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

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. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: XEN® Gel Stent Procedure: Cataract Surgery Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
Actual Study Start Date : December 5, 2013
Actual Primary Completion Date : February 9, 2016
Actual Study Completion Date : January 26, 2017


Arm Intervention/treatment
XEN® Gel Stent
The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
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

XEN® Gel Stent with Cataract Surgery
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Procedure: Cataract Surgery
Participants diagnosed with a cataract elected to have cataract surgery.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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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 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

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): NCT02006693


Locations
Show Show 21 study locations
Sponsors and Collaborators
AqueSys, Inc.
Investigators
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Study Director: Vanessa Vera, MD Allergan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AqueSys, Inc.
ClinicalTrials.gov Identifier: NCT02006693    
Other Study ID Numbers: MS-001
First Posted: December 10, 2013    Key Record Dates
Results First Posted: April 22, 2019
Last Update Posted: April 22, 2019
Last Verified: January 2019
Keywords provided by AqueSys, Inc.:
XEN
Primary Open Angle Glaucoma
Filtration Device
Ab interno
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases