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F. K. Kurata, T. T. Macejko, E. J. Meier, M. T. Bergmann, E. B. McLaurin, J. I. Williams, J. A. Gow, M. B. Abelson, T. R. McNamara, for the Bepotastine Ophthalmic Solutions Study Group; 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. Invest. Ophthalmol. Vis. Sci. 2009;50(13):6324.
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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.
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.
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 Withdrawn subjects include subjects in both the placebo (n=1) and bepotastine besilate ophthalmic solution 1.5% (n=3) treatment groups.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.
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.
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