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Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01517477
First received: January 23, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.


Condition Intervention Phase
Primary Open Angle Glaucoma (POAG)
Device: iStent
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, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean diurnal intraocular (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean diurnal IOP <18 mmHg at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Arm: One iStent
Device: One iStent
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.
Experimental: Second Arm: Two iStents
Device: Two iStent devices
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Experimental: Third Arm: Three iStents
Device: Three iStent devices
Device: iStent
Implantation of Three iStents through a small temporal clear corneal incision

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on two topical hypotensive medications

Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled
  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 ClinicalTrials.gov identifier: NCT01517477

Contacts
Contact: Tim McCauley 949-367-9600 ext 248 timmccauley@glaukos.com
Contact: Jeff Wells, PharmD, MBA 949-367-9600 ext 227

Locations
Armenia
S.V. Malayan's Ophthalmology Centre Recruiting
Yerevan, Armenia, 375108
Contact: Lilit Voskanyan, MD    +37410264424    lilitvosk@mail.ru   
Principal Investigator: Lilit Voskanyan, MD, PhD         
Sub-Investigator: Amadeu Carceller Guillamet, MD         
Sub-Investigator: Antonio Fea, MD, PhD         
Sub-Investigator: L. Jay Katz, MD         
Sub-Investigator: Jeffrey Liebmann, MD         
Sub-Investigator: Yana Oganova, MD         
Sub-Investigator: Vahan Papoyan, MD         
Sub-Investigator: Levon Nersisyan, MD         
Sponsors and Collaborators
Glaukos Corporation
  More Information

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01517477     History of Changes
Other Study ID Numbers: GCF-033
Study First Received: January 23, 2012
Last Updated: December 16, 2013
Health Authority: Armenia: Ministry of Health

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
surgery
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

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

ClinicalTrials.gov processed this record on November 20, 2014