Purchase this article with an account.
Jon I. Williams, Gary D. Berman, Ronald H. Saff, Allan Stillerman, James A. Gow, Timothy R. McNamara, Bepreve Allergic Rhinoconjunctivitis Clinical Study Group; Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% Improves Reflective Ocular Itching Scores in a Placebo-Controlled Natural Exposure Study of Subjects with a Demonstrated History of Seasonal Allergic Rhinoconjunctivitis (SAR). Invest. Ophthalmol. Vis. Sci. 2011;52(14):6418.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To establish the degree of ocular symptom improvement in a randomized, double-masked, placebo-controlled clinical study for subjects with active rhinoconjunctivitis and a history of SAR in a 2-week natural exposure study following treatment with Bepreve® 1.5% twice daily.
Eligible subjects had to display evidence of active ocular and nasal allergic symptoms in order to be enrolled. Following randomization, 245 subjects at 12 clinical sites were assigned to placebo or Bepreve 1.5% eyedrops and self-dosed twice daily (AM and PM) during active allergy season for 14 days. Among efficacy endpoints, reflective ocular itching symptoms were each graded by subjects on a 0-3 unit scale (0 = none, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms).
Statistically significant reductions were seen in reflective mean ocular itching scores for Bepreve 1.5% (N = 109) compared to placebo (N = 108) in the Per Protocol population. Reduction in reflective ocular symptom scores was significantly better with Bepreve 1.5% by ANCOVA analysis over the 2-week treatment period (P = 0.025) and was evident within about 6 days of subject enrollment. Once significance was achieved for the ocular itching endpoint, it generally persisted through the end of the 2-week study period. Rating of a beneficial global therapeutic response at the end of the treatment period by study investigators was statistically superior (P = 0.024) for Bepreve 1.5% treatment compared to placebo.
Bepreve 1.5% reduced reflective ocular itching symptom scores when compared to placebo in a 2-week natural exposure study, achieving statistical significance for reduced ocular itching that was independently supported by determination of an objective clinical response as judged by study investigators.
Clinical Trial: :
This PDF is available to Subscribers Only