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Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

NCT02006693 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2019-04-22

Study results available
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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.

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

XEN® Gel Stent

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

PROCEDURE

Cataract Surgery

Participants diagnosed with a cataract elected to have cataract surgery.

Sponsors & Collaborators

  • AqueSys, Inc.

    lead INDUSTRY

Principal Investigators

  • Vanessa Vera, MD · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-05
Primary Completion
2016-02-09
Completion
2017-01-26

Countries

  • Austria
  • Belgium
  • Germany
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom
  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006693 on ClinicalTrials.gov