Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)

May 18, 2015 updated by: Glaukos Corporation

A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia
        • SV Malayan Ophthalmological Center
  • Austria
      • Wien, Austria, 1090
        • Allgemeines Krankenhaus Wien
  • France
      • Lyon, France, 69437
        • CHU de Lyon Hopital Edouard Herriot
      • Paris, France, 75012
        • CHNO des Quinze-Vingts
  • Germany
      • Bochum, Germany, 44892
        • Knapschaftskrankenhaus Bochum Langendreer
      • Erfurt, Germany, 99089
        • Helios Cliniic
      • Erlangen, Germany
        • Universitatsklinkum Erlangen
  • Greece
      • Thessaloniki, Greece, 546 36
        • AHEPA Hospital
  • Italy
      • Parma, Italy, 43100
        • Universita'degli Studi di Parma
      • Torino, Italy, 10128
        • Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
      • Udine, Italy, 33100
        • Azienda Ospedaliera S. Maria della Misericordia
  • Poland
      • Warsaw, Poland, 00-909
        • Military Health Service Institute
  • Spain
      • Alicante, Spain, 03186
        • Hospital Torrevieja Salud, UTE
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
  • United Kingdom
      • Bedford, United Kingdom
        • Hinchingbrooke Hospital Moorfields

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma
  • Male or female at least 18 years of age and able to provide written informed consent
  • Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
  • Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

  • Angle closure glaucoma
  • Secondary glaucomas
  • Prior glaucoma procedures
  • Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
Device: iStent
iStent
Other Names:
  • stent, Trabecular micro bypass
Active Comparator: Medication
One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.
Drug: latanoprost/timolol
Combination latanoprost/timolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean intraocular pressure (IOP)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Second Line
  • Second Line Trial (Other Identifier: Glaukos)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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