Clinical trial NCT03362931: Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Angle-Closure
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Month 12
Secondary outcomes:
measure: Change From Baseline the Number of Concomitant IOP-lowering Medications
timeFrame: Month 12
Other outcomes:
Locations:
city: Paramatta
country: Australia
facility: Marsden Eye Specialists Parramatta /ID# 232761
state: New South Wales
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists /ID# 232767
state: Victoria
city: Vermont South
country: Australia
facility: Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
state: Victoria
city: Boisbriand
country: Canada
facility: Institut de loeil des Laurentides /ID# 232780
state: Quebec
city: Montreal
country: Canada
facility: Ophthalmology Clinic Bellevue /ID# 232782
state: Quebec
city: Mississauga
country: Canada
facility: Prism Eye Institute /ID# 232917
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 233099
city: Singapore
country: Singapore
facility: Nuh Medical Centre /ID# 232905
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital /ID# 233014
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 232948
state: Taipei
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital /ID# 232664
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital /ID# 233028
state: England
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust /ID# 232808
state: Lancashire
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital /ID# 232812
state: West Sussex
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust /ID# 232804
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 233052
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: