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Status:

TERMINATED

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

Lead Sponsor:

Oculis

Collaborating Sponsors:

ORA, Inc.

Conditions:

Inflammation Eye

Pain, Postoperative

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 cata...

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

Exclusion

    Key Trial Info

    Start Date :

    December 18 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 9 2024

    Estimated Enrollment :

    117 Patients enrolled

    Trial Details

    Trial ID

    NCT06128369

    Start Date

    December 18 2023

    End Date

    May 9 2024

    Last Update

    December 10 2024

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Oculis Investigative Site

    Inglewood, California, United States, 90301

    2

    Oculis Investigative Site

    Morrow, Georgia, United States, 30260

    3

    Oculis Investigative Site

    Louisville, Kentucky, United States, 40206

    4

    Oculis Investigative Site

    St Louis, Missouri, United States, 63131