NCT01346371

The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer

The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Minnesota Eye Consultants, P.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.

Detailed description

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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Refresh Tears 0.5% Lubricant Eye Drops
DRUG	Bepreve 1.5% Ophthalmic Solution

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-05-03
• Last updated: 2020-03-31
• Results posted: 2020-03-31

Locations

1 site across 1 country: United States