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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00913029
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Eye Diseases Glaucoma, Open-Angle Glaucoma Device: iStent Drug: latanoprost/timolol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

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
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00913029

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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
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Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
Publications of Results:
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Responsible Party: Glaukos Corporation Identifier: NCT00913029    
Other Study ID Numbers: Second Line
Second Line Trial ( Other Identifier: Glaukos )
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Glaukos Corporation:
primary open angle glaucoma (POAG)
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions