The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Refresh Tears® eye drops Must add drops twice a day every day during trial enrollment. |
Drug: Bepreve 1.5% Ophthalmic Solution
|
| Experimental: Bepreve® 1.5% solution Must add drops twice a day every day while enrolled in trial. |
Drug: Refresh Tears 0.5% Lubricant Eye Drops
|
Outcome Measures
Primary Outcome Measures
- Tear Osmolarity [56 days after initial screening visit]
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minnesota Eye Consultants, P.A. | Minneapolis | Minnesota | United States | 55404 |
Sponsors and Collaborators
- Minnesota Eye Consultants, P.A.
- Bausch & Lomb Incorporated
Investigators
- Principal Investigator: Ahmad M Fahmy, O.D., Minnesota Eye Consultants
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MAC-01-11
Study Results
Participant Flow
| Recruitment Details | Recruitment began Aug 15, 2011 and concluded June 11, 2012. There are a variety of sources we recruited our subjects from which is outlined below: Email. PI referrals, employee, and subject referrals. Flyers posted around college campuses. Website clinicaltrial.gov. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution |
|---|---|---|
| Arm/Group Description | Must add drops twice a day every day during trial enrollment. | Must add drops twice a day every day while enrolled in trial. |
| Period Title: Overall Study | ||
| STARTED | 20 | 20 |
| COMPLETED | 18 | 20 |
| NOT COMPLETED | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | Total |
|---|---|---|---|
| Arm/Group Description | Must add drops twice a day every day during trial enrollment. | Must add drops twice a day every day while enrolled in trial. | Total of all reporting groups |
| Overall Participants | 20 | 20 | 40 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
100%
|
20
100%
|
40
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40
(13)
|
35
(12)
|
38
(13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
75%
|
10
50%
|
25
62.5%
|
| Male |
5
25%
|
10
50%
|
15
37.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
20
100%
|
20
100%
|
40
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis per protocol as ITT and LOCF for all subject eyes. |
| Arm/Group Title | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution |
|---|---|---|
| Arm/Group Description | Must add drops twice a day every day during trial enrollment. | Must add drops twice a day every day while enrolled in trial. |
| Measure Participants | 20 | 20 |
| Measure Eyes | 40 | 40 |
| Mean (Standard Deviation) [mOsM/L] |
303
(3.13)
|
303
(2.57)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | ||
| Arm/Group Description | Must add drops twice a day every day during trial enrollment. | Must add drops twice a day every day while enrolled in trial. | ||
All Cause Mortality |
||||
| Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Refresh Tears® Eye Drops | Bepreve® 1.5% Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/20 (50%) | 14/20 (70%) | ||
| Eye disorders | ||||
| Ocular Irritation | 2/20 (10%) | 2 | 1/20 (5%) | 1 |
| Ocular Burning | 5/20 (25%) | 5 | 4/20 (20%) | 4 |
| Ocular itching | 8/20 (40%) | 9 | 7/20 (35%) | 7 |
| General eye discomfort | 1/20 (5%) | 2 | 1/20 (5%) | 3 |
| Gastrointestinal disorders | ||||
| Stomach problems | 1/20 (5%) | 1 | 2/20 (10%) | 2 |
| General disorders | ||||
| Cold like symptoms | 7/20 (35%) | 7 | 4/20 (20%) | 5 |
| Bad Taste in mouth | 0/20 (0%) | 0 | 7/20 (35%) | 7 |
| Musculoskeletal and connective tissue disorders | ||||
| Joint/muscle pain | 1/20 (5%) | 1 | 1/20 (5%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ahmad Fahmy, OD |
|---|---|
| Organization | Minnesota Eye Consultants, P.A. |
| Phone | 612-813-3665 |
| amfahmy@mneye.com |
- MAC-01-11