Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Dry Eye Disease

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic suspension is more effective than vehicle in treating signs of dry eye disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Be at least 18 years of age.

• Provide written informed consent.

• Be willing and able to comply with all study procedures.

• Have a history of dry eye disease for at least 6 months prior to Visit 1.

Exclusion Criteria:

• Have any clinically significant slit-lamp findings at least one eye at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters.

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation in at least one eye at Visit 1 or Visit 2.

• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.

• Additional inclusion/exclusion criteria apply.