CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 enrolled
Drug / intervention
OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04130802
NCT04130802Phase 2Completed
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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

Oculis·interventional·Posted Oct 17, 2019·Updated Sep 10, 2025

In Brief

A Phase 2 clinical trial evaluating OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL and Placebo for Inflammation Corneal and Pain, Postoperative. Completed, enrolled 153 participants across 4 sites.

Detailed 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 \[BID\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation Corneal, Pain, Postoperative
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 17, 2019
Enrollment StartSep 27, 2019
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.7 years ago

Interventions

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

OCS-01 eye drops

Placebodrug

Vehicle eye drops