Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544694
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
A Study to Investigate the Effect of 0003 AR-15512 on Subjects With Dry Eye Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3b Study to Investigate the Effect of 0003 AR-15512 on the Ocular Surface Characteristics of Subjects With Dry Eye Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0003 0003 AR-15512 on ocular surface characteristics of subjects with dry eye disease DED
Detailed Description:
Qualified subjects will enter a 14-day run-in period followed by a 13-week randomized treatment period for a total individual duration of participation of approximately 15 weeks During the run-in period subjects will administer Artificial Tears REFRESH Classic as one drop in each eye twice daily
This is a Phase 3b study
This is a Phase 3b study
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