A Clinical Study Evaluating Licaminlimab for Dry Eye Disease (PREDICT-1)

May 1, 2026 updated by: Oculis

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oculis Chief Development Officer
  • Phone Number: 617 928 5886
  • Email: info@oculis.com

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91204
        • Recruiting
        • Global Research Management
      • Newport Beach, California, United States, 92664
        • Recruiting
        • Eye Research Foundation
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Vision Institute
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Not yet recruiting
        • Segal Drug Trials, Inc.
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Recruiting
        • Oculus Research, Inc.
      • Shelby, North Carolina, United States, 28150
        • Not yet recruiting
        • CORE, Inc
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Recruiting
        • Scott & Christie and Associates
      • Erie, Pennsylvania, United States, 16507
        • Not yet recruiting
        • Erie Retina Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Total Eye Care, PA
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Piedmont Eye Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: licaminlimab
60 mg/mL licaminlimab ophthalmic solution
Other: Artificial Tear Run-in
Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
Drug: licaminlimab
Licaminlimab eye drops three times daily (TID) for 29 days.
Placebo Comparator: Vehicle
Vehicle of licaminlimab ophthalmic solution
Other: Artificial Tear Run-in
Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
Other: Vehicle of licaminlimab
Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From Day 1 to Day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-3301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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