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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03362931
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : August 31, 2020
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Glaucoma, Angle-Closure Device: XEN45 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : November 9, 2021
Estimated Study Completion Date : November 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: XEN45 Glaucoma Treatment System (hereafter referred to as XEN)
XEN45 unilaterally implanted in the study eye
Device: XEN45
XEN45 unilaterally implanted in the study eye

Primary Outcome Measures :
  1. Percentage of patients achieving at least a 20% reduction from baseline Hour 0 IOP while on the same number or fewer IOP lowering medications [ Time Frame: Baseline to Month 12 ]
    IOP will be measured using a Goldmann applanation tonometer

Secondary Outcome Measures :
  1. Change from baseline the number of concomitant IOP-lowering medications [ Time Frame: Baseline to Month 12 ]
    The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    • incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions
    • corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03362931

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Contact: Clinical Trials Registry Team 877-277-8566

Show Show 29 study locations
Sponsors and Collaborators
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Study Director: Eleonora Safyan Allergan
Additional Information:
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Responsible Party: Allergan Identifier: NCT03362931    
Other Study ID Numbers: 1924-701-007
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases