Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT02006693
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2013-12-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Sponsor:
AqueSys, Inc.
Organization:
Study Overview
Official Title:
Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
Status:
COMPLETED
Status Verified Date:
2019-01
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:
The objective of this study was to evaluate the AqueSys XEN Implant \[XEN® Gel Stent (XEN45 Implant)\] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: