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Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery

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

Last updated 2024-12-10

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.

Conditions

  • Inflammation Eye
  • Pain, Postoperative
  • Cataract

Interventions

DRUG

Dexamethasone Ophthalmic Suspension

Ophthalmic Suspension,1.5% \[15 mg/mL\] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

OTHER

Vehicle of OCS-01

inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • 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