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

Completed · Phase 4

Conditions studied: Allergic Conjunctivitis

In brief

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

Key facts

Study ID

NCT01346371

Run by

Minnesota Eye Consultants, P.A.

People needed

40

Starts

2011-05-01

Expected to finish

2012-09-01

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Minnesota Eye Consultants, P.A. — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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