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

AqueSys

Status and phase: Completed; Phase 4

Conditions: Primary Open Angle Glaucoma

Treatments: Device: XEN® Gel Stent; Procedure: Cataract Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006693

MS-001

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

199 participants in 2 patient groups

XEN® Gel Stent

Other group

Description:

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

Treatment:

Device: XEN® Gel Stent

XEN® Gel Stent with Cataract Surgery

Other group

Description:

The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.

Treatment:

Procedure: Cataract Surgery