Ophthalmic devices for delivery of hydrophobic comfort agents

Abstract

The invention relates to a soft hydrogel contact lens, especially a silicone hydrogel contact lens, which has a capability of delivering a hydrophobic comfort agent into the eye of a wearer. The hydrophobic comfort agent includes without limitation a monoglyceride, a diglyceride, a triglyceride, a glycolipid, a glyceroglycolipid, a sphingolipid, a sphingo-glycolipid, a phospholipid, a fatty acid, a fatty alcohol, a hydrocarbon having a C12-C28 chain in length, a mineral oil, a silicone oil, or a mixture thereof. It can be released from the soft hydrogel contact lens into the eye of a wearer when being worn so as to strengthen and stabilize the tear film lipid layer and alleviate the dryness of the eye.

1 - 9 . (canceled) 
     
     
         10 . An ophthalmic product, comprising:
 a sealed package which include a packaging solution and a soft hydrogel contact lens, wherein the hydrogel contact lens comprises a polymer matrix and a hydrophobic comfort agent which is not covalently linked to the polymer matrix but distributed therein, wherein the polymeric matrix comprises hydrophobic units derived from a silicone-containing monomer or macromer and hydrophilic units derived from a hydrophilic monomer or macromer,   wherein the hydrophobic comfort agent is a monoglyceride, a diglyceride, a triglyceride, or a mixture thereof,   wherein the soft contact lens has a capability of gradually releasing the hydrophobic comfort agent during wear over at least about 4 hours after storing in the packaging solution for at least about one month.   
     
     
         11 . The ophthalmic product of  claim 10 , wherein the soft hydrogel contact lens has at least one property selected from the group consisting of an oxygen permeability of at least about 40 barrers, an elastic modulus of from about 0.2 MPa to about 2.0 MPa, an lonoflux Diffusion Coefficient, D, of at least about 1.5×10 −6  mm 2 /min, a water content of from about 15% to about 70%, a surface hydrophilicity characterized by having an averaged water contact angle of about 90 degrees or less, and combination thereof. 
     
     
         12 - 13 . (canceled) 
     
     
         14 . An ophthalmic product, comprising:
 a sealed package which include a packaging solution and a soft hydrogel contact lens, wherein the hydrogel contact lens comprises a polymer matrix and a hydrophobic comfort agent which is not covalently linked to the polymer matrix but distributed therein, wherein the polymeric matrix comprises hydrophobic units derived from a silicone-containing monomer or macromer and hydrophilic units derived from a hydrophilic monomer or macromer,   wherein the hydrophobic comfort agent comprises a glycolipid, a glyceroglycolipid, or a mixture thereof,   wherein the soft contact lens has a capability of gradually releasing the hydrophobic comfort agent during wear over at least about 4 hours after storing in the packaging solution for at least about one month.   
     
     
         15 . An ophthalmic product, comprising:
 a sealed package which include a packaging solution and a soft hydrogel contact lens, wherein the hydrogel contact lens comprises a polymer matrix and a hydrophobic comfort agent which is not covalently linked to the polymer matrix but distributed therein, wherein the polymeric matrix comprises hydrophobic units derived from a silicone-containing monomer or macromer and hydrophilic units derived from a hydrophilic monomer or macromer,   wherein the hydrophobic comfort agent comprises a sphingolipid, a sphingo-glycolipid, or a mixture thereof,   wherein the soft contact lens has a capability of gradually releasing the hydrophobic comfort agent during wear over at least about 4 hours after storing in the packaging solution for at least about one month.   
     
     
         16 . (canceled) 
     
     
         17 . The ophthalmic product of  claim 11 , wherein the soft hydrogel contact lens further comprises a non-crosslinkable hydrophilic polymer as leachable wetting agent, wherein the non-crosslinkable hydrophilic polymer is: a polyvinylalcohol; polyethylene oxide; a polyethylene-polypropylene block copolymer; a polyamide; a polyimide; a polylactone; polyvinylpyrrolidone; a copolymer of N-vinylpyrrolidone and one or more hydrophilic vinylic monomers; a homopolymer of acrylamide or methacrylamide; a copolymer of acrylamide or methacrylamide with one or more hydrophilic vinylic monomers; a homopolymer of N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide; a copolymer of N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide with one or more hydrophilic vinylic monomers, and a mixture thereof. 
     
