AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

May 30, 2017 updated by: AqueSys, Inc.

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma

To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • George R. Reiss, MD PC
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • Vold Vision
    • California
      • Montebello, California, United States, 90640
        • Montebello Eye Center
      • Oceanside, California, United States, 92056
        • San Diego Eye Care Center
      • Palo Alto, California, United States, 94306
        • Palo Alto Eye Group
    • Colorado
      • Fort Collins, Colorado, United States, 80525
        • Eye Center of Northern Colorado
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Stiles Eyecare Excellence & Glaucoma Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis, Department of Ophthalmology
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary
    • Texas
      • Dallas, Texas, United States, 75231
        • Glaucoma Associates of Texas
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Refractory Glaucoma
  • Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
  • Visual field mean deviation score of -3 dB or worse
  • Shaffer Angle Grade ≥ 3
  • Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria:

  • Active Neovascular Glaucoma
  • Previous glaucoma shunt/valve in the targeted quadrant
  • History of corneal surgery, opacities or disease/pathology
  • Anticipated need for ocular surgery
  • Non-study eye with BCVA of 20/200 or worse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AqueSys XEN 45 Glaucoma Implant
Device: AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
Time Frame: 12 Months
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.
12 Months
Mean Change in IOP From Baseline
Time Frame: 12 Months
Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AqueSys, Inc.

Collaborators

Allergan

Investigators

  • Study Chair: Richard A Lewis, M.D., Grutzmacher, Lewis & Sierra Surgical Eye Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (ESTIMATE)

January 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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