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A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Opthalmic Suspension Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

NCT06128369 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-07-30

Study results available
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Summary

This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.

Conditions

  • Inflammation Eye Pain
  • Postoperative Cataract

Interventions

DRUG

OCS-01

Dexamethasone ophthalmic suspension, 1.5%

DRUG

Vehicle

Vehicle

Sponsors & Collaborators

  • Oculis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2024-05-02
Completion
2024-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128369 on ClinicalTrials.gov