Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: CyPass Micro-Stent
* Device: Viscoelastic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of open angle glaucoma; Unmedicated IOP between 21 - 36 mmHg, inclusive; Normal angle anatomy at site of intended CyPass Micro-Stent implantation. Exclusion Criteria: Advanced glaucoma; Prior incisional glaucoma surgery; Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma; Clinically significant ocular pathology other than glaucoma.

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CyPass<br>CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye | Device: CyPass Micro-Stent<br>* 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.<br>* Other names: Model 2FX;|
| Experimental: CyPass30<br>CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic | Device: CyPass Micro-Stent<br>* 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.<br>* Other names: Model 2FX;Device: Viscoelastic<br>* Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent<br>|
| Experimental: CyPass60<br>CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic | Device: CyPass Micro-Stent<br>* 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.<br>* Other names: Model 2FX;Device: Viscoelastic<br>* Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |