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

February 2, 2024 updated by: Oculis

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

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oculis Study Leader
  • Phone Number: +41 21 711 3970
  • Email: info@oculis.com

Study Contact Backup

  • Name: Ora, Inc. Study Leader
  • Phone Number: +1-978-685-8900

Study Locations

    • California
      • Newport Beach, California, United States, 92663
        • Oculis Investigative Site
        • Contact:
          • Oculis Investigator
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: licaminlimab (OCS-02)
60 mg/mL licaminlimab ophthalmic suspension
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 Names:
  • OCS-02
Placebo Comparator: Vehicle
Vehicle of licaminlimab (OCS-02) ophthalmic suspension
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.

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
Time Frame: Baseline to Day 43
Total corneal staining - change from baseline versus vehicle pre-CAE®, pre-CAE® to post-CAE®, and post-CAE®
Baseline to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 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)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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