Compositions, Methods and/or Devices for Prevention and/or Treatment of Dry Eye Disorders

Abstract

The present disclosure relates to compositions, methods and devices for treating, reducing or preventing one or more eye disorders, particularly dry eye disorders, in a subject by administering an amount of one or more fatty acids and/or fatty acid esters therapeutically effective to inhibit lipase activity while permitting bacterial growth or without substantially altering the dynamic microbial community of the eye. Typically, the fatty acids and/or fatty acid esters are C8 to C16 fatty acids and/or fatty acid esters.

1 . A composition for treating or preventing a dry eye disorder in a subject, wherein, the composition comprises an amount of one or more C 8  to C 16  fatty acids and/or fatty acid esters therapeutically effective to inhibit lipase activity in an eye of the subject without substantially altering the dynamic microbial community of the eye. 
     
     
         2 . A composition according to  claim 1  wherein the fatty acids and/or fatty acid esters are C 10  to C 14  fatty acids and/or fatty acid esters. 
     
     
         3 . A composition according to  claim 1 , wherein the fatty acids and/or fatty acid esters are one or more of the following fatty acids and/or fatty acid esters: C 8 , C 10 , C 11 , C 12  or C 14 . 
     
     
         4 . A composition according to  claim 1 , wherein the fatty acids and/or fatty acid esters are selected from the group consisting of capric acid, caprylic acid, myristic acid or combinations thereof. 
     
     
         5 . A composition according to  claim 1 , wherein the fatty acid and/or related fatty acid ester is glycerol monolaurate, lauric acid or a combination thereof. 
     
     
         6 . A composition according to  claim 1  further comprises a therapeutically effective amount of androgen or androgen analogue. 
     
     
         7 . A composition according to  claim 6  wherein the androgen and/or androgen analogue is selected from one or more of the following: dehydroepiandrosterone (DHEA), androsterone, testosterone and dihydrotestosterone. 
     
     
         8 . A composition according to  claim 1  further comprises a therapeutically effective amount of an anti-inflammatory agent. 
     
     
         9 . A composition according to  claim 8  wherein the anti-inflammatory agent is selected from one or more of the following: azithromycin, cyclosporine A, omega-3 fatty acids and transforming growth factor beta (TGF-β). 
     
     
         10 . A composition according to  claim 1 , wherein the composition is suitable for topical administration to an eye. 
     
     
         11 . A composition according to  claim 10 , wherein the topical administration is in the form of an ointment, cream, eye drops or released from an ophthalmic device. 
     
     
         12 . A composition according to  claim 11 , wherein the ophthalmic device is a contact lens. 
     
     
         13 . The composition of  claim 11 , wherein the concentration of fatty acids and/or fatty acid esters is about 0.01 to 50 μg/ml in the eye drops. 
     
     
         14 . The composition of  claim 11  wherein the concentration of fatty acids and/or fatty acid esters is about 0.01 to 50 μg/ml in the composition associated with the contact lens. 
     
     
         15 . The composition of  claim 11  wherein the concentration of fatty acids and/or fatty acid esters is about 0.00001% to 0.005% % by weight of the total volume of the eye drops. 
     
     
         16 . A composition according to  claim 11 , wherein the amount of the fatty acids and/or fatty acid esters included in the ointment or the cream is in a concentration of about 0.005% to 0.05% weight of the total weight of the ointment or the cream. 
     
     
         17 . A composition according to  claim 11 , wherein the amount of glycerol monolaurate included in the eye drops is in a concentration of about 0.01 to 50 μg/ml. 
     
     
         18 . A composition according to  claim 11 , wherein the amount of lauric acid included in eye drops is in a concentration of about 0.01 to 50 μg/ml. 
     
     
         19 . A composition according to  claim 1 , wherein the composition is suitable for oral administration. 
     
     
         20 - 23 . (canceled) 
     
     
         24 . A method for treating or preventing a dry eye disorder in a subject by administering an amount of one or more C 8  to C 16  fatty acids and/or fatty acid esters therapeutically effective to inhibit lipase activity without substantially altering the dynamic microbial community of the eye. 
     
     
         25 - 45 . (canceled)