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

NCT06128369 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: DX220
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Inflammation Eye Pain; Postoperative Cataract

Outcome Measures

Primary Outcomes (2)

• Absence of Anterior Chamber Cells at Visit 6.

  Day 15.

• Absence of Ocular Pain at Visit 4.

  Day 4.

Secondary Outcomes (6)

• Absence of Anterior Chamber Cells at Visits 4 and 5.

  Days 4 and 8.

• Absence of Ocular Pain at Visits 3, 5, and 6.

  Days 2, 8, and 15.

• Absence of Flare at Visits 4, 5, and 6.

  Days 4, 8, and 15.

• Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.

  Days 4, 8, and 15.

• Use of Rescue Medication on or Prior to Each Visit.

  Days 1, 2, 4, 8, 15, and 22.

Study Arms (2)

OCS-01

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

1 drop of vehicle in the study eye QD for 14 days, beginning 1-day post-surgery in the study eye.

Drug: Vehicle

Interventions

OCS-01 DRUG

Dexamethasone ophthalmic suspension, 1.5%

OCS-01

Vehicle DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[prior to surgery\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oculis: lead

Study Sites (24)

Oculis Investigative Site

Glendale, California, 91204, United States

Location

Oculis Investigative Site

Inglewood, California, 90301, United States

Location

Oculis Investigative Site

Newport Beach, California, 92663, United States

Location

Oculis Investigative Site

Torrance, California, 90505, United States

Location

Oculis Investigative Site

Tamarac, Florida, 33321, United States

Location

Oculis Investigative Site

Morrow, Georgia, 30260, United States

Location

Oculis Investigative Site

Northbrook, Illinois, 60062, United States

Location

Oculis Investigative Site

Indianapolis, Indiana, 46240, United States

Location

Oculis Investigative Site

Louisville, Kentucky, 40206, United States

Location

Oculis Investigative Site

Woburn, Massachusetts, 01810, United States

Location

Oculis Investigative Site

St Louis, Missouri, 63131, United States

Location

Oculis Investigative Site

Washington, Missouri, 63090, United States

Location

Oculis Investigative Site

Las Vegas, Nevada, 89145, United States

Location

Oculis Investigative Site

Elizabeth City, North Carolina, 27909, United States

Location

Oculis Investigative Site

Leland, North Carolina, 28451, United States

Location

Oculis Investigative Site

Cincinnati, Ohio, 45242, United States

Location

Oculis Investigative Site

Eugene, Oregon, 97401, United States

Location

Oculis Investigative Site

Erie, Pennsylvania, 16507, United States

Location

Oculis Investigative Site

Kingston, Pennsylvania, 18704, United States

Location

Oculis Investigative Site

Nashville, Tennessee, 37212, United States

Location

Oculis Investigative Site

Austin, Texas, 78731, United States

Location

Oculis Investigative Site

Houston, Texas, 77008, United States

Location

Oculis Investigative Site

San Antonio, Texas, 78229, United States

Location

Oculis Investigative Site

Lynchburg, Virginia, 24502, United States

Location

Limitations and Caveats

The study was terminated due to sponsor decision based on a third party administrative error. As a result, efficacy endpoints are presented descriptively using the safety population defined by treatment received.

Results Point of Contact

• Title: Sharon Klier, M.D., M.S., M.P.H, Chief Development Officer
• Organization: OCULIS Operations SàrI

info@oculis.com

+41 21 711 3970

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 18, 2023
• Primary Completion: May 2, 2024
• Study Completion: May 9, 2024
• Last Updated: July 30, 2026
• Results First Posted: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)