Back to resultsAlcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Ex-PRESS® Glaucoma Filtration Device, Model P50PL
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma
Eligibility Criteria
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.
Sites / Locations
- Contact Alcon Japan, Ltd for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ex-PRESS
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02246777
Brief Title
Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients
Official Title
Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 26, 2014 (Actual)
Primary Completion Date
October 24, 2016 (Actual)
Study Completion Date
October 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ex-PRESS
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Ex-PRESS® Glaucoma Filtration Device, Model P50PL
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
Description
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.
Time Frame
Month 3, Month 6, Month 12 Post-Operative
Title
Change From Baseline in IOP
Description
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.
Time Frame
Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Title
Percent Change From Baseline in IOP
Description
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.
Time Frame
Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Title
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
Description
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.
Time Frame
Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Title
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
Description
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.
Time Frame
Month 3, Month 6, Month 12 Post-Operative
Title
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
Description
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.
Time Frame
Month 3, Month 6, Month 12 Post-Operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, A Novartis Division
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Japan, Ltd for Trial Locations
City
Tokyo
ZIP/Postal Code
107-0052
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients
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