Methods of treating dry eye syndrome

Abstract

Methods of treating dry eye syndrome (DES) with an effective amount of thymosin beta 4 (Tβ4), Tβ4 fragments, Tβ4 isoforms, Tβ4 derivatives, peptide agents including amino acid sequence LKKTET [SEQ ID NO:1] or LKKTNT [SEQ ID NO:2], or variants thereof are provided. The presently disclosed subject matter provides methods of increasing tear volume, increasing tear film stability, decreasing ocular surface damage, and decreasing ocular discomfort by delivering compositions of thymosin beta 4 or fragments thereof to subjects in need.

What is claimed is: 
     
         1 . A method of improving tear film stability in a subject in need thereof, comprising:
 administering an ophthalmic composition containing from about 0.05% to about 0.1% by weight of an active agent, wherein the active agent is selected from the group consisting of Tβ4, a peptide comprising amino acid sequence LKKTET [SEQ ID NO:1], and a peptide comprising amino acid sequence LKKTNT [SEQ ID NO:2], wherein the subject has a tear film break up time of less than 10 seconds, wherein the subject has a lower tear film stability as compared to the subject having higher tear film stability, wherein the tear film stability is associated with dry eye syndrome, and wherein the subject has a mean change in a tear film break up time that is more than twice that of the subject having higher tear film stability.   
     
     
         2 . The method of  claim 1 , wherein the ophthalmic composition is formulated as a solution, suspension, semi-liquid, semi-solid gel, gel, ointment, or cream. 
     
     
         3 . The method of  claim 2 , wherein the solution is administered to the subject in a form of eye drops. 
     
     
         4 . The method of  claim 3 , wherein a dosage for one eye can be about 1 to about 5 drops of the eye drops, wherein each drop includes about 10 μl to about 150 μl of the ophthalmic composition. 
     
     
         5 . The method of  claim 2 , wherein the ophthalmic composition is formulated into a unit dosage form to provide a total daily dosage of from about 0.08 ml to about 2.0 ml. 
     
     
         6 . The method of  claim 1 , further comprising administering artificial tears to an affected eye of the subject. 
     
     
         7 . The method of  claim 6 , wherein the artificial tears are administered simultaneously with the ophthalmic composition. 
     
     
         8 . The method of  claim 6 , wherein the artificial tears and the ophthalmic composition are administered sequentially. 
     
     
         9 . The method of  claim 1 , wherein the ophthalmic composition is administered to the subject at least once per day but no more than four times per day. 
     
     
         10 . A method of improving ocular discomfort in a subject in need thereof, comprising:
 administering an ophthalmic composition containing from about 0.05% to about 0.1% by weight of an active agent, wherein the active agent is selected from the group consisting of Tβ4, a peptide comprising amino acid sequence LKKTET [SEQ ID NO:1], and a peptide comprising amino acid sequence LKKTNT [SEQ ID NO:2], wherein the subject has an ocular discomfort score of about 2 or higher, wherein the subject has a higher symptomatic score as compared to a subject having a lower symptomatic score that has an ocular discomfort score less than 2, and wherein the ocular discomfort is associated with dry eye syndrome.   
     
     
         11 . The method of  claim 10 , wherein the ophthalmic composition is formulated as a solution, suspension, semi-liquid, semi-solid gel, gel, ointment, or cream. 
     
     
         12 . The method of  claim 11 , wherein the solution is administered to the subject in a form of eye drops. 
     
     
         13 . The method of  claim 12 , wherein a dosage for one eye can be about 1 to about 5 drops of the eye drops, wherein each drop includes about 10 μl to about 150 μl of the ophthalmic composition. 
     
     
         14 . The method of  claim 11 , wherein the ophthalmic composition is formulated into a unit dosage form to provide a total daily dosage of from about 0.08 ml to about 2.0 ml. 
     
     
         15 . The method of  claim 10 , further comprising administering artificial tears to an affected eye of the subject. 
     
     
         16 . The method of  claim 15 , wherein the artificial tears are administered simultaneously with the ophthalmic composition. 
     
     
         17 . The method of  claim 15 , wherein the artificial tears and the ophthalmic composition are administered sequentially. 
     
     
         18 . The method of  claim 10 , wherein the ophthalmic composition is administered to the subject at least once per day but no more than four times per day.