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Completed

NCT Number: NCT05896670

Safety and Efficacy of Licaminlimab Ophthalmic Solution 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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oculis Investigative Site, Newport Beach, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

licaminlimab

Drug

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

vehicle of OCS-02

Other

inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks.

Artificial tears

Other

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.

Primary outcomes

  1. To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease

    Time frame: Baseline to Day 43

    Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study

Sponsors and collaborators

Lead sponsor

Oculis

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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