims 6 to 8, wherein, The negative space increases radially from the center of the lens.

10. The cosmetic contact lens according to any one of claims 6 to 9, wherein, The apparent limbal ring has a thickness between 0.2 mm and 2.0 mm.

11. The cosmetic contact lens according to claim 10, wherein, The thickness of the apparent limbal ring is between 0.5 mm and 1.5 mm.

12. The cosmetic contact lens according to any one of claims 6 to 11, wherein, The diameter of the elliptical dot pattern is equal to the average iris diameter of the human population.

13. The cosmetic contact lens according to any one of claims 6 to 12, wherein, The diameter of the elliptical dot pattern is equal to or greater than 8 millimeters.

14. The cosmetic contact lens according to claim 13, wherein, The diameter of the elliptical dot pattern is between 9 mm and 14 mm.

15. The cosmetic contact lens according to claim 14, wherein, The diameter of the elliptical dot pattern is between 11 mm and 13 mm.

16. The cosmetic contact lens according to any one of claims 6 to 15, wherein, The elliptical dot pattern and the iris exhibit a color difference (ΔE) between 23 and 79.

17. The cosmetic contact lens according to claim 16, wherein, The color difference (ΔE) between the elliptical dot pattern and the iris is between 23 and 54.

18. The cosmetic contact lens according to claim 17, wherein, The color difference (ΔE) between the elliptical dot pattern and the iris is between 34 and 54.

19. The cosmetic contact lens according to any one of claims 1 to 18, wherein, The elliptical dot pattern comprises elliptical dots with a major axis between 10 micrometers and 200 micrometers.

20. The cosmetic contact lens according to claim 19, wherein, The elliptical dot pattern comprises elliptical dots with a major axis between 25 micrometers and 150 micrometers.

21. The cosmetic contact lens according to claim 20, wherein, The elliptical dot pattern comprises elliptical dots with a major axis between 30 micrometers and 120 micrometers.

22. The cosmetic contact lens according to any one of claims 1 to 21, wherein, The elliptical point is a circle.

23. The cosmetic contact lens according to any one of claims 1 to 22, wherein, The elliptical dot pattern also includes dots that are not elliptical in shape.

24. The cosmetic contact lens according to any one of claims 1 to 23, wherein, The elliptical dot pattern is formed by pad printing using ink containing colorant.

25. The cosmetic contact lens according to claim 24, wherein, The colorant is selected from the group consisting of: iron oxide, titanium dioxide, mica pigment, phthalocyanine, carbazole violet, and combinations thereof.

26. The cosmetic contact lens according to any one of claims 24 to 25, wherein, The elliptical dot pattern is formed by pad printing using one or more printing layers, each of which is individually composed of the elliptical dot pattern.

27. The cosmetic contact lens according to claim 26, wherein, The printed layers overlap and produce other geometries.

28. The cosmetic contact lens according to any one of claims 1 to 27, wherein, The elliptical dot pattern varies radially and circumferentially.

29. The cosmetic contact lens according to any one of claims 1 to 28, wherein, The cosmetic contact lenses are made of hydrogel.

30. The cosmetic contact lens according to any one of claims 1 to 28, wherein, The cosmetic contact lenses are made of silicone hydrogel.

31. The cosmetic contact lens according to any one of claims 1 to 30, wherein, The cosmetic contact lenses are coated.

32. The cosmetic contact lens according to any one of claims 1 to 31, further comprising an optical zone at the center of the lens, wherein no elliptical dot pattern exists in the optical zone.

33. The cosmetic contact lens according to claim 32, wherein, The optical zone is designed to correct myopia, hyperopia, astigmatism, or presbyopia.

Images