Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543303
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Evaluation of BTV100 in Subjects With Dry Eye Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 visitVisit 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 visitVisit 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 BaselineVisit 2 Day 1 subjects who continue fulfilling inclusionexclusion 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
At BaselineVisit 2 Day 1 subjects who continue fulfilling inclusionexclusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None