NCT03362931

Brief Summary

This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2018

Typical duration for phase_3

Geographic Reach
6 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

July 19, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

April 1, 2023

Enrollment Period

3.7 years

First QC Date

November 30, 2017

Results QC Date

March 7, 2023

Last Update Submit

April 24, 2023

Conditions

GlaucomaAngle-Closure

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12

    IOP will be measured using a Goldmann applanation tonometer

    Month 12

Secondary Outcomes (1)

  • Change From Baseline the Number of Concomitant IOP-lowering Medications

    Month 12

Study Arms (1)

XEN45 Glaucoma Treatment System (hereafter referred to as XEN)

EXPERIMENTAL

XEN45 unilaterally implanted in the study eye

Device: XEN45

Interventions

XEN45DEVICE

XEN45 unilaterally implanted in the study eye

XEN45 Glaucoma Treatment System (hereafter referred to as XEN)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Marsden Eye Specialists Parramatta /ID# 232761

Paramatta, New South Wales, 2150, Australia

Location

Melbourne Eye Specialists /ID# 232767

Fitzroy, Victoria, VIC3065, Australia

Location

Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765

Vermont South, Victoria, 3133, Australia

Location

Institut de loeil des Laurentides /ID# 232780

Boisbriand, Quebec, J7H 0E8, Canada

Location

Ophthalmology Clinic Bellevue /ID# 232782

Montreal, Quebec, H1V 1G5, Canada

Location

Prism Eye Institute /ID# 232917

Mississauga, L5L 1W8, Canada

Location

Nuh Medical Centre /ID# 232905

Singapore, 119082, Singapore

Location

Tan Tock Seng Hospital /ID# 233014

Singapore, 308433, Singapore

Location

Seoul National University Hospital /ID# 233099

Seoul, 03080, South Korea

Location

Buddhist Tzu Chi General Hospital /ID# 232664

Hualien City, Hualien, 97002, Taiwan

Location

Taipei Veterans General Hospital /ID# 232948

Taipei City, Taipei, 11217, Taiwan

Location

Royal Surrey County Hospital /ID# 233028

Guildford, England, GU2 7XX, United Kingdom

Location

Manchester University NHS Foundation Trust /ID# 232808

Manchester, Lancashire, M13 9WL, United Kingdom

Location

Queen Victoria Hospital /ID# 232812

East Grinstead, West Sussex, RH19 3DZ, United Kingdom

Location

East Suffolk and North Essex NHS Foundation Trust /ID# 232804

Colchester, CO4 5JL, United Kingdom

Location

NHS Lothian /ID# 233052

Edinburgh, EH3 9HE, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • ALLERGAN INC.

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 5, 2017

Study Start

July 19, 2018

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

May 17, 2023

Results First Posted

May 17, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For details on when studies are available for sharing, please refer to the link below
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
More information

Locations

AU(3)CA(3)TW(2)GB(5)KR(1)SG(2)