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OCS-01 in Treating Inflammation and Pain in Post-cataract Patients

A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS 01 Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery

NCT04130802•Oculis

View on ClinicalTrials.gov

Summary

The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day \[QD\] or twice a day \[BID\]).

Detailed Description

This is a multi-center, randomized, double-masked, placebo (vehicle)-controlled study, designed to evaluate the efficacy and safety of OCS-01 ophthalmic suspension (QD versus BID) compared to placebo in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1:1 to receive OCS-01 QD, OCS-01 BID, or placebo BID. Subjects will dose 1 drop in the study eye BID for 14 days, beginning 1 day post-surgery in the operated eye. The study will last up to 24 days, including a follow-up visit at Visit 7 (Day 22 ± 2).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide written informed consent, approved by the appropriate ethics committee;
•2. Be able to comply with the study requirements and visit schedule;
•3. Be at least 18 years of age of either sex or any race;
•4. Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
•5. Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post-uncomplicated cataract surgery without vitreous loss\]);
•6. 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 \[prior to surgery\]);
•7. Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 \[prior to surgery\]),

Exclusion Criteria

•1. Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
•2. Be monocular;
•3. 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;
•4. Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye;
•5. Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.

Locations (4)

Medical cennre

Petaluma, California, United States

Medical center

Roseburg, Oregon, United States

Medical center

Houston, Texas, United States

Medical center

San Antonio, Texas, United States

Key Dates

Start Date

September 27, 2019

Primary Completion Date

January 31, 2020

Completion Date

January 31, 2020

Last Updated

September 10, 2025

Enrollment

153

ACTUAL participants

Conditions

Inflammation CornealPain, Postoperative

Interventions

OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OCS-01 in Treating Inflammation and Pain in Post-cataract Patients

Inclusion Criteria

Exclusion Criteria

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