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
ClinicalTrials.gov 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
Device: iStent
Drug: latanoprost/timolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT00913029     History of Changes
Other Study ID Numbers: Second Line  Second Line Trial 
Study First Received: June 1, 2009
Last Updated: May 18, 2015
Health Authority: Italy: Ethics Committee
Poland: Ministry of Health
Greece: Ethics Committee
Austria: Ethikkommission
Germany: Ethics Commission
Spain: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Eye Diseases
Glaucoma, Open-Angle
Ocular Hypertension
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 26, 2016