Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.

Detailed Description
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This is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of OCS-01 compared to vehicle in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1 to receive OCS-01 or vehicle once daily.

Official Title
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A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Ophthalmic Suspension in the Treatment of Inflammation and Pain Following Cataract Surgery

Conditions
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Cataract, Inflammation Eye, Pain, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone Ophthalmic Suspension
* Other: Vehicle of OCS-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Selection): Provide written informed consent, approved by the appropriate ethics committee; Able to comply with the study requirements and visit schedule; At least 18 years of age of either sex or any race; Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye; Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours post- uncomplicated cataract surgery without vitreous loss]); Exclusion Criteria: Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components; Have only one functional eye (monocular); 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 *Additional inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS-01<br>dexamethasone ophthalmic suspension,1.5% [15 mg/mL] | Drug: Dexamethasone Ophthalmic Suspension<br>* Ophthalmic Suspension,1.5% [15 mg/mL] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).<br>* Other names: OCS-01;|
| Placebo Comparator: Vehicle ophthalmic suspension<br>Vehicle of OCS-01 | Other: Vehicle of OCS-01<br>* inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery | Absence of anterior chamber cells (i.e. score of '0') | Visit 6 (Day 15) | 
| To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery | Absence of pain (i.e. score of '0') | Visit 4 (Day 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ophthalmology, Topical Ophthalmic Solution, Eye Drop, Post-surgical