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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Refresh Tears 0.5% Lubricant Eye Drops
* Drug: Bepreve 1.5% Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis. Have documented positive skin prick puncture test to at least one (1) seasonal allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of Visit 1. Agree not to have any other ocular drops in study eyes within 2 days prior to the initiation of dosing with the test article or throughout the duration of the study. Have a Best Corrected Visual Acuity of 20/200 or better in either eye. Are willing/able to follow instructions from the study investigator and his/her staff. Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff. Are able to self-administer test article (or have a caregiver available to instill all doses of test article). Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee. Exclusion Criteria: Have known hypersensitivity to either BEPREVE™ or REFRESH TEARS® or to any component of the test article (including procedural medications such as anesthetic and/or fluorescein drops, dilating drops, etc.). Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening. Have a history of abuse of alcohol/drugs within six months prior to the screening visit. Are pregnant or nursing/lactating. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Refresh Tears® eye drops<br>Must add drops twice a day every day during trial enrollment. | Drug: Bepreve 1.5% Ophthalmic Solution<br> <br> |
| Experimental: Bepreve® 1.5% solution<br>Must add drops twice a day every day while enrolled in trial. | Drug: Refresh Tears 0.5% Lubricant Eye Drops<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Osmolarity | The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L. | 56 days after initial screening visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic, conjunctivitis, Allergic conjunctivitis