A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Tear Run-in, licaminlimab, Vehicle of licaminlimab.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype
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.
Interventions
- 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. - Other Vehicle of licaminlimab
Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
Primary outcome measures
- 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 outcome measures (1)
- 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]
Eligibility criteria
Inclusion criteria
- Physician diagnosis of Dry Eye Disease in the past 6 months
- Use of over-the-counter tears
- Must agree to genotype testing
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- East West Eye Institute — Aliso Viejo
- Orange County Ophthalmology — Garden Grove
- Global Research Management — Glendale
- LoBue Laser and Eye Medical Center — Murrieta
- Eye Research Foundation — Newport Beach
- North Bay Eye Associates, Inc. — Petaluma
- Vision Institute — Colorado Springs
- Segal Drug Trials, Inc. — Delray Beach
- … and 6 more centers
Identifiers
NCT: NCT07548632 · LC-3301