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OpenTrials
Completed

NCT Number: NCT02006693

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN® Gel Stent

Device

The XEN® Gel Stent (XEN45 implant) was placed in the study eye.

Other names: XEN Glaucoma Implant, XEN Gel Stent, XEN45 Implant

cataract surgery

Procedure

Participants diagnosed with a cataract elected to have cataract surgery.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AqueSys, Inc.

Industry

Registry information

Official study title

Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 10, 2013
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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