Phase 4
N=40
The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01346371 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Tear Osmolarity — 303; 303 mOsM/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Refresh Tears 0.5% Lubricant Eye Drops (Drug); Bepreve 1.5% Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Minnesota Eye Consultants, P.A.
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Osmolarity |
303; 303 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01346371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.