RecruitingPhase 2Phase 3NCT07548632

A Clinical Study Evaluating Licaminlimab for Dry Eye Disease

A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype


Sponsor

Oculis

Enrollment

160 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Physician diagnosis of Dry Eye Disease in the past 6 months
  • Use of over-the-counter tears
  • Must agree to genotype testing

Exclusion Criteria1

  • \- 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.

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Interventions

OTHERArtificial Tear Run-in

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

DRUGlicaminlimab

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

OTHERVehicle of licaminlimab

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


Locations(10)

Global Research Management

Glendale, California, United States

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Segal Drug Trials, Inc.

Delray Beach, Florida, United States

Oculus Research, Inc.

Garner, North Carolina, United States

CORE, Inc

Shelby, North Carolina, United States

Scott & Christie and Associates

Cranberry Township, Pennsylvania, United States

Erie Retina Research

Erie, Pennsylvania, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Piedmont Eye Center, Inc.

Lynchburg, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07548632


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