A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Opthalmic Suspension Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (OPTIMIZE-2)

July 6, 2026 updated by: Oculis

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91204
        • Oculis Investigative Site
      • Inglewood, California, United States, 90301
        • Oculis Investigative Site
      • Newport Beach, California, United States, 92663
        • Oculis Investigative Site
      • Torrance, California, United States, 90505
        • Oculis Investigative Site
    • Florida
      • Tamarac, Florida, United States, 33321
        • Oculis Investigative Site
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Oculis Investigative Site
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Oculis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Oculis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Oculis Investigative Site
    • Massachusetts
      • Woburn, Massachusetts, United States, 01810
        • Oculis Investigative Site
    • Missouri
      • St Louis, Missouri, United States, 63131
        • Oculis Investigative Site
      • Washington, Missouri, United States, 63090
        • Oculis Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Oculis Investigative Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • Oculis Investigative Site
      • Leland, North Carolina, United States, 28451
        • Oculis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oculis Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oculis Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Oculis Investigative Site
      • Kingston, Pennsylvania, United States, 18704
        • Oculis Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Oculis Investigative Site
    • Texas
      • Austin, Texas, United States, 78731
        • Oculis Investigative Site
      • Houston, Texas, United States, 77008
        • Oculis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Oculis Investigative Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Oculis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.
Drug: Vehicle
Vehicle
Experimental: OCS-01
1 drop of OCS-01 (Dexamethasone ophthalmic suspension, 1.5% [15 mg/mL]) in the study eye once daily (QD) for 14 days, beginning 1-day post-surgery in the study eye.
Drug: OCS-01
Dexamethasone ophthalmic suspension, 1.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of Anterior Chamber Cells at Visit 6.
Time Frame: Day 15.
Day 15.
Absence of Ocular Pain at Visit 4.
Time Frame: Day 4.
Day 4.

Secondary Outcome Measures

Outcome Measure
Time Frame
Absence of Anterior Chamber Cells at Visits 4 and 5.
Time Frame: Days 4 and 8.
Days 4 and 8.
Absence of Ocular Pain at Visits 3, 5, and 6.
Time Frame: Days 2, 8, and 15.
Days 2, 8, and 15.
Absence of Flare at Visits 4, 5, and 6.
Time Frame: Days 4, 8, and 15.
Days 4, 8, and 15.
Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.
Time Frame: Days 4, 8, and 15.
Days 4, 8, and 15.
Use of Rescue Medication on or Prior to Each Visit.
Time Frame: Days 1, 2, 4, 8, 15, and 22.
Days 1, 2, 4, 8, 15, and 22.
Use of Rescue Medication Overall.
Time Frame: From first dose until Day 22.
From first dose until Day 22.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculis

Collaborators

ORA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

May 9, 2024

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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