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A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

This study is currently recruiting participants.
Verified March 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01252914
First received: December 1, 2010
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.


Condition Intervention Phase
Subject With Primary Open-angle Glaucoma (POAG)
 Device: iStent Supra Stent
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean diurnal 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 ]

Other Outcome Measures:
  • Safety [ Time Frame: 0-61 months ] [ Designated as safety issue: Yes ]

    Rate of ocular adverse events through 61 months

    • Findings from IOP, best corrected visual acuity, visual field, specular microscopy measurements
    • Findings from slit-lamp, fundus and gonioscopic examinations


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One iStent Supra Stent and medication
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
 Device: iStent Supra Stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision

Detailed Description:

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

  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)
  • Subjects on two topical hypotensive medications

Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252914

Contacts
Contact: Tim McCauley 949-367-9600 ext 242 timmccauley@glaukos.com

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

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01252914     History of Changes
Other Study ID Numbers: GCF-019
Study First Received: December 1, 2010
Last Updated: March 28, 2013
Health Authority: Armenia: Ministry of Health

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Surgery
Ocular Hypertension
Eye Diseases

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013