Recruiting
Phase 2
Phase 3

Licaminlimab

Sponsor:

Oculis

Code:

NCT07548632

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artificial Tear Run-in

licaminlimab

Vehicle of licaminlimab

Study Details

Brief 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.

Conditions

Dry Eye Disease (DED)

Study ID

NCT07548632

Start date

Apr 16, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: licaminlimab

60 mg/mL licaminlimab ophthalmic solution

placebo comparator: Vehicle

Vehicle of licaminlimab ophthalmic solution

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Oculis Chief Development Officer

617 928 5886info@oculis.com

Locations

East West Eye Institute

Recruiting

Aliso Viejo, California, United States, 92656

Orange County Ophthalmology

Recruiting

Garden Grove, California, United States, 92843

Global Research Management

Recruiting

Glendale, California, United States, 91204

LoBue Laser and Eye Medical Center

Recruiting

Murrieta, California, United States, 92562

Eye Research Foundation

Recruiting

Newport Beach, California, United States, 92664

North Bay Eye Associates, Inc.

Recruiting

Petaluma, California, United States, 94954

Vision Institute

Recruiting

Colorado Springs, Colorado, United States, 80907

Oculus Research, Inc.

Recruiting

Garner, North Carolina, United States, 27529

CORE, Inc

Recruiting

Shelby, North Carolina, United States, 28150

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16507

Total Eye Care, PA

Recruiting

Memphis, Tennessee, United States, 38119

Piedmont Eye Center, Inc.

Recruiting

Lynchburg, Virginia, United States, 24502

More Information

Sponsor

Oculis

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • licaminlimab
  • OCS-02
  • PREDICT-1
  • genotype based development
  • Eye drops

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oculis on 2026-08-28.