Dry Eye Disease
Conditions
Keywords
Ophthalmology, Topical Ophthalmic Solution, Eye Drop, DED
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.
Interventions
DRUGlicaminlimab
ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.
OTHERvehicle 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.
OTHERArtificial 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.
Sponsors
ORA, Inc.
Oculis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease | Baseline to Day 43 | Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study |
Countries
United States
Outcome results
None listed