NCT06128369

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Oculis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Inflammation Eye
• Pain, Postoperative
• Cataract

Interventions

Type	Name	Description
DRUG	Dexamethasone Ophthalmic Suspension	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).
OTHER	Vehicle of OCS-01	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).

Timeline

• Start date: 2023-12-18
• Primary completion: 2024-05-02
• Completion: 2024-05-09
• First posted: 2023-11-13
• Last updated: 2024-12-10

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study