Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Overview

The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.

Full Title of Study: “Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 9, 2016

Interventions

  • Device: XEN® Gel Stent
    • The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
  • Procedure: Cataract Surgery
    • Participants diagnosed with a cataract elected to have cataract surgery.

Arms, Groups and Cohorts

  • Other: XEN® Gel Stent
    • The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
  • Other: XEN® Gel Stent with Cataract Surgery
    • The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
    • Time Frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
    • IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
  • Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
    • Time Frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
    • The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
  • Mean Change From Baseline in IOP in the Study Eyes to Month 24
    • Time Frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
    • IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
  • Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
    • Time Frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
    • The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of primary open angle glaucoma
  • Participants are taking at least one and no more than four topical IOP-lowering medications.

Exclusion Criteria

  • Angle Closure Glaucoma
  • Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
  • Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
  • Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AqueSys, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vanessa Vera, MD, Study Director, Allergan

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