Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma

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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 107-0052
    • Contact Alcon Japan, Ltd for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ex-PRESS; 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	Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure (IOP)	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.	Month 3, Month 6, Month 12 Post-Operative
Change From Baseline in IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Percent Change From Baseline in IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.	Month 3, Month 6, Month 12 Post-Operative
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.	Month 3, Month 6, Month 12 Post-Operative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon, A Novartis Division, Alcon Japan, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2014
• Primary Completion (Actual): October 24, 2016
• Study Completion (Actual): October 24, 2016

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: ALJ-P2013-1; UMIN000013243 (Registry Identifier: UMIN)