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

What this Trial Is About

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease (DED) who have a specific TNFR1 genotype. This study aims to understand if licaminlimab can reduce the discomfort caused by DED. It is a Phase 2b/3, randomized, double-masked, and vehicle-controlled clinical trial conducted at multiple centers. Participants first use artificial tear eye drops three times daily for about 14 days as a run-in period. After this, they are randomly assigned to receive either licaminlimab ophthalmic solution or a placebo vehicle, both administered three times daily for 29 days. Licaminlimab is given as a 60 mg/mL eye drop solution, and the study compares its effects to the inactive vehicle solution. During the study, participants will have their ocular discomfort severity measured from the start to Day 29 to assess treatment impact, especially focusing on those with the specific genotype. Researchers will monitor safety and efficacy throughout. The study includes genotype testing and requires participants to have a recent physician diagnosis of Dry Eye Disease. The total participation involves initial run-in treatment followed by the randomized treatment period, with evaluations to capture symptom changes and safety.

A Clinical Study Evaluating Licaminlimab for Dry Eye Disease