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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT03362931
Collaborator
(none)
65
Enrollment
16
Locations
1
Arm
44
Actual Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

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:
Interventional
Actual Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03362931
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:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure

Study Results

No Results Posted as of Apr 7, 2022