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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ex-PRESS<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma