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

Not Applicable

Completed

Conditions: Glaucoma

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

Registration Number: NCT02246777

Lead Sponsor: Alcon Research

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ex-PRESS	Ex-PRESS® Glaucoma Filtration Device, Model P50PL	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

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative	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.
Percent Change From Baseline in IOP	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative	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.
Change From Baseline in IOP	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative	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.
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP	Month 3, Month 6, Month 12 Post-Operative	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.
Mean Intraocular Pressure (IOP)	Month 3, Month 6, Month 12 Post-Operative	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.
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP	Month 3, Month 6, Month 12 Post-Operative	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.