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

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ClinicalTrials.gov Identifier: NCT00913029
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Study Design

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
Primary Completion Date : September 2012
Study Completion Date : September 2012


Arms and Interventions

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 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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00913029


Locations
Armenia
SV Malayan Ophthalmological Center
Yerevan, Armenia
Austria
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
France
CHU de Lyon Hopital Edouard Herriot
Lyon, France, 69437
CHNO des Quinze-Vingts
Paris, France, 75012
Germany
Knapschaftskrankenhaus Bochum Langendreer
Bochum, Germany, 44892
Helios Cliniic
Erfurt, Germany, 99089
Universitatsklinkum Erlangen
Erlangen, Germany
Greece
AHEPA Hospital
Thessaloniki, Greece, 546 36
Italy
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
Poland
Military Health Service Institute
Warsaw, Poland, 00-909
Spain
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
Investigators
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
More Information

Publications:
Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00913029     History of Changes
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)
OAG
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension
Timolol
Latanoprost
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents