Status:
COMPLETED
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Lead Sponsor:
Allergan
Conditions:
Glaucoma
Angle-Closure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03362931
Start Date
July 19 2018
End Date
March 18 2022
Last Update
May 17 2023
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Marsden Eye Specialists Parramatta /ID# 232761
Paramatta, New South Wales, Australia, 2150
2
Melbourne Eye Specialists /ID# 232767
Fitzroy, Victoria, Australia, VIC3065
3
Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
Vermont South, Victoria, Australia, 3133
4
Institut de loeil des Laurentides /ID# 232780
Boisbriand, Quebec, Canada, J7H 0E8