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

Open Angle Glaucoma Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02448875
Study type Interventional
Source Alcon Research
Contact
Status Completed
Phase N/A
Start date June 21, 2013
Completion date June 22, 2017
View Details
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