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

NCT02246777 | Completed Results

• 2 other identifiers: ALJ-P2013-1UMIN000013243
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 subjects with normal tension glaucoma.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Ex-PRESS

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

Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL

Interventions

Ex-PRESS® Glaucoma Filtration Device, Model P50PL DEVICE

Ex-PRESS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of normal tension glaucoma.
• Indicated for filtration surgery using Ex-PRESS®.
• Understand and provide Informed Consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Japan, Ltd for Trial Locations

Tokyo, 107-0052, Japan

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Limitations and Caveats

This study was a single-arm study with filtration surgery using EX-PRESS®. Although target sample size was 45 patients, only 32 patients (37 eyes) were enrolled due to a small number of patients meeting eligibility criteria of the study.

Results Point of Contact

• Title: Associate, Medical Group 1, Japan
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon, A Novartis Division

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: February 26, 2014
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: July 20, 2018
• Results First Posted: July 20, 2018

Record last verified: 2018-07

Locations

JP (1)