Viewing Study NCT06543303



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

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