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 (OPTIMIZE-1)

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

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: Completed
• Conditions: Inflammation Eye Pain; Postoperative Cataract
• Intervention / Treatment: Drug: Vehicle; Drug: OCS-01

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Oculis Site 16
    • Phoenix, Arizona, United States, 85003
      • Oculis Site 28
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Oculis Site 8
  • California
    • Inglewood, California, United States, 90301
      • Oculis Site 9
    • Newport Beach, California, United States, 92663
      • Oculis Site 23
    • Petaluma, California, United States, 94954
      • Oculis Site 26
    • San Pedro, California, United States, 90731
      • Oculis Site 24
    • Westminster, California, United States, 92683
      • Oculis Site 22
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Oculis Site 11
  • Florida
    • Tamarac, Florida, United States, 33321
      • Oculis Site 12
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Oculis Site 17
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Oculis Site 20
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Oculis Site 5
    • Washington, Missouri, United States, 63090
      • Oculis Site 3
  • North Carolina
    • Kinston, North Carolina, United States, 28501
      • Oculis Site 13
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Oculis Site 6
    • Cincinnati, Ohio, United States, 45242
      • Oculis Site 14
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oculis Site 25
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Oculis Site 7
  • Texas
    • Austin, Texas, United States, 78731
      • Oculis Site 4
    • Houston, Texas, United States, 77025
      • Oculis Site 10
    • San Antonio, Texas, United States, 78229
      • Oculis Site 2
    • San Antonio, Texas, United States, 78229
      • Oculis Site 31
  • Utah
    • Salt Lake City, Utah, United States, 84032
      • Oculis Site 27
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Oculis Site 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oculis
• Investigators: Principal Investigator: Oculis Investigative Site, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Eye Diseases; Lens Diseases; Eye Manifestations; Inflammation; Cataract; Eye Pain; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: DX218

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