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

Phase 3

Completed

• Conditions: Angle-Closure; Glaucoma

• Registration Number: NCT03362931
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-05
• Study Start: 2018-07-19
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Results First Submitted: 2023-03-07
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Month 12	IOP will be measured using a Goldmann applanation tonometer

Secondary Outcome Measures

Name	Time	Method
Change From Baseline the Number of Concomitant IOP-lowering Medications	Month 12	The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.

Trial Locations

Locations (16)

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

Seoul National University Hospital /ID# 233099; 🇰🇷 Seoul, Korea, Republic of

Nuh Medical Centre /ID# 232905; 🇸🇬 Singapore, Singapore

Tan Tock Seng Hospital /ID# 233014; 🇸🇬 Singapore, Singapore

Taipei Veterans General Hospital /ID# 232948; 🇨🇳 Taipei City, Taipei, Taiwan

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