OCS-01: 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
Phase 3
Recruiting
- Conditions
- Disorders of the Eye Following Cataract Surgery
- Interventions
- Drug: DexamethasoneDrug: Vehicle Placebo
- Registration Number
- NCT05147233
- Lead Sponsor
- Oculis
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
- Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]).
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Exclusion Criteria
- Have any intraocular inflammation (e.g. white blood cells or flare)present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit lamp examination;
- Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment Arm Dexamethasone OCS-01 (Ophthalmic Suspension) - topical use Vehicle Placebo Arm Vehicle Placebo Vehicle
- Primary Outcome Measures
Name Time Method Number of Participants With an Absence of Anterior Chamber Inflammation Day 15 Absence of cells (i.e., score of ´0´) in the anterior chamber of the study eye at Day 15 (Visit 6)
Number of Participants With an Absence of Ocular Pain Day 4 Absence of pain (i.e., score of ´0´) in the study eye at Day 4 (Visit 4)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oculis Investigative Site
🇺🇸Houston, Texas, United States