Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400589
Status:
SUSPENDED
Last Update Posted:
2024-05-31
First Post:
2024-04-29
Brief Title:
A Study to Evaluate the Efficacy and Safety of Tanfanercept HL036 in Dry Eye Disease
Sponsor:
HanAll BioPharma Co Ltd
Organization:
HanAll BioPharma Co Ltd
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept HL036 Ophthalmic Solution 025 and 10 Compared to Vehicle in Participants With Dry Eye Disease VELOS-4
Status:
SUSPENDED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Logistical issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VELOS-4
Brief Summary:
The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 025 and 10 to vehicle for the treatment of DED
Detailed Description:
The purpose of this research study is to test the safety and effectiveness how well the drug works of Tanfanercept ophthalmic solution 025 and Tanfanercept ophthalmic solution 1 against vehicle no active treatment Effectiveness will be measured by the improvement in Schirmer Test results a test to see how many tears you produce reduction of dry eye symptoms eye redness conjunctival redness and eye surface irritation corneal staining conjunctival staining Eye safety assessments will also be performed
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