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Bepotastine Besilate Ophthalmic Solution 1.0% Rapidly Reduces Conjunctival Hyperemia in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):544.
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Bepotastine besilate ophthalmic solution 1.0% is an anti-allergic medication under investigation in the United States with highly selective histamine H1 receptor antagonistic action, stabilization of mast cell function, and inhibitory action on eosinophil infiltration to inflammatory sites. This clinical trial evaluated the efficacy and safety of bepotastine besilate ophthalmic solution 1.0% compared to placebo in alleviating CAC-induced conjunctival hyperemia as a primary efficacy variable at 15 minutes after ophthalmic dosing of investigational product.
The clinical trial was a single-center, randomized, double-masked, placebo-controlled, CAC trial with 5 study visits over 7 weeks. Eligible subjects were assigned randomly to either bepotastine ophthalmic solution 1.0% (n=36) or placebo (n=36). Conjunctival hyperemia was graded on a 0-4 unit scale, with 0.5 unit increments allowed.
Fifteen minutes after ophthalmic dosing, bepotastine besilate ophthalmic solution 1.0% was clinically superior to placebo (P<0.001) at all observation time points for reducing CAC-induced conjunctival hyperemia, with no incidence of treatment emergent ocular adverse events. Only one subject in the study (a placebo treatment group subject) was withdrawn; the reason was non-compliance. Additional follow-up visits were not needed for any of the enrolled subjects.
Bepotastine besilate ophthalmic solution 1.0% was clinically superior to placebo in reducing conjunctival hyperemia in the CAC model of allergic conjunctivitis at 15 minutes after ophthalmic dosing. These results suggest that bepotastine besilate ophthalmic solution 1.0% may be dosed effectively for rapid reduction of conjunctival hyperemia associated with allergic conjunctivitis.
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