Ocular Allergy Treatments

Abstract

Compositions, kits and methods for the treatment or prevention of ocular allergies and inflammation and the symptoms thereof comprising alcaftadine or a pharmaceutically acceptable salt thereof.

What is claimed: 
     
         1 . An ophthalmic composition comprising an effective amount of alcaftadine, its pharmaceutically acceptable salts, its N-oxides, hydrates, solvates, polymorphs, pro-drugs, or mixtures thereof. 
     
     
         2 . The composition of  claim 1 , wherein the composition comprises from between about 0.005% to about 10% by weight of alcaftadine, from between about 0.1% by weight to about 0.4% by weight of alcaftadine, or from between about 0.2% to about 0.35% by weight of alcaftadine. 
     
     
         3 . The composition of  claim 1 , wherein the effective amount of alcaftadine is less than about 0.25 mg to greater than about 0.015 mg. 
     
     
         4 . The composition of  claim 1 , wherein the effective amount of alcaftadine is between about 0.075 mg and about 0.125 mg or between less than about 7.1 μg/kg per day and about 3.5 μg/kg per day. 
     
     
         5 . The composition of  claim 1  or  claim 2 , wherein the effective amount of alcaftadine is between about 1.0 mg/mL and about 5.0 mg/mL. 
     
     
         6 . The composition of  claim 5 , wherein the effective amount of alcaftadine is about 2.5 mg/mL. 
     
     
         7 . An ophthalmic composition comprising an effective amount of a compound of Formula II, its pharmaceutically acceptable salts, its N-oxides, hydrates, solvates, polymorphs, pro-drugs, or mixtures thereof, wherein Formula II is 
       
         
           
           
               
               
           
         
       
     
     
         8 . The composition of  claim 7 , wherein the composition comprises from between about 0.005% to about 10% by weight of the compound of Formula II, from between about 0.1% by weight to about 0.4% by weight of the compound of Formula II, or from between about 0.2% to about 0.35% by weight of the compound of Formula II. 
     
     
         9 . The composition of  claim 7 , wherein the effective amount of the compound of Formula II is less than about 0.25 mg to greater than about 0.015 mg. 
     
     
         10 . The composition of  claim 7 , wherein the effective amount of the compound of Formula II is between about 0.075 mg and about 0.125 mg or between less than about 7.1 μg/kg per day and about 3.5 μg/kg per day 
     
     
         11 . The composition of  claim 7 , wherein the effective amount of alcaftadine is between about 1.0 mg/mL and about 5.0 mg/mL. 
     
     
         12 . The composition of  claim 11 , wherein the effective amount of alcaftadine is about 2.5 mg/mL. 
     
     
         13 . A method of treating ocular allergy, the method comprising administering to the eye of a patient in need thereof an effective amount of an ophthalmic composition according to  claim 1 , wherein the administration treats at least one clinical symptom of ocular allergy. 
     
     
         14 . The composition of  claim 13 , wherein the ocular allergy is allergic conjunctivitis. 
     
     
         15 . The composition of  claim 13 , the clinical symptom is a clinical symptom of ocular inflammation. 
     
     
         16 . The composition of  claim 13 , wherein the clinical symptom is ocular itching, ocular redness, swelling of the eyelids, chemosis, tearing, and nasal inflammation, nasal congestion, rhinorrhea, nasal pruritis, ear prurtis, palate prurtis, or sneezing. 
     
     
         17 . The composition of  claim 13 , for the treatment or prevention of at least two clinical symptoms. 
     
     
         18 . The composition of  claim 17 , wherein the at least two clinical symptoms are ocular itching and ocular redness. 
     
     
         19 . The composition of  claim 13 , for the treatment or prevention of at least three clinical symptoms. 
     
     
         20 . The composition of  claim 19 , wherein the at least three clinical symptoms are ocular itching, ocular redness, swelling of the eyelids, chemosis, and tearing. 
     
     
         21 . The composition of  claim 13 , wherein the clinical symptom is a mechanistic symptom associated with ocular allergy or ocular inflammation. 
     
     
         22 . The composition of  claim 21 , wherein the mechanistic symptom is vascular leakage, a reduction in the integrity of the conjunctival epithelial tight junctions, modulation of the H 4  receptor, or mast cell degradation. 
     
     
         23 . The composition of  claim 13 , wherein the clinical symptom is a nasal symptom of ocular allergy or ocular inflammation. 
     
     
         24 . The composition of  claim 23 , wherein the nasal symptom is nasal inflammation, nasal congestion, rhinorrhea, nasal pruritis, or sneezing. 
     
     
         25 . A method of treating ocular allergy, the method comprising administering to the eye of a patient in need thereof an effective amount of an ophthalmic composition according to  claim 7 , wherein the administration treats at least one clinical symptom of ocular allergy.