A Clinical Study Evaluating Licaminlimab for Dry Eye Disease

Phase 3RecruitingNCT07548632

Oculis160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Dry Eye Disease (DED)

Interventions

Artificial Tear Run-inOTHER

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

licaminlimabDRUG

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

Vehicle of licaminlimabOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

East West Eye Institute

Aliso Viejo, California, United States

RECRUITING

Orange County Ophthalmology

Garden Grove, California, United States

Outcomes

Primary Outcomes

Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype

Time frame: From Day 1 to Day 29

Secondary Outcomes

Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).

Time frame: Day 1 to Day 29

Central Contacts

Oculis Chief Development Officer

CONTACT

617 928 5886 info@oculis.com

Data from ClinicalTrials.gov

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