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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346371
Recruitment Status : Unknown
Verified August 2012 by Minnesota Eye Consultants, P.A..
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2011
Last Update Posted : August 8, 2012
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Minnesota Eye Consultants, P.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Bepreve (bepotastine ophthalmic solution) 1.5% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
Study Start Date : May 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye Tears
Drug Information available for: Bepotastine

Arm Intervention/treatment
Placebo Comparator: Refresh Tears® eye drops
Must add drops twice a day every day during trial enrollment.
Experimental: Bepreve® 1.5% solution
Must add drops twice a day every day while enrolled in trial.
Drug: Bepreve (bepotastine ophthalmic solution) 1.5%
Must add drops twice a day every day while enrolled in trial.

Primary Outcome Measures :
  1. Tear Osmolarity [ Time Frame: 56 days after initial screening visit ]
    The TearLab Osmolarity System will be used to assess tear film osmolarity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
  2. 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.
  3. 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.
  4. Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
  5. Are willing/able to follow instructions from the study investigator and his/her staff.
  6. Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff.
  7. Are able to self-administer test article (or have a caregiver available to instill all doses of test article).
  8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

  1. 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.).
  2. 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.
  3. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
  4. Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
  5. Are pregnant or nursing/lactating.
  6. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01346371

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United States, Minnesota
Minnesota Eye Consultants, P.A.
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Minnesota Eye Consultants, P.A.
Bausch & Lomb Incorporated
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Principal Investigator: Ahmad M Fahmy, O.D. Minnesota Eye Consultants

Additional Information:
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Responsible Party: Minnesota Eye Consultants, P.A. Identifier: NCT01346371    
Other Study ID Numbers: MAC-01-11
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Keywords provided by Minnesota Eye Consultants, P.A.:
Allergic conjunctivitis
Additional relevant MeSH terms:
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Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Bepotastine besilate
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Allergic Agents