Safety Assessment For Cornea With Bepotastine Besilate Ophthalmic Solution 1.5% In A 6-week Safety Clinical Trial

Abstract

Purpose: : 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.

Methods: : 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.

Results: : 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.

Conclusions: : Bepotastine besilate ophthalmic solution 1.5% was safe for the cornea. There were no significant differences in the endothelial cell counts between treatment groups.

Clinical Trial: : http://www.clinicaltrials.gov NCT00586625

Keywords: cornea: clinical science • clinical (human) or epidemiologic studies: outcomes/complications • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials