Dry Eye
Conditions
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 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).
Interventions
DRUGBTV100 Low dose
1% Cevimeline Ophthalmic Solution
DRUGBTV100 Mid dose
2% Cevimeline Ophthalmic Solution
DRUGBTV100 High dose
4% Cevimeline Ophthalmic Solution
DRUGPlacebo
Placebo
Sponsors
BioTheraVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-masked investigational product.
Intervention model description
Double-masked, randomized, parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older (regardless of gender). 2. Provide written informed consent. 3. Willing and able to follow instructions and be available for required study visits during the study. 4. Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes. 5. 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 criteria
1. Known hypersensitivity or contraindication to the study drug or its components. 2. 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) 3. Current use of contact lenses or anticipated use during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer test | Day 85 | Change from baseline in unanesthetized Schirmer test of study eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer test | Day 15, 29, 57 and 85. | Proportion of subjects with an increase in unanesthetized Schirmer of 10 mm or more for study eye |
Countries
Australia, Taiwan
Contacts
Primary ContactMulan Lee, PhD
Outcome results
None listed