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

NCT01346371 | Completed Phase 4 Results DMC

• 1 other identifier: MAC-01-11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis

Keywords

Allergic; conjunctivitis; Allergic conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Tear Osmolarity

  The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.

  56 days after initial screening visit

Study Arms (2)

Refresh Tears® eye drops

PLACEBO COMPARATOR

Must add drops twice a day every day during trial enrollment.

Drug: Bepreve 1.5% Ophthalmic Solution

Bepreve® 1.5% solution

EXPERIMENTAL

Must add drops twice a day every day while enrolled in trial.

Drug: Refresh Tears 0.5% Lubricant Eye Drops

Interventions

Refresh Tears 0.5% Lubricant Eye Drops DRUG

Bepreve® 1.5% solution

Bepreve 1.5% Ophthalmic Solution DRUG

Refresh Tears® eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Minnesota Eye Consultants, P.A.: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Minnesota Eye Consultants, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Related Links

• Minnesota Eye Consultants

MeSH Terms

Conditions

Conjunctivitis, Allergic; Conjunctivitis

Interventions

Lubricant Eye Drops; bepotastine besilate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Ahmad Fahmy, OD
• Organization: Minnesota Eye Consultants, P.A.

amfahmy@mneye.com

612-813-3665

Study Officials

• Ahmad M Fahmy, O.D.

  Minnesota Eye Consultants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Locations

US (1)