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Monoclonal Antibodies

Licaminlimab for Dry Eye Syndrome (RELIEF Trial)

Phase 2
Waitlist Available
Research Sponsored by Oculis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a history of dry eye disease in both eyes for at least 6 months prior to Visit 1.
Have a corneal fluorescein staining score of ≥ 2 in at least one region in one eye at Visits 1 and 2 and a central corneal staining score ≥ 1 in the same eye.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 43
Awards & highlights

Summary

This trial will study if licaminlimab can treat dry eye disease better than currently available treatments. #medtrial #dryeyedisease

Who is the study for?
This trial is for adults over 18 with dry eye disease lasting at least 6 months, who regularly use artificial tears and have certain scores on eye tests (Schirmer's Test, corneal staining, conjunctival redness). Participants must see well enough (20/100 vision or better) and agree to follow the study rules.
What is being tested?
The trial is testing licaminlimab ophthalmic suspension against a placebo (vehicle of OCS-02) to see if it's more effective in treating signs of dry eye disease. It will compare improvements between the two treatments.
What are the potential side effects?
Potential side effects are not explicitly listed here but may include typical reactions related to ophthalmic suspensions such as eye irritation, discomfort, redness, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had dry eye disease in both eyes for at least 6 months.
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I have moderate to severe eye surface damage confirmed by tests.
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I am 18 years old or older.
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I have reported moderate to severe dry eye symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: licaminlimab (OCS-02)Experimental Treatment1 Intervention
60 mg/mL licaminlimab ophthalmic suspension
Group II: VehiclePlacebo Group1 Intervention
Vehicle of licaminlimab (OCS-02) ophthalmic suspension

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Who is running the clinical trial?

ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,839 Total Patients Enrolled
OculisLead Sponsor
8 Previous Clinical Trials
1,610 Total Patients Enrolled
~69 spots leftby Sep 2025
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