A Phase 2 interventional study of licaminlimab and vehicle of OCS-02 in Dry Eye Disease, sponsored by Oculis. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Oculis · Phase 2, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 122 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Oculis is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.
60 mg/mL licaminlimab ophthalmic solution
Drug: licaminlimab · Other: Artificial tears
Vehicle of licaminlimab (OCS-02) ophthalmic solution
Other: vehicle of OCS-02 · Other: Artificial tears
ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.
Also known as: 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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Oculis