NCT04130802

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Oculis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Inflammation Corneal
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL	OCS-01 eye drops
DRUG	Placebo	Vehicle eye drops

Timeline

• Start date: 2019-09-27
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2019-10-17
• Last updated: 2025-09-10
• Results posted: 2022-03-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study