Overview

This trial is active, not recruiting.

Conditions glaucoma, glaucoma, open angle
Treatment aquesys xen 45 glaucoma implant
Phase phase 3
Sponsor AqueSys, Inc.
Collaborator Allergan
Start date January 2013
End date February 2016
Trial size 60 participants
Trial identifier NCT02036541, P13-001

Summary

To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
aquesys xen 45 glaucoma implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

Primary Outcomes

Measure
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications
time frame: 12 Months

Secondary Outcomes

Measure
Mean change in IOP from baseline
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 45 years old.

Inclusion Criteria: - Diagnosis of Refractory Glaucoma - Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg - Visual field mean deviation score of -3 dB or worse - Shaffer Angle Grade ≥ 3 - Area of free, healthy and mobile conjunctiva in the targeted quadrant Exclusion Criteria: - Active Neovascular Glaucoma - Previous glaucoma shunt/valve in the targeted quadrant - History of corneal surgery, opacities or disease/pathology - Anticipated need for ocular surgery - Non-study eye with BCVA of 20/200 or worse

Additional Information

Official title A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
Description A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AqueSys, Inc..