A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype
Oculis
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- OtherArtificial Tear Run-in
Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
- Druglicaminlimab
Licaminlimab eye drops three times daily (TID) for 29 days.
- OtherVehicle of licaminlimab
Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
Locations (10)
- Global Research ManagementGlendale, California
- Eye Research FoundationNewport Beach, California
- Vision InstituteColorado Springs, Colorado
- Segal Drug Trials, Inc.Delray Beach, Florida
- Oculus Research, Inc.Garner, North Carolina
- CORE, IncShelby, North Carolina