Allergic Conjunctivitis Clinical Trial
Official title:
The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.
This is a single-center, randomized, parallel group, placebo-controlled study to evaluate the
effect of BEPREVE compared to a placebo eye drop on the measurement of tear film osmolarity
and tear film lipid layer in patients with allergic conjunctivitis.
Subjects will be screened for this study on day one of dosing with the test article. Subjects
who sign the informed consent form and who meet all inclusion/exclusion criteria will be
eligible for participation in this study. They will be assigned sequentially, according to a
computer generated randomization list, in a ratio of 1:1 to receive either BEPREVE™
(bepotastine besilate ophthalmic solution) 1.5% or REFRESH TEARS® Lubricant Eye Drops (1:1).
Subjects will instill one drop of test article either BEPREVE™ or REFRESH TEARS® into the
study eyes twice daily for a maximum of 60 days. Subjects will be seen for evaluation on Days
0, 28±3, and 56±3 following randomization.
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