Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Tearing 16 Hours Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis

RATIONALE: To establish the safety and efficacy of bepotastine besilate ophthalmic solution 1.5%, a dual-acting histamine H1 receptor antagonist, compared to placebo in reducing tearing at 16 hours after ophthalmic dosing using the Conjunctival Allergen Challenge (CAC) model of allergic conjunctivitis. METHODS: Two CAC clinical trials were each 7 week, double-masked, randomized, placebo-controlled studies. Eligible subjects were assigned randomly to either bepotastine besilate 1.5% (n=78) or placebo (n=79). Tearing as a secondary efficacy endpoint was graded as either absent or present. The principal statistical test for pooled data analysis was Fisher's exact test. RESULTS: In both the Intent-to-Treat population and the Per-Protocol population, statistically significant reduction in tearing (P≤0.0045) was demonstrated for bepotastine besilate ophthalmic solution 1.5% for all observation time points at 16 hours post-dosing. Discontinued subjects included placebo group subjects (n=8) for subject decision/non-compliance, and bepotastine besilate ophthalmic solution 1.5% subjects for subject decision/non-compliance (n=5) or other reasons (n=3). Additional study visits were not needed for any enrolled subjects. CONCULSIONS: Bepotastine besilate ophthalmic solution 1.5% was statistically superior to placebo in reducing tearing based upon the pooled data from 2 CAC clinical trials after ophthalmic dosing. These data support clinical effectiveness for reduction of tearing associated with allergic conjunctivitis in patients dosing with bepotastine besilate ophthalmic solution 1.5%.