Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Tearing at 8 Hours Following Dosing in a Multi-Site Clinical Trial Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Abstract

Purpose: : Bepotastine besilate 1.5% is an investigational ocular medication in the United States with selective histamine H₁ receptor antagonistic action, stabilization of mast cells, and inhibitory action on eosinophilic infiltration to inflammatory sites. This clinical trial evaluated the efficacy and safety of bepotastine besilate ophthalmic solution 1.5% compared to placebo at 8 hours after ophthalmic dosing in reducing signs and symptoms of allergic conjunctivitis, including tearing, using the CAC clinical model.

Methods: : This clinical trial was a multi-center, double-masked, randomized, placebo-controlled, clinical trial that involved 5 study visits over a 7 week period. Eligible subjects were assigned randomly to either bepotastine besilate ophthalmic solution 1.5% (n=43) or placebo (n=43). Tearing was graded as either absent or present.

Results: : Bepotastine besilate 1.5% was statistically superior to placebo at a majority of time points 8 hours after ophthalmic dosing for reducing CAC-induced tearing (P≤0.016). Withdrawn subjects include subjects in both the placebo (n=1) and bepotastine besilate ophthalmic solution 1.5% (n=3) treatment groups. Additional study visits were not needed for any enrolled subjects.

Conclusions: : Bepotastine besilate ophthalmic solution 1.5% was statistically superior to placebo in reducing tearing in the CAC model of allergic conjunctivitis for at least 8 hours after ophthalmic dosing. These results strongly support twice daily dosing in patients for reducing tearing associated with allergic conjunctivitis.

Clinical Trial: : www.clinicaltrials.gov NCT005586664

Keywords: conjunctivitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • drug toxicity/drug effects