Overview

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.