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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2024-03-27

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

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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licaminlimab (OCS-02)

60 mg/mL licaminlimab ophthalmic solution

Group Type EXPERIMENTAL

licaminlimab

Intervention Type DRUG

ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.

Artificial tears

Intervention Type 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.

Vehicle

Vehicle of licaminlimab (OCS-02) ophthalmic solution

Group Type PLACEBO_COMPARATOR

vehicle of OCS-02

Intervention Type 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

Intervention Type 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.

Interventions

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licaminlimab

ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.

Intervention Type DRUG

vehicle of OCS-02

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

Intervention Type OTHER

Artificial tears

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.

Intervention Type OTHER

Other Intervention Names

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OCS-02

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No