NCT01052558

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

22 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

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

January 13, 2010

Last Update Submit

May 18, 2015

Conditions

Glaucoma

Keywords

Open angleGlaucomaCataractSurgeryIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.

    12 months

Study Arms (2)

Cataract Surgery Only

ACTIVE COMPARATOR
Procedure: Cataract Surgery

Treatment with Cataract Surgery & Stents

EXPERIMENTAL

Ab interno trabecular micro-bypass stent surgery

Device: iStent Inject (GTS400)

Interventions

iStent Inject (GTS400)DEVICE

Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.

Also known as: Cataract surgery, stent implantation
Treatment with Cataract Surgery & Stents
Cataract SurgeryPROCEDURE

Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.

Cataract Surgery Only

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with open-angle glaucoma in the study eye
  • Subject must be on 1 to 3 glaucoma medications
  • Subject able and willing to attend follow up visits for two years postop
  • Subject able and willing to sign informed consent

You may not qualify if:

  • Pseudoexfoliative and pigmentary glaucoma
  • Prior glaucoma surgery of any type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Boozman-Hof Regional Eye Clinic

Rogers, Arkansas, 72756, United States

Location

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

Glaucoma Consultants of Colorado

Parker, Colorado, 80134, United States

Location

The Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

International Eye Center

Tampa, Florida, 33603, United States

Location

Clayton Eye Center / Eye Care Centers Management, Inc.

Morrow, Georgia, 30260, United States

Location

Chicago Eye Specialists

Chicago, Illinois, 60619, United States

Location

Whitson Vision, PC

Indianapolis, Indiana, 46240, United States

Location

D'Ambrosio Eye Care

Lancaster, Massachusetts, 01523, United States

Location

Kresge Eye Institute

Detroit, Michigan, 48201, United States

Location

Discover Vision Centers

Independence, Missouri, 64055, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

St. John's Medical Research Institute

Springfield, Missouri, 65807, United States

Location

Las Vegas Physician Research Group

Henderson, Nevada, 75965, United States

Location

Shepherd Eye Center

Las Vegas, Nevada, 89121, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

Thomas Mundorf, MD

Charlotte, North Carolina, 28204, United States

Location

Laurel Eye Clinic

Brookville, Pennsylvania, 15825, United States

Location

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

Vance Thompson Vision / Sanford Clinic

Sioux Falls, South Dakota, 57105, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

Location

MeSH Terms

Conditions

GlaucomaCataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jeff Wells, PharmD, MBA

    Glaukos Corporation

    STUDY DIRECTOR

  • Jay Katz, MD

    Wills Eye Institute; Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 20, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

US(22)