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
BioTheraVision, Inc.
120 participants
Dec 31, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 18 years of age or older (regardless of gender).
- Provide written informed consent.
- Willing and able to follow instructions and be available for required study visits during the study.
- Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
- Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2:
Exclusion Criteria3
- Known hypersensitivity or contraindication to the study drug or its components.
- Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)
- Current use of contact lenses or anticipated use during the study.
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Interventions
1% Cevimeline Ophthalmic Solution
2% Cevimeline Ophthalmic Solution
4% Cevimeline Ophthalmic Solution
Placebo
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06543303