Loading clinical trials...

TERMINATEDPHASE3

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

NCT06128369•Oculis

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;

Locations (12)

Oculis Investigative Site

Inglewood, California, United States

Oculis Investigative Site

Morrow, Georgia, United States

Oculis Investigative Site

Louisville, Kentucky, United States

Oculis Investigative Site

St Louis, Missouri, United States

Oculis Investigative Site

Washington, Missouri, United States

Oculis Investigative Site

Elizabeth City, North Carolina, United States

Oculis Investigative Site

Eugene, Oregon, United States

Oculis Investigative Site

Kingston, Pennsylvania, United States

Oculis Investigative Site

Austin, Texas, United States

Oculis Investigative Site

Houston, Texas, United States

Key Dates

Start Date

December 18, 2023

Primary Completion Date

May 2, 2024

Completion Date

May 9, 2024

Last Updated

December 10, 2024

Enrollment

117

ACTUAL participants

Conditions

Inflammation EyePain, PostoperativeCataract

Interventions

Dexamethasone Ophthalmic Suspension

DRUG

Vehicle of OCS-01

OTHER

Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery

NCT06528288

Fusion of Spine, Lumbar RegionAnesthesia, Local+2 more

View study

RECRUITINGNA

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery