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J. A. Gow, J. I. Williams, P. J. Gomes, M. B. Abelson, T. R. McNamara, Bepotastine Ophthalmic Solutions Clinical Study Group; Rhinorrhea Reduction Using BepreveTm Ophthalmic Solution 1.5% in a Clinical Model of Allergic Conjunctivitis: An Analysis of Pooled Data From Two Phase 3 Conjunctival Allergen Challenge (CAC) Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2010;51(13):1915.
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To establish degree of rhinorrhea reduction and the proportion of subjects with clinically significant reduction in rhinorrhea relative to baseline data after dosing with BepreveTM [bepotastine besilate ophthalmic solution (BBOS)] 1.5% compared to placebo at 15 minutes and 8 hours after dosing in the CAC model of allergic conjunctivitis.
The average reduction of rhinorrhea from baseline at 15 minutes after dosing was an average across all time points of 77% in the BBOS 1.5% arm compared to 37% in the placebo arm. Eight hours after dosing, rhinorrhea was reduced an average of 81% in the BBOS 1.5% arm compared to 27% in the placebo arm. The proportion of subjects with a clinically significant reduction in rhinorrhea compared to baseline values (i.e., ≥ 1 unit difference) at 15 minutes after a CAC (the midpoint in the response curve) was 75.0% and 73.6% for BBOS 1.5% 15 minutes and 8 hours post-dose, respectively, and 57.8% and 35.6%, respectively, for placebo.There were no serious adverse events (SAEs) in these studies, and mild eye irritation (3 in each of the BBOS 1.5% and placebo treatment groups), nasopharyngitis (3 in each of the BBOS 1.5% and placebo treatment groups), and mild taste upon instillation (5 in the BBOS 1.5% treatment group) were the most common AEs.
BBOS 1.5% effectively reduced rhinorrhea in the CAC model of allergic conjunctivitis with a favorable benefit/risk profile.
Clinical Trial: :
www.clinicaltrials.gov NCT00586664; NCT00424398
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