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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oculis
• Collaborator: ORA, Inc.
• Treatments: Dexamethasone

Criteria

Inclusion Criteria (Selection):

• Provide written informed consent, approved by the appropriate ethics committee;

• Able to comply with the study requirements and visit schedule;

• At least 18 years of age of either sex or any race;

• Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;

• Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours post- uncomplicated cataract surgery without vitreous loss]);

Exclusion Criteria:

• Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;

• Have only one functional eye (monocular);

• 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;

• Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye *Additional inclusion/exclusion criteria apply