The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population From Ten to Seventeen Years of Age

Abstract

Purpose: : 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.

Methods: : 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).

Results: : 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.

Conclusions: : 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.

Clinical Trial: : www.clinicaltrials.gov NCT00586625

Keywords: conjunctivitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • drug toxicity/drug effects