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 December 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01252914
First received: December 1, 2010
Last updated: December 16, 2013
Last verified: December 2013
  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:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean diurnal Intraocular Pressure 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 Intraocular Pressure < 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 Intraocular Pressure, 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: December 16, 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 April 17, 2014