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

November 30, 2017
December 5, 2017
December 5, 2017
March 30, 2018
June 12, 2020   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
A Prospective, Multicenter Clinical Trial Designed to Evaluate the 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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma, Angle-Closure
Device: XEN45
XEN45 unilaterally implanted in the study eye
Experimental: XEN45 Glaucoma Treatment System (hereafter referred to as XEN)
XEN45 unilaterally implanted in the study eye
Intervention: Device: XEN45
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
65
June 12, 2020
June 12, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@allergan.com
Korea, Republic of,   Singapore,   Taiwan
 
 
NCT03362931
1924-701-007
Not Provided
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
Plan to Share IPD: No
Allergan
Allergan
Not Provided
Study Director: Eleonora Safyan Allergan
Allergan
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP