Phase 2 Study of Cevimeline Eye Drops for Treating Dry Eye Disease Compared to Placebo

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and tolerability of repeated doses of Cevimeline Ophthalmic Solution compared to a placebo vehicle in adults with Dry Eye Disease DED. This Phase 2, randomized, double-masked, vehicle-controlled study aims to better understand treatment options for individuals with moderate to severe DED, a condition causing eye discomfort and dryness. Participants will begin with a 14-day run-in period where they self-administer one drop of the placebo vehicle to each eye twice daily. After this, eligible subjects will be randomly assigned to one of four groups to receive either 1%, 2%, or 4% Cevimeline Ophthalmic Solution or the vehicle. They will continue self-administering the assigned treatment twice daily and attend clinic visits on Days 15, 29, 57, and 85 for evaluations. Throughout the study, participants will undergo assessments including the Schirmer test to measure tear production at various points, particularly on Day 85 as the primary outcome. Safety and tolerability will also be monitored during clinic visits. The total study period spans approximately 85 days, with detailed follow-ups to observe treatment effects and any side effects under medical supervision.

Evaluation of BTV100 in Subjects With Dry Eye Disease