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James A. Gow, Thomas K. Mundorf, Eugene E. Protzko, Clifford M. Michaelson, Jon I. Williams, Timothy R. McNamara, Bepotastine Besilate Ophthalmic SolutionsStudy Group; Safety Assessment For Cornea With Bepotastine Besilate Ophthalmic Solution 1.5% In A 6-week Safety Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6424.
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To evaluate the safety of bepotastine besilate ophthalmic solution 1.5%, a dual-acting, histamine H1 receptor antagonist and mast cell stabilizer, based upon endothelial cell count and slit lamp biomicroscopy outcomes.
This was a multi-center, randomized, double-masked, placebo-controlled, parallel-group, 6-week, safety clinical trial of bepotastine besilate ophthalmic solution 1.5% (N = 575) or placebo (N = 286) dosed BID daily with healthy pediatric and adult subjects. Corneal edema and cornea erosion (0-3 unit scale) and endothelial condition (0-4 unit scale) were assessed using slit lamp biomicroscopy. A subpopulation of adult subjects with baseline endothelial cell density of ≥ 2200 cells/mm2 underwent specular microscopy at baseline and study visit 5, 12 weeks after initiating dosing.
Bepotastine besilate ophthalmic solution 1.5% subjects had no significant corneal changes from baseline or endothelial cell counts at baseline (P = 0.22) or at exit visit (P = 0.14). No subject withdrawals were due to corneal adverse events and no serious adverse events were reported.
Bepotastine besilate ophthalmic solution 1.5% was safe for the cornea. There were no significant differences in the endothelial cell counts between treatment groups.
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