A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
PREDICT-1
A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype
1 other identifier
interventional
160
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedStudy Start
First participant enrolled
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 5, 2026
May 1, 2026
8 months
April 16, 2026
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).
Day 1 to Day 29
Study Arms (2)
licaminlimab
EXPERIMENTAL60 mg/mL licaminlimab ophthalmic solution
Vehicle
PLACEBO COMPARATORVehicle of licaminlimab ophthalmic solution
Interventions
Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
Eligibility Criteria
You may qualify if:
- Physician diagnosis of Dry Eye Disease in the past 6 months
- Use of over-the-counter tears
- Must agree to genotype testing
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oculislead
Study Sites (10)
Global Research Management
Glendale, California, 91204, United States
Eye Research Foundation
Newport Beach, California, 92664, United States
Vision Institute
Colorado Springs, Colorado, 80907, United States
Segal Drug Trials, Inc.
Delray Beach, Florida, 33484, United States
Oculus Research, Inc.
Garner, North Carolina, 27529, United States
CORE, Inc
Shelby, North Carolina, 28150, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066, United States
Erie Retina Research
Erie, Pennsylvania, 16507, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Piedmont Eye Center, Inc.
Lynchburg, Virginia, 24502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Sponsor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 23, 2026
Study Start
April 16, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05