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

Oculis

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: licaminlimab; Other: vehicle of OCS-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT05896670

LC-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

licaminlimab (OCS-02)

Experimental group

Description:

60 mg/mL licaminlimab ophthalmic solution

Treatment:

Drug: licaminlimab

Vehicle

Placebo Comparator group

Description:

Vehicle of licaminlimab (OCS-02) ophthalmic solution

Treatment:

Other: vehicle of OCS-02