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Active, not recruiting Phase 2/3

A Clinical Study Evaluating Licaminlimab for Dry Eye Disease

NCT07548632 · tracked via the Priya Life Science USA tracker
Sponsor
Oculis
Phase
Phase 2/3
Started
2026-04-16
Last updated
2026-10-27

Condition(s) studied

Dry Eye Disease (DED)

Investigational drug(s) / intervention(s)

Artificial Tear Run-inlicaminlimabVehicle of licaminlimab

Artificial Tear Run-in: Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.

licaminlimab: Licaminlimab eye drops three times daily (TID) for 29 days.

Vehicle of licaminlimab: Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.

Study summary

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry Eye Disease and a specific genotype.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Physician diagnosis of Dry Eye Disease in the past 6 months * Use of over-the-counter tears * Must agree to genotype testing Key Exclusion Criteria: \- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety.

Primary outcome measure(s)

  • Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype — From Day 1 to Day 29

Trial sites (14)

FacilityCityRegionStatus
East West Eye Institute Aliso Viejo California
Orange County Ophthalmology Garden Grove California
Global Research Management Glendale California
LoBue Laser and Eye Medical Center Murrieta California
Eye Research Foundation Newport Beach California
North Bay Eye Associates, Inc. Petaluma California
Vision Institute Colorado Springs Colorado
Segal Drug Trials, Inc. Delray Beach Florida
Oculus Research, Inc. Garner North Carolina
CORE, Inc Shelby North Carolina
Scott & Christie and Associates Cranberry Township Pennsylvania
Erie Retina Research Erie Pennsylvania
Total Eye Care, PA Memphis Tennessee
Piedmont Eye Center, Inc. Lynchburg Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07548632 on ClinicalTrials.gov ↗ ← All trials in the USA