Allergic Conjunctivitis
Conditions
Keywords
Allergic, conjunctivitis, Allergic conjunctivitis
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.
Interventions
DRUGBepreve 1.5% Ophthalmic Solution
Sponsors
Bausch & Lomb Incorporated
Minnesota Eye Consultants, P.A.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Osmolarity | 56 days after initial screening visit | The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Refresh Tears® Eye Drops Must add drops twice a day every day during trial enrollment. | 20 |
| Bepreve® 1.5% Solution Must add drops twice a day every day while enrolled in trial. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Bepreve® 1.5% Solution | Total | Refresh Tears® Eye Drops |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Continuous | 35 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 13 | 40 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 25 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 20 | 14 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Tear Osmolarity
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Time frame: 56 days after initial screening visit
Population: Analysis per protocol as ITT and LOCF for all subject eyes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears® Eye Drops | Tear Osmolarity | 303 mOsM/L | Standard Deviation 3.13 |
| Bepreve® 1.5% Solution | Tear Osmolarity | 303 mOsM/L | Standard Deviation 2.57 |