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E. E. Protzko, J. I. Williams, J. A. Gow, P. J. Gomes, M. B. Abelson, T. R. McNamara, for the Bepotastine Ophthalmic Solutions Study Group; The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population From Ten to Seventeen Years of Age. Invest. Ophthalmol. Vis. Sci. 2009;50(13):6325.
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Bepotastine besilate ophthalmic solution 1.5% is an anti-allergic medication under investigation in the United States with selective histamine H1 receptor antagonistic action, stabilization of mast cell function, and inhibitory action on eosinophilic infiltration to inflammatory sites. This clinical trial evaluated the safety of bepotastine besilate ophthalmic solution 1.5% dosed twice daily in a healthy pediatric population from 10-17 years of age.
The clinical trial randomization was at a ratio of 2:1 (active:vehicle). The clinical trial was a multi-center, randomized, double-masked, 6-week safety study involving 4 study visits with 2 treatment groups, bepotastine besilate ophthalmic solution 1.5% and placebo. Pediatric subjects represented approximately 15% of the 861 enrolled subjects. Both investigational products were dosed twice daily and the dosing compliance was monitored with dosing diaries. The number of healthy subjects from 10-17 years of age was distributed between bepotastine ophthalmic solution 1.5% (n=40) and placebo (n=15).
All enrolled pediatric subjects completed the study. The frequency of total adverse events (22.5% for bepotastine besilate ophthalmic solution 1.5%; 20% for placebo) and the absolute incidence of ocular adverse events (1 bepotastine besilate ophthalmic solution 1.5% subject and 2 placebo subjects) in subjects from 10-17 years of age were similar for treatment groups. There was no difference between treatment groups in this age range for intraocular pressure (P>0.65), visual acuity (P>0.73), or comfort (P>0.48). No severe adverse events were reported during the clinical trial.
Bepotastine besilate ophthalmic solution 1.5% dosed twice daily for six weeks was safe with minimal adverse events in a healthy pediatric population from 10-17 years of age.
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