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

Primary Purpose

Allergic Conjunctivitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Refresh Tears 0.5% Lubricant Eye Drops

Bepreve 1.5% Ophthalmic Solution

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic, conjunctivitis, Allergic conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Minnesota Eye Consultants, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Refresh Tears® eye drops

Bepreve® 1.5% solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

Tear Osmolarity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01346371

First Posted

April 29, 2011

Last Updated

March 19, 2020

Sponsor

Minnesota Eye Consultants, P.A.

Collaborators

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01346371

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Minnesota Eye Consultants, P.A.

Collaborators

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Conjunctivitis

Keywords

Allergic, conjunctivitis, Allergic conjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Refresh Tears® eye drops

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Bepreve® 1.5% solution

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Refresh Tears 0.5% Lubricant Eye Drops

Intervention Type

Drug

Intervention Name(s)

Bepreve 1.5% Ophthalmic Solution

Primary Outcome Measure Information:

Title

Tear Osmolarity

Description

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

Time Frame

56 days after initial screening visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad M Fahmy, O.D.

Organizational Affiliation

Minnesota Eye Consultants

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minnesota Eye Consultants, P.A.

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mneye.com

Description

Minnesota Eye Consultants

Learn more about this trial

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

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