     
         18 . The ophthalmic product of  claim 11 , wherein the packaging solution comprises from about 0.01% to about 5% by weight of a viscosity-enhancing polymer, wherein the viscosity-enhancing polymer is a water soluble cellulose ether, a water-soluble polyvinylalcohol, a poly(ethylene oxide) having a molecular weight of from about 2000 to about 10,000,000 daltons, a polyvinylpyrrolidone with a molecular weight of from about 30,000 daltons to about 1,000,000 daltons, a copolymer of vinylpyrrolidone with one or more hydrophilic monomers, or a mixture thereof, wherein the water-soluble cellulose ether is methyl cellulose (MC), ethyl cellulose, hydroxymethylcellulose, hydroxyethyl cellulose (HEC), hydroxypropylcellulose (HPC), hydroxypropylmethyl cellulose (HPMC), or a mixture thereof. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . The ophthalmic product of  claim 14 , wherein the soft hydrogel contact lens has at least one property selected from the group consisting of an oxygen permeability of at least about 40 barrers, an elastic modulus of from about 0.2 MPa to about 2.0 MPa, an lonoflux Diffusion Coefficient, D, of at least about 1.5×10 −6  mm 2 /min, a water content of from about 15% to about 70%, a surface hydrophilicity characterized by having an averaged water contact angle of about 90 degrees or less, and combination thereof. 
     
     
         22 . The ophthalmic product of  claim 21 , wherein the soft hydrogel contact lens further comprises a non-crosslinkable hydrophilic polymer as leachable wetting agent, wherein the non-crosslinkable hydrophilic polymer is: a polyvinylalcohol; polyethylene oxide; a polyethylene-polypropylene block copolymer; a polyamide; a polyimide; a polylactone;
 polyvinylpyrrolidone; a copolymer of N-vinylpyrrolidone and one or more hydrophilic vinylic monomers; a homopolymer of acrylamide or methacrylamide; a copolymer of acrylamide or methacrylamide with one or more hydrophilic vinylic monomers; a homopolymer of N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide; a copolymer of N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide with one or more hydrophilic vinylic monomers, and a mixture thereof.   
     
     
         23 . The ophthalmic product of  claim 21 , wherein the packaging solution comprises from about 0.01% to about 5% by weight of a viscosity-enhancing polymer, wherein the viscosity-enhancing polymer is a water soluble cellulose ether, a water-soluble polyvinylalcohol, a poly(ethylene oxide) having a molecular weight of from about 2000 to about 10,000,000 daltons, a polyvinylpyrrolidone with a molecular weight of from about 30,000 daltons to about 1,000,000 daltons, a copolymer of vinylpyrrolidone with one or more hydrophilic monomers, or a mixture thereof, wherein the water-soluble cellulose ether is methyl cellulose (MC), ethyl cellulose, hydroxymethylcellulose, hydroxyethyl cellulose (HEC), hydroxypropylcellulose (HPC), hydroxypropylmethyl cellulose (HPMC), or a mixture thereof. 
     
     
         24 . The ophthalmic product of  claim 15 , wherein the soft hydrogel contact lens has at least one property selected from the group consisting of an oxygen permeability of at least about 40 barrers, an elastic modulus of from about 0.2 MPa to about 2.0 MPa, an lonoflux Diffusion Coefficient, D, of at least about 1.5×10 −6  mm 2 /min, a water content of from about 15% to about 70%, a surface hydrophilicity characterized by having an averaged water contact angle of about 90 degrees or less, and combination thereof. 
     
     
         25 . The ophthalmic product of  claim 24 , wherein the soft hydrogel contact lens further comprises a non-crosslinkable hydrophilic polymer as leachable wetting agent, wherein the non-crosslinkable hydrophilic polymer is: a polyvinylalcohol; polyethylene oxide; a polyethylene-polypropylene block copolymer; a polyamide; a polyimide; a polylactone;
 polyvinylpyrrolidone; a copolymer of N-vinylpyrrolidone and one or more hydrophilic vinylic monomers; a homopolymer of acrylamide or methacrylamide; a copolymer of acrylamide or methacrylamide with one or more hydrophilic vinylic monomers; a homopolymer of N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide; a copolymer of N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide with one or more hydrophilic vinylic monomers, and a mixture thereof.   
     
     
         26 . The ophthalmic product of  claim 24 , wherein the packaging solution comprises from about 0.01% to about 5% by weight of a viscosity-enhancing polymer, wherein the viscosity-enhancing polymer is a water soluble cellulose ether, a water-soluble polyvinylalcohol, a poly(ethylene oxide) having a molecular weight of from about 2000 to about 10,000,000 daltons, a polyvinylpyrrolidone with a molecular weight of from about 30,000 daltons to about 1,000,000 daltons, a copolymer of vinylpyrrolidone with one or more hydrophilic monomers, or a mixture thereof, wherein the water-soluble cellulose ether is methyl cellulose (MC), ethyl cellulose, hydroxymethylcellulose, hydroxyethyl cellulose (HEC), hydroxypropylcellulose (HPC), hydroxypropylmethyl cellulose (HPMC), or a mixture thereof.