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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

RELIEF Trial 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.Check my eligibility

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.See study design

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.

RELIEF Trial 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.

RELIEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 43

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease

RELIEF 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ORA, Inc.Industry Sponsor

69 Previous Clinical Trials

8,832 Total Patients Enrolled

OculisLead Sponsor

8 Previous Clinical Trials

1,610 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely is this medical experiment being conducted in the city?

"This trial is currently taking place in Colorado Springs, Shelby and Erie along with an additional 5 sites. To reduce travel constraints for potential participants, it would be advisable to select the most proximal location."

Answered by AI

Are any new participants still being accepted for the trial?

"Data sourced from clinicaltrials.gov reflects that this trial is not currently recruiting patients; the initial posting was on December 1st 2023 and the last update came eleven days later. Nonetheless, 133 other medical trials are actively enrolling participants right now."

Answered by AI

Is licaminlimab (OCS-02) considered a reliable option for patients?

"Licaminlimab (OCS-02) has been granted a score of 2 on our safety scale due to the existence of some data confirming its relative security, though there have yet to be studies that validate its efficacy."

Answered by AI