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OpenTrials
Completed

NCT Number: NCT03362931

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

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

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Key information

Conditions

Glaucoma Angle-Closure Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Marsden Eye Specialists Parramatta /ID# 232761, Parramatta, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN45

Device

XEN45 unilaterally implanted in the study eye

Primary outcomes

  1. 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

    Time frame: Month 12

    IOP will be measured using a Goldmann applanation tonometer

Secondary outcomes

  1. Change From Baseline the Number of Concomitant IOP-lowering Medications

    Time frame: Month 12

    The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2017
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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