Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
NCT ID: NCT03362931
Last Updated: 2023-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2018-07-19
2022-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XEN45 Glaucoma Treatment System (hereafter referred to as XEN)
XEN45 unilaterally implanted in the study eye
XEN45
XEN45 unilaterally implanted in the study eye
Interventions
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XEN45
XEN45 unilaterally implanted in the study eye
Eligibility Criteria
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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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Marsden Eye Specialists Parramatta /ID# 232761
Paramatta, New South Wales, Australia
Melbourne Eye Specialists /ID# 232767
Fitzroy, Victoria, Australia
Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
Vermont South, Victoria, Australia
Institut de loeil des Laurentides /ID# 232780
Boisbriand, Quebec, Canada
Ophthalmology Clinic Bellevue /ID# 232782
Montreal, Quebec, Canada
Prism Eye Institute /ID# 232917
Mississauga, , Canada
Nuh Medical Centre /ID# 232905
Singapore, , Singapore
Tan Tock Seng Hospital /ID# 233014
Singapore, , Singapore
Seoul National University Hospital /ID# 233099
Seoul, , South Korea
Buddhist Tzu Chi General Hospital /ID# 232664
Hualien City, Hualien, Taiwan
Taipei Veterans General Hospital /ID# 232948
Taipei City, Taipei, Taiwan
Royal Surrey County Hospital /ID# 233028
Guildford, England, United Kingdom
Manchester University NHS Foundation Trust /ID# 232808
Manchester, Lancashire, United Kingdom
Queen Victoria Hospital /ID# 232812
East Grinstead, West Sussex, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 232804
Colchester, , United Kingdom
NHS Lothian /ID# 233052
Edinburgh, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1924-701-007
Identifier Type: -
Identifier Source: org_study_id
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