Status:
RECRUITING
Evaluation of BTV100 in Subjects With Dry Eye Disease
Lead Sponsor:
BioTheraVision, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Solu...
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-administ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06543303
Start Date
December 31 2024
End Date
February 15 2026
Last Update
January 22 2025
Active Locations (6)
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1
Cataract and Eye Surgery Centre, Victoria
Doncaster East, Victoria, Australia
2
Sydney Eye Hospital
Sydney, Australia
3
Chang Gung Memorial Hospital-Kaohsiung Branch
Kaohsiung City, Taiwan
4
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan