A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
NCT05147233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241
Last updated 2025-07-11
Summary
This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.
Conditions
- Inflammation Eye Pain
- Postoperative Cataract
Interventions
- DRUG
-
OCS-01
Dexamethasone ophthalmic suspension, 1.5%
- DRUG
-
Vehicle
Vehicle
Sponsors & Collaborators
-
Oculis
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-24
- Primary Completion
- 2023-06-22
- Completion
- 2023-07-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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