Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery (OPTIMIZE-2)

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Cataract; Inflammation Eye
• Intervention / Treatment: Drug: Dexamethasone Ophthalmic Suspension; Other: Vehicle of OCS-01

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

Study Locations

• United States
  • California
    • Inglewood, California, United States, 90301
      • Oculis Investigative Site
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Oculis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Oculis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Oculis Investigative Site
    • Washington, Missouri, United States, 63090
      • Oculis Investigative Site
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
      • Oculis Investigative Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oculis Investigative Site
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • 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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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; dexamethasone ophthalmic suspension,1.5% [15 mg/mL]	Drug: Dexamethasone Ophthalmic Suspension; Ophthalmic Suspension,1.5% [15 mg/mL] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).; Other Names: OCS-01
Placebo Comparator: Vehicle ophthalmic suspension; Vehicle of OCS-01	Other: Vehicle of OCS-01; inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery	Absence of anterior chamber cells (i.e. score of '0')	Visit 6 (Day 15)
To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery	Absence of pain (i.e. score of '0')	Visit 4 (Day 4)

Collaborators and Investigators

• Sponsor: Oculis
• Collaborators: ORA, Inc.

Study record dates

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 (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Post-surgical; Ophthalmology; Eye Drop; Topical Ophthalmic Solution
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Eye Diseases; Lens Diseases; Pain, Postoperative; Inflammation; Cataract; 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: 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