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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Minnesota Eye Consultants, P.A.
Minneapolis, Minnesota, United States
Tear Osmolarity
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Time frame: 56 days after initial screening visit
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