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

Last updated: December 5, 2024
Sponsor: Oculis
Overall Status: Terminated

Phase

3

Condition

Eye Disorders/infections

Eye Disease

Inflammation

Treatment

Dexamethasone Ophthalmic Suspension

Vehicle of OCS-01

Clinical Study ID

NCT06128369
DX220
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria (Selection):

  • 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 PCIOLimplantation 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

Exclusion Criteria:

  • Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of thestudy medication's components;

  • Have only one functional eye (monocular);

  • Have any intraocular inflammation (e.g., white blood cells or flare) present ineither eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit-lampexamination;

  • Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [priorto surgery]) in the study eye *Additional inclusion/exclusion criteria apply

Study Design

Total Participants: 117
Treatment Group(s): 2
Primary Treatment: Dexamethasone Ophthalmic Suspension
Phase: 3
Study Start date:
December 18, 2023
Estimated Completion Date:
May 09, 2024

Study 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.

Connect with a study center

  • Oculis Investigative Site

    Inglewood, California 90301
    United States

    Site Not Available

  • Oculis Investigative Site

    Morrow, Georgia 30260
    United States

    Site Not Available

  • Oculis Investigative Site

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Oculis Investigative Site

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Oculis Investigative Site

    Washington, Missouri 63090
    United States

    Site Not Available

  • Oculis Investigative Site

    Elizabeth City, North Carolina 27909
    United States

    Site Not Available

  • Oculis Investigative Site

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Oculis Investigative Site

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Oculis Investigative Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Oculis Investigative Site

    Houston, Texas 77008
    United States

    Site Not Available

  • Oculis Investigative Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Oculis Investigative Site

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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