A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

Completed

• Conditions: Allergic Conjunctivitis

• Registration Number: NCT01339507
• Lead Sponsor: Cunningham, Derek N., O.D., P.A.

Brief Summary

The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

Detailed Description

After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Each patient must meet the following criteria to be enrolled in this study:

1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
2. Have allergic ocular symptoms within the last three days.
3. Are willing/able to follow instructions from the study investigator and his/her staff.
4. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study:

1. Have known hypersensitivity to either BEPREVE™ or LASTACAFT® 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. Are pregnant or nursing/lactating.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Derek Cunningham; 🇺🇸 Austin, Texas, United States