Overview
Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Dry Eye Disease
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2024-12-01
2024-12-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
OculisCollaborator:
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.