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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.
inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks.
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.
Oculis Investigative Site
Newport Beach, California, United States
Oculis Investigative Site
Colorado Springs, Colorado, United States
Oculis Investigative Site
Shelby, North Carolina, United States
Oculis Investigative Site
Erie, Pennsylvania, United States
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study
Time frame: Baseline to Day 43
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Oculis Investigative Site
Memphis, Tennessee, United States