Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma

Allergan (Industry)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: XEN45
Phase 3

Study Design

Study Type:
Actual Enrollment :
65 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Actual Study Start Date :
Jul 19, 2018
Actual Primary Completion Date :
Mar 18, 2022
Actual Study Completion Date :
Mar 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: XEN45 Glaucoma Treatment System (hereafter referred to as XEN)

XEN45 unilaterally implanted in the study eye

Device: XEN45
XEN45 unilaterally implanted in the study eye

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients achieving at least a 20% reduction from baseline Hour 0 IOP while on the same number or fewer IOP lowering medications [Baseline to Month 12]

    IOP will be measured using a Goldmann applanation tonometer

Secondary Outcome Measures

  1. Change from baseline the number of concomitant IOP-lowering medications [Baseline to Month 12]

    The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye

  • Study eye has healthy, free, and mobile conjunctiva in the target quadrant

Exclusion Criteria:
  • Uncontrolled systemic disease (eg, diabetes, hypertension)

  • Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day)

  • History of dermatologic keloid formation

  • Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye

  • History of following surgeries in the study eye:

  • incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions

  • corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty

  • previous laser or incisional intraocular surgery that might interfere with the outcome of this trial

  • Previous glaucoma shunt implantation in the target quadrant in the study eye

  • Active or history of chronic uveitis in the study eye

  • Unable to discontinue contact lens wear in the study eye during the study

Contacts and Locations


Site City State Country Postal Code
1 Marsden Eye Specialists Parramatta /ID# 232761 Paramatta New South Wales Australia 2150
2 Melbourne Eye Specialists /ID# 232767 Fitzroy Victoria Australia VIC3065
3 Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765 Vermont South Victoria Australia 3133
4 Institut de loeil des Laurentides /ID# 232780 Boisbriand Quebec Canada J7H 0E8
5 Ophthalmology Clinic Bellevue /ID# 232782 Montreal Quebec Canada H1V 1G5
6 Prism Eye Institute /ID# 232917 Mississauga Canada L5L 1W8
7 Seoul National University Hospital /ID# 233099 Seoul Korea, Republic of 03080
8 Nuh Medical Centre /ID# 232905 Singapore Singapore 119082
9 Tan Tock Seng Hospital /ID# 233014 Singapore Singapore 308433
10 Taipei Veterans General Hospital /ID# 232948 Taipei City Taipei Taiwan 11217
11 Buddhist Tzu Chi General Hospital /ID# 232664 Hualien Taiwan 97002
12 Royal Surrey County Hospital /ID# 233028 Guildford England United Kingdom GU2 7XX
13 Manchester University NHS Foundation Trust /ID# 232808 Manchester Lancashire United Kingdom M13 9WL
14 Queen Victoria Hospital /ID# 232812 East Grinstead West Sussex United Kingdom RH19 3DZ
15 East Suffolk and North Essex NHS Foundation Trust /ID# 232804 Colchester United Kingdom CO4 5JL
16 NHS Lothian /ID# 233052 Edinburgh United Kingdom EH3 9HE

Sponsors and Collaborators

  • Allergan


  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Allergan Identifier:
Other Study ID Numbers:
  • 1924-701-007
First Posted:
Dec 5, 2017
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022