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

2026-08-28

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

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)

Facility	City	Region	Status
East West Eye Institute	Aliso Viejo	California	Recruiting
Orange County Ophthalmology	Garden Grove	California	Recruiting
Global Research Management	Glendale	California	Recruiting
LoBue Laser and Eye Medical Center	Murrieta	California	Recruiting
Eye Research Foundation	Newport Beach	California	Recruiting
North Bay Eye Associates, Inc.	Petaluma	California	Recruiting
Vision Institute	Colorado Springs	Colorado	Recruiting
Segal Drug Trials, Inc.	Delray Beach	Florida	Active Not Recruiting
Oculus Research, Inc.	Garner	North Carolina	Recruiting
CORE, Inc	Shelby	North Carolina	Recruiting
Scott & Christie and Associates	Cranberry Township	Pennsylvania	Active Not Recruiting
Erie Retina Research	Erie	Pennsylvania	Recruiting
Total Eye Care, PA	Memphis	Tennessee	Recruiting
Piedmont Eye Center, Inc.	Lynchburg	Virginia	Recruiting

More Oculis trials in the USA

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research Recruiting

Other trials for the same condition

Randomized Single Center Study to Evaluate Tolerability, Symptoms, and Visual Functional Outcomes With the Use of OTC Lubricating Eye Drops in Subjects With Dry Eye Disease Recruiting

An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease Recruiting

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