CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 199 enrolled
Drug / intervention
XEN® Gel Stent +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02006693
NCT02006693Phase 4Completed
CompareCT.gov

Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

AqueSys, Inc.·interventional·Posted Dec 10, 2013·Updated Apr 22, 2019

In Brief

A Phase 4 clinical trial evaluating XEN® Gel Stent and Cataract Surgery for Primary Open Angle Glaucoma. Completed, enrolled 199 participants across 21 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Open Angle Glaucoma
CountriesAustria, Belgium, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, Venezuela
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 10, 2013
Enrollment StartDec 5, 2013
Primary CompletionFeb 9, 2016
Study CompletionJan 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.6 years ago

Interventions

XEN® Gel Stentdevice

The XEN® Gel Stent (XEN45 implant) was placed in the study eye.

Cataract Surgeryprocedure

Participants diagnosed with a cataract elected to have cataract surgery.