NCT06543303

Evaluation of BTV100 in Subjects With Dry Eye Disease

A Phase 2, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Efficacy and Safety of Cevimeline Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: BioTheraVision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

Detailed description

At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study. At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle. Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	BTV100 Low dose	1% Cevimeline Ophthalmic Solution
DRUG	BTV100 Mid dose	2% Cevimeline Ophthalmic Solution
DRUG	BTV100 High dose	4% Cevimeline Ophthalmic Solution
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-02-15
• Completion: 2026-02-15
• First posted: 2024-08-09
• Last updated: 2025-01-22

Locations

6 sites across 2 countries: Australia, Taiwan

Regulatory

• FDA-regulated drug study