Study Evaluating Different Doses of Cevimeline Ophthalmic Solution Compared to Placebo for Dry Eye Disease A Phase 2, Randomized, Double-Masked Trial to Assess Safety and Efficacy

What this Trial Is About

Researchers are conducting a Phase 2, randomized, double-masked, vehicle-controlled study to evaluate how well different doses of Cevimeline Ophthalmic Solution work and how safe and tolerable they are compared to a placebo in people with Dry Eye Disease (DED). The study focuses on adults who have moderate to severe DED, either diagnosed clinically or reported by themselves for at least six months. The goal is to understand the treatment effects of Cevimeline on this eye condition. During the study, about 120 participants will first undergo a 14-day period where they use a placebo eye drop twice daily to establish a baseline. After this run-in period, eligible participants will be randomly assigned to one of four groups receiving different treatments: low dose (1%), mid dose (2%), or high dose (4%) of Cevimeline Ophthalmic Solution, or a placebo. Participants will continue to self-administer one drop in each eye twice daily, morning and evening with at least six hours between doses. Study visits are scheduled on Day 1 (baseline), Day 15, Day 29, Day 57, and Day 85 to monitor progress. Participants will be assessed through eye exams including a Schirmer test on Day 85 to measure tear production. They will also have their vision checked and report symptoms during visits. The study requires participants to stop using other eye medications except the study drops and to avoid contact lens use during the trial. Safety and effectiveness will be closely monitored throughout the study period, which lasts approximately 85 days from baseline.

Evaluation of BTV100 in Subjects With Dry Eye Disease