Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
Detailed Description
Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be follow...
Eligibility Criteria
Inclusion
- Dry eye disease diagnosis
- VAS eye dryness severity score ≥ 30.
Exclusion
- Are unwilling to discontinue use of contact lenses
- Are unwilling to withhold use of artificial tears.
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04362670
Start Date
April 23 2020
End Date
August 11 2021
Last Update
November 14 2023
Active Locations (15)
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1
Ocular Therapeutix, Inc.
Garden Grove, California, United States, 92843
2
Ocular Therapeutix, Inc.
Inglewood, California, United States, 90301
3
Ocular Therapeutix, Inc.
Mission Hills, California, United States, 91345
4
Ocular Therapeutix, Inc.
Delray Beach, Florida, United States, 33484