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

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.

Timeline

Start

2022-06-24

Primary completion

2023-06-22

Completion

2023-07-03

Outcome

Met primary endpoint

registry analysis (superiority test); OCS-01 vs Vehicle; p <0.0001; Difference in Percentages 33.2 (95% CI 21.5 to 44.9); Wald test NCT05147233 ↗

registry analysis (superiority test); OCS-01 vs Vehicle; p <0.0001; Difference in Percentages 23.5 (95% CI 11.7 to 35.3); Wald test NCT05147233 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OCS-01	Small molecule	1.5 %	Topical

Indications