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

Phase 4CompletedNCT02006693

AqueSys, Inc.199 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

199

Conditions

Primary Open Angle Glaucoma

Interventions

XEN® Gel StentDEVICE

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

Cataract SurgeryPROCEDURE

Participants diagnosed with a cataract elected to have cataract surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

University of Graz

Graz, Austria

University Augenklinik Salzburg

Salzburg, Austria

Outcomes

Primary Outcomes

Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12

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.

Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)

Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12

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.

Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)

Mean Change From Baseline in IOP in the Study Eyes to Month 24

Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24

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.

Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

Data from ClinicalTrials.gov

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