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Timothy R. McNamara, Stacey L. Ackerman, Jung T. Dao, Jon I. Williams, James A. Gow, Bepotastine Besilate Ophthalmic Solutions ClinicalStudy Group; The Conjunctival Safety Of Bepotastine Besilate Ophthalmic Solution 1.5% In A Safety Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6414.
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To evaluate the conjunctival safety of bepotastine besilate ophthalmic solution 1.5%, a dual-acting histamine H1 receptor antagonist and mast cell stabilizer, after 6 weeks of twice daily dosing in healthy pediatric and adult subjects.
The clinical trial was a multi-center, randomized, double-masked, placebo-controlled, parallel-group, 6-week safety study dosing bilaterally with bepotastine besilate ophthalmic solution 1.5% or placebo and involving 4 clinic visits. Pediatric subjects ≥ 3 years of age were 14.8% (127/861) of total subjects. Compliance was monitored with dosing diaries. Conjunctival (palpebral and bulbar) hyperemia and chemosis were assessed with slit lamp biomicroscopy examinations and graded on a 0-4 scale.
Bepotastine besilate ophthalmic solution 1.5% subjects had no clinically significant abnormal results compared to placebo. No early withdrawals were due to conjunctival adverse events in the bepotastine besilate ophthalmic solution 1.5% group and no serious adverse events reported.
Bepotastine besilate ophthalmic solution 1.5% dosed for 6 weeks was safe for the conjunctiva in a healthy pediatric and adult population.
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