Overview

This trial has been completed.

Condition glaucoma
Treatment ex-press™ glaucoma filtration device, model p50pl
Sponsor Alcon Research
Start date April 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

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Male or female 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 November 2016.
Information provided to ClinicalTrials.gov by Alcon Research.