Clinical trial NCT02448875: Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma
Official title: Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
timeFrame: Baseline (Day -1), Month 12 PostOperative
Secondary outcomes:
measure: Percentage of Subjects With Device-related Ocular Adverse Events
timeFrame: Up to Month 12 PostOperative
measure: Mean Change From Baseline to 12 Months Postoperative in Medicated IOP
timeFrame: Baseline (Day -1), Month 12 PostOperative
measure: Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months
timeFrame: Month 12 PostOperative
measure: Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used
timeFrame: Screening (Day -2), Month 12 PostOperative
Other outcomes:
Locations:
city: Lubeck
country: Germany
facility: Transcend Medical Investigative Site
city: Mainz
country: Germany
facility: Transcend Medical Investigative Site
city: Neubrandenburg
country: Germany
facility: Transcend Medical Investigative Site
city: Panama City
country: Panama
facility: Transcend Medical Investigative Site
city: Warsaw
country: Poland
facility: Transcend Medical Investigative Site
city: Madrid
country: Spain
facility: Transcend Medical Investigative Site
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References: