Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182358
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-12-13
Brief Title:
Impact of XDEMVY on Demodex Blepharitis in Soft Contact Lens Wearers
Sponsor:
Tarsus Pharmaceuticals Inc
Organization:
Tarsus Pharmaceuticals Inc
Study Overview
Official Title:
Randomized Controlled Trial to Evaluate the Impact of XDEMVY on Demodex Blepharitis in Soft Contact Lens Wearers
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ariel
Brief Summary:
To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience
Detailed Description:
This Phase 4 study is a prospective multicenter randomized vehicle-controlled double-masked two-arm parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers The primary outcome measure is the reduction of collarettes at Day 43 The secondary outcome measures are the reduction of eyelid margin erythema at Day 43 subject-reported comfortable contact lens daily wear time and total contact lens wear time Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None