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

Dry Eye Disease Clinical Trial

— RELIEF  

Official title:

A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05896670
• Other study ID #: LC-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 29, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Oculis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 2b, multicenter, randomized, double-masked, active-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• licaminlimab
ophthalmic suspension 60 mg/mL Subjects will receive licaminlimab eye drops TID for 6 weeks. All subjects will be assigned artificial tears TID for 2 weeks.

Other:
• vehicle of OCS-02
inert ophthalmic suspension vehicle of OCS-02 Subjects will receive vehicle eye drops TID for 6 weeks. All subjects will be assigned artificial tears TID for 2 weeks.

Locations

Country	Name	City	State
United States	Oculis Investigative Site	Colorado Springs	Colorado
United States	Oculis Investigative Site	Erie	Pennsylvania
United States	Oculis Investigative Site	Memphis	Tennessee
United States	Oculis Investigative Site	Newport Beach	California
United States	Oculis Investigative Site	Shelby	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Oculis	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease	Total corneal staining - change from baseline versus vehicle pre-CAE®, pre-CAE® to post-CAE®, and post-CAE®	Baseline to Day 43