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

Completed · Phase 2 · Has a placebo group

Conditions studied: Inflammation Corneal, Pain, Postoperative

In brief

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 \[BID\]).

Key facts

Study ID

NCT04130802

Run by

Oculis

People needed

153

Starts

2019-09-27

Expected to finish

2020-01-31

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent, approved by the appropriate ethics committee;
• Be able to comply with the study requirements and visit schedule;
• Be at least 18 years of age of either sex or any race;
• Be planning to 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]);
• 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]);
• Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 [prior to surgery]),

You may not qualify if…

• Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
• Be 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;
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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