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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000013243 | Registry Identifier | UMIN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ex-PRESS® Glaucoma Filtration Device, Model P50PL | Device |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon, A Novartis Division | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Japan, Ltd for Trial Locations | Tokyo | 107-0052 | Japan |
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Subjects were recruited from 3 study centers located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all subjects after use of the investigational device (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat, with non-missing data | Posted | Mean | Standard Deviation | mmHG | Month 3, Month 6, Month 12 Post-Operative | Eyes | Eyes |
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Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Choroidal detachment | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate, Medical Group 1, Japan | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Intraocular Pressure (IOP) | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | This analysis population includes all subjects treated with the investigational device, whose test/assessment data after the use of the device were available, having no inclusion/exclusion criteria violation substantially affecting the efficacy evaluation (Intent-to-Treat Analysis Set). | Mean | Standard Deviation | mmHG |
|
| Counts |
|---|
| Participants |
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| Eyes |
|
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| Primary | 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. | Intent-to-Treat, with non-missing data | Posted | Mean | Standard Deviation | mmHG | Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative | Eyes | Eyes |
|
|
|
| Primary | 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. | Intent-to-Treat, with non-missing data | Posted | Mean | Standard Deviation | percent change | Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative | Eyes | Eyes |
|
|
|
| Primary | 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. | Intent-to-Treat, with non-missing data | Posted | Number | percentage of eyes | Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative | Eyes | Eyes |
|
|
|
| Primary | 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. | Intent-to-Treat Analysis Set with non-missing data | Posted | Number | percentage of eyes | Month 3, Month 6, Month 12 Post-Operative | Eyes | Eyes |
|
|
|
| Primary | 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. | Intent-to-Treat, with non-missing data | Posted | Number | percentage of eyes | Month 3, Month 6, Month 12 Post-Operative | Eyes | Eyes |
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| 0 |
| 37 |
| 0 |
| 37 |
| 13 |
| 37 |
| Hyphaema | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Corneal epithelium defect | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Macular fibrosis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Blebitis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Optic disc haemorrhage | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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