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

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ClinicalTrials.gov Identifier: NCT02006693
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
AqueSys, Inc.

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 10, 2013
Results First Submitted Date  ICMJE June 29, 2018
Results First Posted Date  ICMJE April 22, 2019
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE December 5, 2013
Actual Primary Completion Date February 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • The number of IOP lowering medications compared to the number of preoperative IOP lowering medications. [ Time Frame: 24 month visit ]
  • The number of IOP lowering medications compared to the number of preoperative IOP lowering medications. [ Time Frame: 12 month visit ]
  • Comparing the intraocular pressure to the preoperative medicated intraocular pressure. [ Time Frame: 24 month visit ]
  • Comparing the intraocular pressure to the preoperative medicated intraocular pressure. [ Time Frame: 12 month visit ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Official Title  ICMJE Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Open Angle Glaucoma
Intervention  ICMJE
  • Device: XEN® Gel Stent
    The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
    Other Names:
    • XEN Glaucoma Implant
    • XEN Gel Stent
    • XEN45 Implant
  • Procedure: Cataract Surgery
    Participants diagnosed with a cataract elected to have cataract surgery.
Study Arms  ICMJE
  • XEN® Gel Stent
    The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
    Intervention: Device: XEN® Gel Stent
  • XEN® Gel Stent with Cataract Surgery
    The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
    Intervention: Procedure: Cataract Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
199
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2013)
200
Actual Study Completion Date  ICMJE January 26, 2017
Actual Primary Completion Date February 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Germany,   Italy,   Poland,   Spain,   Switzerland,   United Kingdom,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02006693
Other Study ID Numbers  ICMJE MS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AqueSys, Inc.
Study Sponsor  ICMJE AqueSys, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vanessa Vera, MD Allergan
PRS Account AqueSys, Inc.
Verification Date January 2019

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