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Phase 4 N=40 Randomized Treatment

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

Allergic Conjunctivitis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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