A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Oculis
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
Study Overview
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 solution is more effective than vehicle in treating signs of dry eye disease.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
licaminlimab (OCS-02)
60 mg/mL licaminlimab ophthalmic solution
Intervention: licaminlimab (Drug)
licaminlimab (OCS-02)
60 mg/mL licaminlimab ophthalmic solution
Intervention: Artificial tears (Other)
Vehicle
Vehicle of licaminlimab (OCS-02) ophthalmic solution
Intervention: vehicle of OCS-02 (Other)
Vehicle
Vehicle of licaminlimab (OCS-02) ophthalmic solution
Intervention: Artificial tears (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported