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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Minnesota Eye Consultants, P.A..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Minnesota Eye Consultants, P.A.
ClinicalTrials.gov Identifier:
NCT01346371
First received: April 29, 2011
Last updated: August 7, 2012
Last verified: August 2012

April 29, 2011
August 7, 2012
May 2011
August 2012   (final data collection date for primary outcome measure)
Tear Osmolarity [ Time Frame: 56 days after initial screening visit ] [ Designated as safety issue: No ]
The TearLab Osmolarity System will be used to assess tear film osmolarity.
Same as current
Complete list of historical versions of study NCT01346371 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Conjunctivitis
Drug: Bepreve (bepotastine ophthalmic solution) 1.5%
Must add drops twice a day every day while enrolled in trial.
  • 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.
    Intervention: Drug: Bepreve (bepotastine ophthalmic solution) 1.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346371
MAC-01-11
Yes
Minnesota Eye Consultants, P.A.
Minnesota Eye Consultants, P.A.
Bausch & Lomb Incorporated
Principal Investigator: Ahmad M Fahmy, O.D. Minnesota Eye Consultants
Minnesota Eye Consultants, P.A.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP