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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03362931
Registration number
NCT03362931
Ethics application status
Date submitted
30/11/2017
Date registered
5/12/2017
Date last updated
17/05/2023
Titles & IDs
Public title
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
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Scientific 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
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Secondary ID [1]
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1924-701-007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glaucoma
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Angle-Closure
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - XEN45
Experimental: XEN45 Glaucoma Treatment System (hereafter referred to as XEN) - XEN45 unilaterally implanted in the study eye
Treatment: Devices: XEN45
XEN45 unilaterally implanted in the study eye
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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IOP will be measured using a Goldmann applanation tonometer
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Timepoint [1]
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Month 12
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Secondary outcome [1]
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Change From Baseline the Number of Concomitant IOP-lowering Medications
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Assessment method [1]
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The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
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Timepoint [1]
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Month 12
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/03/2022
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Sample size
Target
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Accrual to date
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Final
65
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Marsden Eye Specialists Parramatta /ID# 232761 - Paramatta
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Recruitment hospital [2]
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Melbourne Eye Specialists /ID# 232767 - Fitzroy
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Recruitment hospital [3]
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Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765 - Vermont South
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Recruitment postcode(s) [1]
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2150 - Paramatta
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Recruitment postcode(s) [2]
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VIC3065 - Fitzroy
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Recruitment postcode(s) [3]
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3133 - Vermont South
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Quebec
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Canada
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State/province [2]
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Mississauga
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Country [3]
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Korea, Republic of
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State/province [3]
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Seoul
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Singapore
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State/province [4]
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Singapore
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Taiwan
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State/province [5]
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Taipei
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Country [6]
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Taiwan
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State/province [6]
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Hualien
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Country [7]
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United Kingdom
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State/province [7]
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England
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Country [8]
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United Kingdom
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State/province [8]
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Lancashire
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Country [9]
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United Kingdom
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State/province [9]
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West Sussex
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Country [10]
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United Kingdom
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State/province [10]
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Colchester
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Country [11]
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United Kingdom
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State/province [11]
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Edinburgh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with
Angle Closure Glaucoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03362931
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ALLERGAN INC.
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03362931
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