SILICONE HYDROGEL LENSES WITH WATER-RICH SURFACES

• US 20120026458A1
• Filed: 07/29/2011
• Published: 02/02/2012
• Est. Priority Date: 07/30/2010
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Novartis Ag
• Inventors: Qiu, Yongxing, Pruitt, John Dallas, Tucker, Robert Carey, Nelson, Jared, Thekveli, Sibichen J.
• Granted Patent: US 8,480,227 B2
• Time in Patent Office: Days
• US Class Current: 351/160.H
• CPC Class Codes: B29D 11/00067 Hydrating contact lenses
• CPC Class Codes: C08G 77/388 containing nitrogen
• CPC Class Codes: C08J 2383/04 Polysiloxanes
• CPC Class Codes: C08J 2383/08 containing silicon bound to organic groups containing atoms other than carbon, hydrogen, and oxygen
• CPC Class Codes: C08J 2433/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08J 2433/26 Homopolymers or copolymers of acrylamide or methacrylamide
• CPC Class Codes: C08J 2487/00 Characterised by the use of unspecified macromolecular compounds, obtained otherwise than by polymerisation reactions only involving unsaturated carbon-to-carbon bonds
• CPC Class Codes: C08J 5/00 Manufacture of articles or shaped materials containing macromolecular substances manufacture of semi-permeable membranes B01D67/00 - B01D71/00
• CPC Class Codes: C08J 7/042 with two or more layers, where at least one layer of a composition contains a polymer binder
• CPC Class Codes: C08L 101/14 the macromolecular compounds being water soluble or water swellable, e.g. aqueous gels
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C09D 133/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C09D 133/14 of esters containing halogen, nitrogen, sulfur or oxygen atoms in addition to the carboxy oxygen
• CPC Class Codes: C09D 133/26 Homopolymers or copolymers of acrylamide or methacrylamide
• CPC Class Codes: C09D 171/02 Polyalkylene oxides
• CPC Class Codes: C09D 177/06 Polyamides derived from polyamines and polycarboxylic acids C09D177/10 takes precedence
• CPC Class Codes: C09D 5/1637 Macromolecular compounds
• CPC Class Codes: C09D 5/1681 Antifouling coatings characterised by surface structure, e.g. for roughness effect giving superhydrophobic coatings or Lotus effect
• CPC Class Codes: G02B 1/043 Contact lenses
• CPC Class Codes: G02B 1/10 Optical coatings produced by application to, or surface treatment of, optical elements G02B1/08 takes precedence
• CPC Class Codes: G02B 1/18 : Coatings for keeping optical surfaces clean, e.g. hydrophobic or photo-catalytic films G02B1/16 takes precedence
• CPC Class Codes: G02C 2202/06 : Special ophthalmologic or optometric aspects
• CPC Class Codes: G02C 2202/16 : Laminated or compound lenses
• CPC Class Codes: G02C 7/049 : Contact lenses having special fitting or structural features achieved by special materials or material structures

Abstract

The invention is related to a hydrated silicone hydrogel contact lens having a layered structural configuration: a lower water content silicone hydrogel core (or bulk material) completely covered with a layer of a higher water content hydrogel totally or substantially free of silicone. A hydrated silicone hydrogel contact lens of the invention possesses high oxygen permeability for maintaining the corneal health and a soft, water-rich, lubricious surface for wearing comfort.

Claims

1. A hydrated silicone hydrogel contact lens, comprising:

an anterior surface and an opposite posterior surface; and

a layered structural configuration from the anterior surface to the posterior surface,

wherein the layered structural configuration includes an anterior outer hydrogel layer, an inner layer of a silicone hydrogel material, and a posterior outer hydrogel layer,

wherein the silicone hydrogel material has an oxygen permeability (Dk) of at least about 50 Barrers, and a first water content (designated as WC_SiHy) of from about 10% to about 70% by weight,

wherein the anterior and posterior outer hydrogel layers are substantially uniform in thickness and merge at the peripheral edge of the contact lens to completely enclose the inner layer of the silicone hydrogel material,

wherein the anterior and posterior outer hydrogel layers independent of each other have a second water content higher than WC_SiHy, as characterized either (a) by having a water-swelling ratio (WSR) of at least about 100% if WC_SiHy 45% or (b) by having a water-swelling ratio of at least about

2. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 150% if WC_SiHy 55%.

3. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 200% if WC_SiHy 60%.

4. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 250% if WC_SiHy 65%.

5. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 300%.

6. The hydrated silicone hydrogel contact lens of claim 1, wherein the silicone hydrogel material has an oxygen permeability (Dk) of at least about 70, and a first water content (WC_SiHy) of from about 15% to about 55% by weight, wherein the thickness of each of the anterior and posterior outer hydrogel layers is from about 0.25 μ

m to about 15 μ

m.

7. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers independent of each other have a reduced surface modulus of at least about 20%, relative to the inner layer.

8. The hydrated silicone hydrogel contact lens of claim 7, wherein the thickness of each of the anterior and posterior outer hydrogel layers is from about 0.5 μ

m to about 12.5 μ

m.

9. The hydrated silicone hydrogel contact lens of claim 7, wherein the silicone hydrogel material has an elastic modulus of from about 0.4 MPa to about 1.5 MPa.

10. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior surface has a low surface concentration of negatively-charged groups as characterized by attracting at most about 200 positively-charged particles in positively-charged-particles-adhesion test.

11. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers independently have a thickness of from about 1 μ

m to about 10 μ

m.

12. The hydrated silicone hydrogel contact lens of claim 1, wherein the silicone hydrogel contact lens further comprises, in its layered structural configuration, two transition layers of polymeric material(s), wherein each of the two transition layers is located between the inner layer and one of the anterior and posterior outer hydrogel layers and is substantially uniform in thickness, wherein the thickness of each transition layer is at least about 0.05 μ

m.

13. The hydrated silicone hydrogel contact lens of claim 1, wherein the hydrated silicone hydrogel contact lens has:

a high digital-rubbing resistance as characterized by having no surface cracking lines visible under dark field after the SiHy contact lens is rubbed between fingers.

14. The hydrated silicone hydrogel contact lens of claim 1, wherein the hydrated silicone hydrogel contact lens has a good surface lubricity as characterized by having a critical coefficient of friction of about 0.046 or less.

15. The hydrated silicone hydrogel contact lens of claim 1, wherein the hydrated silicone hydrogel contact lens has a surface hydrophilicity characterized by having a water breakup time of at least about 10 seconds;

a surface wettability characterized by having an averaged water contact angle of about 80 degrees or less;

or combinations thereof.

16. The hydrated silicone hydrogel contact lens of claim 12, wherein the transition layers comprise a carboxyl (COOH)-containing polymer.

17. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers are formed by applying and crosslinking a water-soluble and crosslinkable hydrophilic polymeric material onto a preformed silicone hydrogel contact lens, wherein the preformed silicone hydrogel contact lens comprises amino and/or carboxyl groups on and/or near the surface of the contact lens or a base coating comprising amino and/or carboxyl groups;

wherein the preformed silicone hydrogel contact lens becomes the inner layer after crosslinking.

18. The hydrated silicone hydrogel contact lens of claim 17, wherein the water-soluble and crosslinkable hydrophilic polymeric material is a partially-crosslinked polymeric material that comprises a three-dimensional network and crosslinkable groups within the network.

19. The hydrated silicone hydrogel contact lens of claim 17, wherein the water-soluble and crosslinkable hydrophilic polymeric material comprises (i) from about 20% to about 95% by weight of first polymer chains derived from an epichlorohydrin-functionalized polyamine or polyamidoamine, (ii) from about 5% to about 80% by weight of hydrophilic moieties or second polymer chains derived from at least one hydrophilicity-enhancing agent having at least one reactive functional group selected from the group consisting of amino group, carboxyl group, thiol group, and combination thereof, wherein the hydrophilic moieties or second polymer chains are covalently attached to the first polymer chains through one or more covalent linkages each formed between one azetitdinium group of the epichlorohydrin-functionalized polyamine or polyamidoamine and one amino, carboxyl or thiol group of the hydrophilicity-enhancing agent, and (iii) azetidinium groups which are parts of the first polymer chains or pendant or terminal groups covalently attached to the first polymer chains.

20. The hydrated silicone hydrogel contact lens of claim 19, wherein the hydrophilic polymer as the hydrophilicity-enhancing agent is:

PEG-NH₂;

PEG-SH;

PEG-COOH;

H₂N-PEG-NH₂;

HOOC-PEG-COOH;

HS-PEG-SH;

H₂N-PEG-COOH;

HOOC-PEG-SH;

H₂N-PEG-SH;

multi-arm PEG with one or more amino, carboxyl or thiol groups;

PEG dendrimers with one or more amino, carboxyl or thiol groups;

a diamino-, dicarboxyl-, monoamino- or monocarboxyl-terminated homo- or co-polymer of a non-reactive hydrophilic vinylic monomer;

a copolymer which is a polymerization product of a composition comprising (1) about 60% by weight or less by weight of at least one reactive vinylic monomer and (2) at least one non-reactive hydrophilic vinylic monomer;

or combinations thereof, wherein PEG is a polyethylene glycol segment, wherein the reactive vinylic monomer is selected from the group consisting of amino-C₁-C₆ alkyl (meth)acrylate, C₁-C₆ alkylamino-C₁-C₆ alkyl (meth)acrylate, allylamine, vinylamine, amino-C₁-C₆ alkyl (meth)acrylamide, C₁-C₆ alkylamino-C₁-C₆ alkyl (meth)acrylamide, acrylic acid, C₁-C₄ alkylacrylic acid, N,N-2-acrylamidoglycolic acid, beta-methyl-acrylic acid, alpha-phenyl acrylic acid, beta-acryloxy propionic acid, sorbic acid, angelic acid, cinnamic acid, 1-carobxy-4-phenyl butadiene-1,3, itaconic acid, citraconic acid, mesaconic acid, glutaconic acid, aconitic acid, maleic acid, fumaric acid, tricarboxy ethylene, and combinations thereof, wherein the non-reactive vinylic monomer is selected from the group consisting of acrylamide, methacrylamide, N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, N-vinylpyrrolidone, N,N,-dimethylaminoethylmethacrylate, N,N-dimethylaminoethylacrylate, N,N-dimethylaminopropylmethacrylamide, N,N-dimethylaminopropylacrylamide, glycerol methacrylate, 3-acryloylamino-1-propanol, N-hydroxyethyl acrylamide, N-[tris(hydroxymethyl)methyl]-acrylamide, N-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 2-hydroxyethyl (meth)acrylate, hydroxypropyl (meth)acrylate, a phosphorylcholine-containing vinylic monomer, C₁-C₄-alkoxy polyethylene glycol (meth)acrylate having a weight average molecular weight of up to 1500 Daltons, N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, N-vinyl-N-methyl acetamide, allyl alcohol, vinyl alcohol (hydrolyzed form of vinyl acetate in the copolymer), and combinations thereof.

21. The hydrated silicone hydrogel contact lens of claim 1, wherein the anterior and posterior outer hydrogel layers comprise crosslinkages derived from azetidinium groups in a thermally-induced coupling reaction.

22. The hydrated silicone hydrogel contact lens of claim 1, wherein the silicone hydrogel material is obtained from a silicone hydrogel lens formulation that comprises at least one components selected from the group consisting of a silicone-containing vinylic monomer, a silicone-containing vinylic macromer, a silicone-containing prepolymer, a hydrophilic vinylic monomer, a hydrophobic vinylic monomer, a crosslinking agent, a free-radical initiator, a hydrophilic vinylic macromer/prepolymer, and combination thereof.

23. The hydrated silicone hydrogel contact lens of claim 22, wherein the silicone hydrogel lens formulation comprises:

(1) a hydrophilic vinylic monomer selected from the group consisting of N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, N-vinylpyrrolidone, N-vinyl-N-methyl-acetamide, 1-methyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, hydroxyethylmethacrylate, hydroxyethylacrylate, and combinations thereof; and

(2) a silicone-containing vinylic monomer, a polysiloxane-containing vinylic monomer or macromer, and/or a silicone-containing prepolymer.

24. A hydrated silicone hydrogel contact lens, comprises:

a silicone hydrogel material as bulk material, an anterior surface and an opposite posterior surface,

wherein the contact lens has an oxygen transmissibility of at least about 40 barrers/mm, and a cross-sectional surface-modulus profile,

wherein the cross-sectional surface-modulus profile comprises, along a shortest line between the anterior and posterior surfaces on the surface of a cross section of the contact lens, an anterior outer zone including and near the anterior surface, an inner zone including and around the center of the shortest line, and a posterior outer zone including and near the posterior surface,

wherein the anterior outer zone has an average anterior surface modulus (designated as SM_Ant) while the posterior outer zone has an average posterior surface modulus (designated as SM_Post),

wherein the inner zone has an average inner surface modulus ( SM_Inner),

wherein at least one of

25. The hydrated silicone hydrogel contact lens of claim 24, wherein the anterior and posterior surface has a low surface concentration of negatively-charged groups as characterized by attracting at most about 200 positively-charged particles in positively-charged-particles-adhesion test.

26. The hydrated silicone hydrogel contact lens of any one of claim 24, wherein the hydrated silicone hydrogel contact lens comprises an inner layer of the silicone hydrogel material, an anterior outer hydrogel layer, and a posterior outer hydrogel layer, wherein the anterior and posterior outer hydrogel layers are substantially uniform in thickness and merge at the peripheral edge of the contact lens to completely enclose the inner layer of the silicone hydrogel material, wherein the anterior outer, posterior outer and inner zones in the cross-sectional surface modulus profile represents the anterior outer hydrogel, posterior outer hydrogel and inner layers respectively, wherein the hydrated silicone hydrogel contact lens has a water content (WC_Lens) of from about 10% to about 70% by weight, wherein the anterior and posterior outer hydrogel layers have a thickness of from about 0.1 μ

m to about 20 μ

m, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 100% if the water content (designated as WC_Lens) of the hydrated silicone hydrogel contact lens is 45% or less, or a water-swelling ratio of at least about

27. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 150% if WC_Lens≦

55%.

28. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 200% if WC_Lens≦

60%.

29. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 250% if WC_Lens≦

65%.

30. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 300%.

31. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers independently have a thickness of from about 1 μ

m to about 10 μ

m.

32. The hydrated silicone hydrogel contact lens of claim 26, wherein the silicone hydrogel contact lens further comprises, in its layered structural configuration, two transition layers of polymeric material(s), wherein each of the two transition layers is located between the inner layer and one of the anterior and posterior outer hydrogel layers and is substantially uniform in thickness, wherein the thickness of each transition layer is at least about 0.05 μ

m.

33. The hydrated silicone hydrogel contact lens of claim 24, wherein the hydrated silicone hydrogel contact lens has:

a high digital-rubbing resistance as characterized by having no surface cracking lines visible under dark field after the SiHy contact lens is rubbed between fingers.

34. The hydrated silicone hydrogel contact lens of claim 24, wherein the hydrated silicone hydrogel contact lens has a good surface lubricity as characterized by having a critical coefficient of friction of about 0.046 or less.

35. The hydrated silicone hydrogel contact lens of claim 24, wherein the hydrated silicone hydrogel contact lens has a surface hydrophilicity characterized by having a water breakup time of at least about 10 seconds;

a surface wettability characterized by having an averaged water contact angle of about 80 degrees or less;

or combinations thereof.

36. The hydrated silicone hydrogel contact lens of claim 32, wherein the transition layers comprise a carboxyl (COOH)-containing polymer.

37. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers are formed by applying and crosslinking a water-soluble and crosslinkable hydrophilic polymeric material onto a preformed silicone hydrogel contact lens, wherein the preformed silicone hydrogel contact lens comprises amino and/or carboxyl groups on and/or near the surface of the contact lens or a base coating comprising amino and/or carboxyl groups;

wherein the preformed silicone hydrogel contact lens becomes the inner layer after crosslinking.

38. The hydrated silicone hydrogel contact lens of claim 37, wherein the water-soluble and crosslinkable hydrophilic polymeric material is a partially-crosslinked polymeric material that comprises a three-dimensional network and crosslinkable groups within the network.

39. The hydrated silicone hydrogel contact lens of claim 37, wherein the water-soluble and crosslinkable hydrophilic polymeric material comprises (i) from about 20% to about 95% by weight of first polymer chains derived from an epichlorohydrin-functionalized polyamine or polyamidoamine, (ii) from about 5% to about 80% by weight of hydrophilic moieties or second polymer chains derived from at least one hydrophilicity-enhancing agent having at least one reactive functional group selected from the group consisting of amino group, carboxyl group, thiol group, and combination thereof, wherein the hydrophilic moieties or second polymer chains are covalently attached to the first polymer chains through one or more covalent linkages each formed between one azetitdinium group of the epichlorohydrin-functionalized polyamine or polyamidoamine and one amino, carboxyl or thiol group of the hydrophilicity-enhancing agent, and (iii) azetidinium groups which are parts of the first polymer chains or pendant or terminal groups covalently attached to the first polymer chains.

40. The hydrated silicone hydrogel contact lens of claim 39, wherein the hydrophilic polymer as the hydrophilicity-enhancing agent is:

PEG-NH₂;

PEG-SH;

PEG-COOH;

H₂N-PEG-NH₂;

HOOC-PEG-COOH;

HS-PEG-SH;

H₂N-PEG-COOH;

HOOC-PEG-SH;

H₂N-PEG-SH;

multi-arm PEG with one or more amino, carboxyl or thiol groups;

PEG dendrimers with one or more amino, carboxyl or thiol groups;

a diamino-, dicarboxyl-, monoamino- or monocarboxyl-terminated homo- or co-polymer of a non-reactive hydrophilic vinylic monomer;

a copolymer which is a polymerization product of a composition comprising (1) about 60% by weight or less by weight of at least one reactive vinylic monomer and (2) at least one non-reactive hydrophilic vinylic monomer;

or combinations thereof, wherein PEG is a polyethylene glycol segment, wherein the reactive vinylic monomer is selected from the group consisting of amino-C₁-C₆ alkyl (meth)acrylate, C₁-C₆ alkylamino-C₁-C₆ alkyl (meth)acrylate, allylamine, vinylamine, amino-C₁-C₆ alkyl (meth)acrylamide, C₁-C₆ alkylamino-C₁-C₆ alkyl (meth)acrylamide, acrylic acid, C₁-C₄ alkylacrylic acid, N,N-2-acrylamidoglycolic acid, beta-methyl-acrylic acid, alpha-phenyl acrylic acid, beta-acryloxy propionic acid, sorbic acid, angelic acid, cinnamic acid, 1-carobxy-4-phenyl butadiene-1,3, itaconic acid, citraconic acid, mesaconic acid, glutaconic acid, aconitic acid, maleic acid, fumaric acid, tricarboxy ethylene, and combinations thereof, wherein the non-reactive vinylic monomer is selected from the group consisting of acrylamide, methacrylamide, N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, N-vinylpyrrolidone, N,N,-dimethylaminoethylmethacrylate, N,N-dimethylaminoethylacrylate, N,N-dimethylaminopropylmethacrylamide, N,N-dimethylaminopropylacrylamide, glycerol methacrylate, 3-acryloylamino-1-propanol, N-hydroxyethyl acrylamide, N-[tris(hydroxymethyl)methyl]-acrylamide, N-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 2-hydroxyethyl (meth)acrylate, hydroxypropyl (meth)acrylate, a phosphorylcholine-containing vinylic monomer, C₁-C₄-alkoxy polyethylene glycol (meth)acrylate having a weight average molecular weight of up to 1500 Daltons, N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, N-vinyl-N-methyl acetamide, allyl alcohol, vinyl alcohol (hydrolyzed form of vinyl acetate in the copolymer), and combinations thereof.

41. The hydrated silicone hydrogel contact lens of claim 26, wherein the anterior and posterior outer hydrogel layers comprise crosslinkages derived from azetidinium groups in a thermally-induced coupling reaction.

42. The hydrated silicone hydrogel contact lens of claim 26, wherein the silicone hydrogel material is obtained from a silicone hydrogel lens formulation that comprises at least one components selected from the group consisting of a silicone-containing vinylic monomer, a silicone-containing vinylic macromer, a silicone-containing prepolymer, a hydrophilic vinylic monomer, a hydrophobic vinylic monomer, a crosslinking agent, a free-radical initiator, a hydrophilic vinylic macromer/prepolymer, and combination thereof.

43. The hydrated silicone hydrogel contact lens of claim 42, wherein the silicone hydrogel lens formulation comprises:

(1) a hydrophilic vinylic monomer selected from the group consisting of N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, N-vinylpyrrolidone, N-vinyl-N-methyl-acetamide, 1-methyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, hydroxyethylmethacrylate, hydroxyethylacrylate, and combinations thereof; and

(2) a silicone-containing vinylic monomer, a polysiloxane-containing vinylic monomer or macromer, and/or a silicone-containing prepolymer.

44. A hydrated silicone hydrogel contact lens, comprises:

a silicone hydrogel material as bulk material, an anterior surface and an opposite posterior surface;

wherein the contact lens has (1) an oxygen transmissibility of at least about 40 barrers/mm, and (2) a good surface lubricity as characterized by having a critical coefficient of friction (designated as CCOF) of about 0.046 or less, wherein the anterior and posterior surfaces have a low surface concentration of negatively-charged groups (e.g., carboxylic acid groups) as characterized by attracting at most about 200 positively-charged particles in positively-charged-particles-adhesion test.

45. The hydrated silicone hydrogel contact lens of claim 44, wherein the hydrated silicone hydrogel contact lens comprises an inner layer of the silicone hydrogel material, an anterior outer hydrogel layer, and a posterior outer hydrogel layer, wherein the anterior and posterior outer hydrogel layers are substantially uniform in thickness and merge at the peripheral edge of the contact lens to completely enclose the inner layer of the silicone hydrogel material, wherein the anterior outer, posterior outer and inner zones in the cross-sectional surface modulus profile represents the anterior outer hydrogel, posterior outer hydrogel and inner layers respectively, wherein the hydrated silicone hydrogel contact lens has a water content (WC_Lens) of from about 10% to about 70% by weight, wherein the anterior and posterior outer hydrogel layers have a thickness of from about 0.1 μ

m to about 20 μ

m, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 100% if WC_Lens is 45% or less, or a water-swelling ratio of at least about

46. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 150% if WC_Lens≦

55%.

47. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 200% if WC_Lens≦

60%.

48. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 250% if WC_Lens≦

65%.

49. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independent of each other have a water-swelling ratio of at least about 300%.

50. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independently have a thickness of from about 0.25 μ

m to about 15 μ

m.

51. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independently have a thickness of from about 0.5 μ

m to about 12.5 μ

m.

52. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers independently have a thickness of from about 1 μ

m to about 10 μ

m.

53. The hydrated silicone hydrogel contact lens of claim 45, wherein the silicone hydrogel contact lens further comprises, in its layered structural configuration, two transition layers of polymeric material(s), wherein each of the two transition layers is located between the inner layer and one of the anterior and posterior outer hydrogel layers and is substantially uniform in thickness, wherein the thickness of each transition layer is at least about 0.05 μ

m.

54. The hydrated silicone hydrogel contact lens of claim 44, wherein the hydrated silicone hydrogel contact lens has:

a high digital-rubbing resistance as characterized by having no surface cracking lines visible under dark field after the SiHy contact lens is rubbed between fingers;

55. The hydrated silicone hydrogel contact lens of claim 44, wherein the hydrated silicone hydrogel contact lens has a good surface lubricity as characterized by having a critical coefficient of friction (designated as CCOF) of about 0.043 or less.

56. The hydrated silicone hydrogel contact lens of claim 44, wherein the hydrated silicone hydrogel contact lens has a surface hydrophilicity characterized by having a water breakup time of at least about 10 seconds;

a surface wettability characterized by having an averaged water contact angle of about 90 degrees or less;

or combinations thereof.

57. The hydrated silicone hydrogel contact lens of claim 53, wherein the transition layers comprise a carboxyl (COOH)-containing polymer.

58. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers are formed by applying and crosslinking a water-soluble and crosslinkable hydrophilic polymeric material onto a preformed silicone hydrogel contact lens, wherein the preformed silicone hydrogel contact lens comprises amino and/or carboxyl groups on and/or near the surface of the contact lens or a base coating comprising amino and/or carboxyl groups;

wherein the preformed silicone hydrogel contact lens becomes the inner layer after crosslinking.

59. The hydrated silicone hydrogel contact lens of claim 58, wherein the water-soluble and crosslinkable hydrophilic polymeric material is a partially-crosslinked polymeric material that comprises a three-dimensional network and crosslinkable groups within the network.

60. The hydrated silicone hydrogel contact lens of claim 58, wherein the water-soluble and crosslinkable hydrophilic polymeric material comprises (i) from about 20% to about 95% by weight of first polymer chains derived from an epichlorohydrin-functionalized polyamine or polyamidoamine, (ii) from about 5% to about 80% by weight of hydrophilic moieties or second polymer chains derived from at least one hydrophilicity-enhancing agent having at least one reactive functional group selected from the group consisting of amino group, carboxyl group, thiol group, and combination thereof, wherein the hydrophilic moieties or second polymer chains are covalently attached to the first polymer chains through one or more covalent linkages each formed between one azetitdinium group of the epichlorohydrin-functionalized polyamine or polyamidoamine and one amino, carboxyl or thiol group of the hydrophilicity-enhancing agent, and (iii) azetidinium groups which are parts of the first polymer chains or pendant or terminal groups covalently attached to the first polymer chains.

61. The hydrated silicone hydrogel contact lens of claim 60, wherein the hydrophilic polymer as the hydrophilicity-enhancing agent is:

PEG-NH₂;

PEG-SH;

PEG-COOH;

H₂N-PEG-NH₂;

HOOC-PEG-COOH;

HS-PEG-SH;

H₂N-PEG-COOH;

HOOC-PEG-SH;

H₂N-PEG-SH;

multi-arm PEG with one or more amino, carboxyl or thiol groups;

PEG dendrimers with one or more amino, carboxyl or thiol groups;

a diamino-, dicarboxyl-, monoamino- or monocarboxyl-terminated homo- or co-polymer of a non-reactive hydrophilic vinylic monomer;

a copolymer which is a polymerization product of a composition comprising (1) about 60% by weight or less by weight of at least one reactive vinylic monomer and (2) at least one non-reactive hydrophilic vinylic monomer;

or combinations thereof, wherein PEG is a polyethylene glycol segment, wherein the reactive vinylic monomer is selected from the group consisting of amino-C₁-C₆ alkyl (meth)acrylate, C₁-C₆ alkylamino-C₁-C₆ alkyl (meth)acrylate, allylamine, vinylamine, amino-C₁-C₆ alkyl (meth)acrylamide, C₁-C₆ alkylamino-C₁-C₆ alkyl (meth)acrylamide, acrylic acid, C₁-C₄ alkylacrylic acid, N,N-2-acrylamidoglycolic acid, beta-methyl-acrylic acid, alpha-phenyl acrylic acid, beta-acryloxy propionic acid, sorbic acid, angelic acid, cinnamic acid, 1-carobxy-4-phenyl butadiene-1,3, itaconic acid, citraconic acid, mesaconic acid, glutaconic acid, aconitic acid, maleic acid, fumaric acid, tricarboxy ethylene, and combinations thereof, wherein the non-reactive vinylic monomer is selected from the group consisting of acrylamide, methacrylamide, N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, N-vinylpyrrolidone, N,N,-dimethylaminoethylmethacrylate, N,N-dimethylaminoethylacrylate, N,N-dimethylaminopropylmethacrylamide, N,N-dimethylaminopropylacrylamide, glycerol methacrylate, 3-acryloylamino-1-propanol, N-hydroxyethyl acrylamide, N-[tris(hydroxymethyl)methyl]-acrylamide, N-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 2-hydroxyethyl (meth)acrylate, hydroxypropyl (meth)acrylate, a phosphorylcholine-containing vinylic monomer, C₁-C₄-alkoxy polyethylene glycol (meth)acrylate having a weight average molecular weight of up to 1500 Daltons, N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, N-vinyl-N-methyl acetamide, allyl alcohol, vinyl alcohol (hydrolyzed form of vinyl acetate in the copolymer), and combinations thereof.

62. The hydrated silicone hydrogel contact lens of claim 45, wherein the anterior and posterior outer hydrogel layers comprise crosslinkages derived from azetidinium groups in a thermally-induced coupling reaction.

63. The hydrated silicone hydrogel contact lens of claim 45, wherein the silicone hydrogel material is obtained from a silicone hydrogel lens formulation that comprises at least one components selected from the group consisting of a silicone-containing vinylic monomer, a silicone-containing vinylic macromer, a silicone-containing prepolymer, a hydrophilic vinylic monomer, a hydrophobic vinylic monomer, a crosslinking agent, a free-radical initiator, a hydrophilic vinylic macromer/prepolymer, and combination thereof.

64. The hydrated silicone hydrogel contact lens of claim 63, wherein the silicone hydrogel lens formulation comprises:

(1) a hydrophilic vinylic monomer selected from the group consisting of N,N-dimethylacrylamide, N,N-dimethylmethacrylamide, N-vinylpyrrolidone, N-vinyl-N-methyl-acetamide, 1-methyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, hydroxyethylmethacrylate, hydroxyethylacrylate, and combinations thereof; and

(2) a silicone-containing vinylic monomer, a polysiloxane-containing vinylic monomer or macromer, and/or a silicone-containing prepolymer.