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

Phase 2

Active, not recruiting

• Conditions: Dry Eye Disease
• Interventions: Drug: licaminlimab; Other: vehicle of OCS-02

• Registration Number: NCT05896670
• Lead Sponsor: Oculis

Brief 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.

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 Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Study Start: 2023-11-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
licaminlimab (OCS-02)	licaminlimab	60 mg/mL licaminlimab ophthalmic suspension
Vehicle	vehicle of OCS-02	Vehicle of licaminlimab (OCS-02) ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease	Baseline to Day 43	Total corneal staining - change from baseline versus vehicle pre-CAE®, pre-CAE® to post-CAE®, and post-CAE®

Trial Locations

Locations (1)

Oculis Investigative Site; 🇺🇸 Memphis, Tennessee, United States