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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: licaminlimab
* Other: vehicle of OCS-02


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: licaminlimab (OCS-02)<br>60 mg/mL licaminlimab ophthalmic suspension | Drug: licaminlimab<br>* 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.<br>* Other names: OCS-02;|
| Placebo Comparator: Vehicle<br>Vehicle of licaminlimab (OCS-02) ophthalmic suspension | Other: vehicle of OCS-02<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DED, Ophthalmology, Topical Ophthalmic Suspension, Eye Drop