Abstract
Purpose: :
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.
Methods: :
Post hoc
Results: :
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.
Conclusions: :
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
Keywords: conjunctivitis • drug toxicity/drug effects • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials