Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
Lead Sponsor:
Shire
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
Eligibility Criteria
Inclusion
- Patient-reported history of Dry Eye Disease in both eyes.
- Use of over the counter artificial tears within the past 30 days.
- A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
- Able and willing to comply with all study procedures.
Exclusion
- Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
- Unwilling to stop wearing contact lenses during the study.
- LASIK or other ocular surgical procedures within 12 months prior to or during the study.
- Use of prohibited medications
- Significant medical conditions that could affect the study parameters.
Key Trial Info
Start Date :
November 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2015
Estimated Enrollment :
711 Patients enrolled
Trial Details
Trial ID
NCT02284516
Start Date
November 6 2014
End Date
October 5 2015
Last Update
June 11 2021
Active Locations (41)
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1
University of Alabama at Birmingham, UAB School of Optometry
Birmingham, Alabama, United States, 35294
2
Arizona Eye Center
Chandler, Arizona, United States, 85225
3
Sall Research Medical Center
Artesia, California, United States, 90701
4
United Medical Research Institute
Inglewood, California, United States, 90301