Overview

This trial has been completed.

Condition glaucoma
Treatment ex-press™ glaucoma filtration device, model p50pl
Sponsor Alcon Research
Start date February 2014
End date October 2016
Trial size 37 participants
Trial identifier NCT02246777, ALJ-P2013-1, UMIN000013243

Summary

The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS™ Glaucoma Filtration Device (Ex-PRESS) in Japanese patients with normal tension glaucoma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Ex-PRESS™ Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
ex-press™ glaucoma filtration device, model p50pl

Primary Outcomes

Measure
Mean intraocular pressure (IOP)
time frame: Up to Month 12
Percentage of patients with IOP lowering rate of 20% or more from baseline up to Month 12
time frame: Up to Month 12
Percentage of patients receiving drug therapy for glaucoma necessary to maintain the IOP
time frame: Up to Month 12
Percentage of patients receiving secondary surgical treatment (including laser therapy) necessary to maintain the IOP
time frame: Up to Month 12

Eligibility Criteria

All participants at least 20 years old.

Inclusion Criteria: - Diagnosis of normal tension glaucoma. - Indicated for filtration surgery using Ex-PRESS. - Understand and provide Informed Consent. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Women who are pregnant, lactating, or planning to be pregnant during the study period. - Diagnosis of angle closure glaucoma or secondary glaucoma. - History of glaucoma surgery. - Ophthalmologic surgery within the past 6 months. - Difficulty with applanation tonometry measurement. - Corneal dystrophy. - Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye. - Severe blepharitis or dry eye. - History of metal allergy. - Other protocol-defined exclusion criteria may apply.

Additional Information

Official title Assessment of Efficacy and Safety of the Filtration Surgery for Normal Tension Glaucoma Using Ex-PRESS
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Alcon Research.