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

DX-216

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 \[BID\]).

2019-09-27

2020-01-31

2020-01-31

Completed

Early phase I

153

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.

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2023-01-17