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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362931
• Other study ID #: 1924-701-007
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2018
• Est. completion date: March 18, 2022

Study information

• Verified date: April 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Device:
• XEN45
XEN45 unilaterally implanted in the study eye

Locations

Country	Name	City	State
Australia	Melbourne Eye Specialists /ID# 232767	Fitzroy	Victoria
Australia	Marsden Eye Specialists Parramatta /ID# 232761	Paramatta	New South Wales
Australia	Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765	Vermont South	Victoria
Canada	Institut de loeil des Laurentides /ID# 232780	Boisbriand	Quebec
Canada	Prism Eye Institute /ID# 232917	Mississauga
Canada	Ophthalmology Clinic Bellevue /ID# 232782	Montreal	Quebec
Korea, Republic of	Seoul National University Hospital /ID# 233099	Seoul
Singapore	Nuh Medical Centre /ID# 232905	Singapore
Singapore	Tan Tock Seng Hospital /ID# 233014	Singapore
Taiwan	Buddhist Tzu Chi General Hospital /ID# 232664	Hualien
Taiwan	Taipei Veterans General Hospital /ID# 232948	Taipei City	Taipei
United Kingdom	East Suffolk and North Essex NHS Foundation Trust /ID# 232804	Colchester
United Kingdom	Queen Victoria Hospital /ID# 232812	East Grinstead	West Sussex
United Kingdom	NHS Lothian /ID# 233052	Edinburgh
United Kingdom	Royal Surrey County Hospital /ID# 233028	Guildford	England
United Kingdom	Manchester University NHS Foundation Trust /ID# 232808	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Australia,  Canada,  Korea, Republic of,  Singapore,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline the Number of Concomitant IOP-lowering Medications	The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.	Month 12