NCT02448875

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 30, 2019

Completed
Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

May 12, 2015

Results QC Date

May 6, 2019

Last Update Submit

May 29, 2019

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Percentage of Subjects With Device-related Ocular Adverse Events

    Up to Month 12 PostOperative

  • Mean Change From Baseline to 12 Months Postoperative in Medicated IOP

    Baseline (Day -1), Month 12 PostOperative

  • Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months

    Month 12 PostOperative

  • Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used

    Screening (Day -2), Month 12 PostOperative

Study Arms (3)

CyPass

ACTIVE COMPARATOR

CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye

Device: CyPass Micro-Stent

CyPass30

EXPERIMENTAL

CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic

Device: CyPass Micro-StentDevice: Viscoelastic

CyPass60

EXPERIMENTAL

CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic

Device: CyPass Micro-StentDevice: Viscoelastic

Interventions

CyPass Micro-StentDEVICE

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.

Also known as: Model 2FX
CyPassCyPass30CyPass60
ViscoelasticDEVICE

Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent

CyPass30CyPass60

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of open angle glaucoma;
  • Unmedicated IOP between 21 - 36 mmHg, inclusive;
  • Normal angle anatomy at site of intended CyPass Micro-Stent implantation.

You may not qualify if:

  • Advanced glaucoma;
  • Prior incisional glaucoma surgery;
  • Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
  • Clinically significant ocular pathology other than glaucoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Transcend Medical Investigative Site

Lübeck, Germany

Location

Transcend Medical Investigative Site

Mainz, Germany

Location

Transcend Medical Investigative Site

Neubrandenburg, Germany

Location

Transcend Medical Investigative Site

Panama City, Panama

Location

Transcend Medical Investigative Site

Warsaw, Poland

Location

Transcend Medical Investigative Site

Madrid, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Results Point of Contact

Title
Senior Clinical Project Lead, CDMA Surgical
Organization
Alcon Research
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Alcon Research

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 20, 2015

Study Start

June 21, 2013

Primary Completion

June 22, 2017

Study Completion

June 22, 2017

Last Updated

June 12, 2019

Results First Posted

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)PA(1)ES(1)PL(1)