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Evaluation of BTV100 in Subjects With Dry Eye Disease
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).
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-11-15
Primary completion: 2026-02-15
Study completion finish: 2026-02-15
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06543303
Intervention or treatment
DRUG: BTV100 Low dose
DRUG: BTV100 Mid dose
DRUG: BTV100 High dose
DRUG: Placebo
Conditions
- • Dry Eye
Find a site
Closest Location:
Sydney Eye Hospital
Research sites nearby
Select from list below to view details:
Sydney Eye Hospital
Sydney, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: BTV100 Low dose
| DRUG: BTV100 Low dose
|
EXPERIMENTAL: BTV100 Mid dose
| DRUG: BTV100 Mid dose
|
EXPERIMENTAL: BTV High dose
| DRUG: BTV100 High dose
|
PLACEBO_COMPARATOR: Vehicle
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Schirmer test | Change from baseline in unanesthetized Schirmer test of study eye | Day 85 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Schirmer test | Proportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eye | Day 15, 29, 57 and 85. |
Frequently Asked Questions
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