Actively Recruiting
Evaluation of BTV100 in Subjects With Dry Eye Disease
Led by BioTheraVision, Inc. · Updated on 2025-01-22
120
Participants Needed
6
Research Sites
58 weeks
Total Duration
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AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of BTV100 in Subjects With Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older regardless of gender
- Provide written informed consent
- Willing and able to follow instructions and attend all study visits
- Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes
- Have moderate to severe Dry Eye Disease diagnosed clinically or by self-report for at least 6 months
- Meet specific clinical criteria for Dry Eye Disease in at least one eye at screening and baseline visits
You will not qualify if you...
- Known allergy or contraindication to the study drug or its ingredients
- Use of topical ophthalmic, dermatologic, or systemic calcineurin inhibitors (e.g., cyclosporine, tacrolimus) within 28 days before screening
- Current use or planned use of contact lenses during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cataract and Eye Surgery Centre, Victoria
Doncaster East, Victoria, Australia
Actively Recruiting
2
Sydney Eye Hospital
Sydney, Australia
Actively Recruiting
3
Chang Gung Memorial Hospital-Kaohsiung Branch
Kaohsiung City, Taiwan
Actively Recruiting
4
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
6
Chang Gung Memorial Hospital-LinKou Branch
Taoyuan, Taiwan
Actively Recruiting
Research Team
M
Mulan Lee, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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