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

This study has been completed.
Information provided by (Responsible Party):
Glaukos Corporation Identifier:
First received: June 1, 2009
Last updated: May 18, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Eye Diseases Glaucoma, Open-Angle Glaucoma Device: iStent Drug: latanoprost/timolol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

Resource links provided by NLM:

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean intraocular pressure (IOP) [ Time Frame: 1 year ]

Enrollment: 192
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
Device: iStent
Other Name: 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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00913029

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

Responsible Party: Glaukos Corporation Identifier: NCT00913029     History of Changes
Other Study ID Numbers: Second Line
Second Line Trial ( Other Identifier: Glaukos )
Study First Received: June 1, 2009
Last Updated: May 18, 2015

Keywords provided by Glaukos Corporation:
primary open angle glaucoma (POAG)

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents processed this record on August 21, 2017