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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05147233•Oculis

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 \[prior to surgery\]).

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.

Locations (25)

Oculis Site 16

Chandler, Arizona, United States

Oculis Site 28

Phoenix, Arizona, United States

Oculis Site 8

Fayetteville, Arkansas, United States

Oculis Site 9

Inglewood, California, United States

Oculis Site 23

Newport Beach, California, United States

Oculis Site 26

Petaluma, California, United States

Oculis Site 24

San Pedro, California, United States

Oculis Site 22

Westminster, California, United States

Oculis Site 11

Fort Collins, Colorado, United States

Oculis Site 12

Tamarac, Florida, United States

Key Dates

Start Date

June 24, 2022

Primary Completion Date

June 22, 2023

Completion Date

July 3, 2023

Last Updated

July 11, 2025

Enrollment

241

ACTUAL participants

Conditions

Inflammation Eye PainPostoperative Cataract

Interventions

OCS-01

DRUG

Vehicle

DRUG