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

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ClinicalTrials.gov Identifier: NCT03362931
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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
Estimated Study Start Date : July 31, 2018
Estimated Primary Completion Date : June 12, 2020
Estimated Study Completion Date : June 12, 2020

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.



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

    • 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 ClinicalTrials.gov identifier (NCT number): NCT03362931


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@allergan.com

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 03080
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 06351
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119074
Singapore Eye Research Institute Not yet recruiting
Singapore, Singapore, 168751
Tan Tock Seng Hospital Not yet recruiting
Singapore, Singapore, 308433
Taiwan
Buddhist Tzu Chi General Hospital Not yet recruiting
Hualien, Taiwan, 97002
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan, 11217
Tri-Service General Hospital Not yet recruiting
Taipei, Taiwan, 11447
Sponsors and Collaborators
Allergan
Investigators
Study Director: Eleonora Safyan Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03362931     History of Changes
Other Study ID Numbers: 1924-701-007
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases