NCT05147233

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

A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Oculis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	OCS-01	Dexamethasone ophthalmic suspension, 1.5%
DRUG	Vehicle	Vehicle

Timeline

• Start date: 2022-06-24
• Primary completion: 2023-06-22
• Completion: 2023-07-03
• First posted: 2021-12-07
• Last updated: 2025-07-11
• Results posted: 2025-07-11

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study