Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease (RELIEF)

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

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 solution is more effective than vehicle in treating signs of dry eye disease.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: licaminlimab; Other: Artificial tears; Other: vehicle of OCS-02

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Oculis Investigative Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Oculis Investigative Site
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Oculis Investigative Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Oculis Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Oculis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: licaminlimab (OCS-02); 60 mg/mL licaminlimab ophthalmic solution	Drug: licaminlimab; ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.; Other Names: OCS-02; Other: Artificial tears; Subjects who quality after an initial screening were entered into a run-in phase where they received artificial tears to use three times daily (TID) for approximately 14 days.
Placebo Comparator: Vehicle; Vehicle of licaminlimab (OCS-02) ophthalmic solution	Other: Artificial tears; Subjects who quality after an initial screening were entered into a run-in phase where they received artificial tears to use three times daily (TID) for approximately 14 days.; Other: vehicle of OCS-02; inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease	Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study	Baseline to Day 43

Collaborators and Investigators

• Sponsor: Oculis
• Collaborators: ORA, Inc.
• Investigators: Study Director: Sharon Klier, MD, MPH, Oculis

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: DED; Ophthalmology; Eye Drop; Topical Ophthalmic Solution
• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions; Lubricant Eye Drops
• Other Study ID Numbers: LC-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No