Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% Improves Morning (AM) Ocular Redness Scores in a Placebo-Controlled Environmental Study of Seasonal Allergic Rhinoconjunctivitis (SAR)

Few studies have assessed the efficacy of ophthalmic antihistamines in reducing ocular redness in environmental conditions. The purpose was to establish the degree of morning ocular redness improvement in a randomized, double-masked, placebo-controlled, clinical trial for subjects with active rhinoconjunctivitis and a history of SAR in a 2-week environmental study following treatment with Bepreve® 1.5% twice daily Eligible subjects with active ocular and nasal allergic symptoms were enrolled. Following randomization, 245 subjects at 12 geographically scattered clinical sites were assigned to placebo or Bepreve 1.5% eyedrops and self-dosed twice daily (AM and PM) for 14 days. Among ocular sign and symptom endpoints, morning ocular redness was graded by subjects on a 0-3 unit scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Subjects recorded the severity of their ocular redness as an instantaneous grade within 15 minutes prior to administration of their morning and evening doses. In the Intent-To-Treat (ITT) population, statistically significant reductions (p<0.05) were consistently seen in instantaneous mean ocular redness morning scores for bepotastine besilate 1.5% (N=123) compared to placebo (N=122) daily, as early as the morning after the first dose, and over the 2-week treatment period. Bepotastine besilate ophthalmic solution 1.5% substantially reduced ocular redness scores when compared to placebo in a 2-week environmental study, consistently achieving statistical significance for reduced instantaneous morning ocular redness on a by-day basis.