Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400459
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-05-01
Brief Title:
IVW-1001 Phase 12 in Subjects With Dry Eye Disease
Sponsor:
IVIEW Therapeutics Inc
Organization:
IVIEW Therapeutics Inc
Study Overview
Official Title:
Phase 12a Proof-of-Concept Multicenter Parallel Vehicle-Controlled Double-Masked Randomized Study Evaluating the Safety Tolerability and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
Double-masked dose-response trial of IVW-1001 in subjects with dry eye disease
Detailed Description:
This is a randomized 111 multicenter parallel vehicle-controlled double-masked study to evaluate the safety tolerability and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 02 high dose IVW 1001 01 low dose or IVW-1001 Ophthalmic Eyelid Wipe Placebo vehicle Subjects will participate in a 7-day run-in period followed by a 28-daydosing period
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?:
None
Is an FDA AA801 Violation?:
None