Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GLD122-P001 | Other Identifier | Alcon |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).
The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.
Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.
Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyPass | Active Comparator | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye |
|
| CyPass30 | Experimental | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic |
|
| CyPass60 | Experimental | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyPass Micro-Stent | Device | Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication | 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). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Baseline (Day -1), Month 12 PostOperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Device-related Ocular Adverse Events | A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alcon Research | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transcend Medical Investigative Site | Lübeck | Germany | ||||
| Transcend Medical Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 192 enrolled, 49 subjects were exited prior to randomization. In addition, one randomized subject discontinued prior to treatment. This reporting group includes all treated subjects, Dose Selection Phase and Expansion Phase (142 subjects).
Subjects were recruited from 6 study centers located in Germany (3), Poland (1), Spain (1), and Panama (1).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CyPass | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye |
| FG001 | CyPass30 | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic |
| FG002 | CyPass60 | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CyPass | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye |
| BG001 | CyPass30 | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication | 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). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Full Analysis Set with data available | Posted | Number | percentage of subjects | Baseline (Day -1), Month 12 PostOperative |
|
Surgery through study completion, an average of 12 months.
Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CyPass Ocular | Subjects with CyPass Micro-Stent implantation | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorder | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (21.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Project Lead, CDMA Surgical | Alcon Research | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2014 | Apr 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2017 | Apr 11, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Viscoelastic | Device | Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent |
|
| Up to Month 12 PostOperative |
| Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Baseline (Day -1), Month 12 PostOperative |
| Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months | The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Month 12 PostOperative |
| Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used | The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Screening (Day -2), Month 12 PostOperative |
| Mainz |
| Germany |
| Transcend Medical Investigative Site | Neubrandenburg | Germany |
| Transcend Medical Investigative Site | Panama City | Panama |
| Transcend Medical Investigative Site | Warsaw | Poland |
| Transcend Medical Investigative Site | Madrid | Spain |
| Investigator Decision |
|
| Withdrawal by Subject |
|
| BG002 | CyPass60 | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic |
| OG002 | CyPass60 | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
|
|
| Secondary | Percentage of Subjects With Device-related Ocular Adverse Events | A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Full Analysis Set | Posted | Number | percentage of subjects | Up to Month 12 PostOperative |
|
|
|
| Secondary | Mean Change From Baseline to 12 Months Postoperative in Medicated IOP | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Full Analysis Set with data available | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (Day -1), Month 12 PostOperative |
|
|
|
| Secondary | Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months | The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Full Analysis Set with data available | Posted | Number | percentage of eyes | Month 12 PostOperative | Eyes | Eyes |
|
|
|
| Secondary | Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used | The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study. | Full Analysis Set with data available | Posted | Mean | Standard Deviation | IOP-lowering medications | Screening (Day -2), Month 12 PostOperative |
|
|
|
| 60 |
| 6 |
| 60 |
| 38 |
| 60 |
| EG001 | CyPass Nonocular | Subjects with CyPass Micro-Stent implantation | 0 | 60 | 4 | 60 | 0 | 60 |
| EG002 | CyPass30 Ocular | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | 0 | 21 | 1 | 21 | 13 | 21 |
| EG003 | CyPass30 Nonocular | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | 0 | 21 | 0 | 21 | 0 | 21 |
| EG004 | CyPass60 Ocular | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | 0 | 61 | 7 | 61 | 37 | 61 |
| EG005 | CyPass60 Nonocular | Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | 0 | 61 | 2 | 61 | 0 | 61 |
| Hypotony of eye | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Narrow anterior chamber angle | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Hyphaema | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Intraocular pressure fluctuation | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (21.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (21.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Measurements |
|---|---|
|
| Change from Baseline @ Month 12 |
|
|