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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01517477
First received: January 23, 2012
Last updated: March 23, 2016
Last verified: March 2016

January 23, 2012
March 23, 2016
January 2012
September 2017   (final data collection date for primary outcome measure)
Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT01517477 on ClinicalTrials.gov Archive Site
Mean diurnal IOP <18 mmHg at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Open Angle Glaucoma (POAG)
  • Device: iStent
    Implantation of One iStent through a small temporal clear corneal incision.
  • Device: iStent
    Implantation of Two iStents through a small temporal clear corneal incision
  • Device: iStent
    Implantation of Three iStents through a small temporal clear corneal incision
  • Experimental: First Arm: One iStent
    Device: One iStent
    Intervention: Device: iStent
  • Experimental: Second Arm: Two iStents
    Device: Two iStent devices
    Intervention: Device: iStent
  • Experimental: Third Arm: Three iStents
    Device: Three iStent devices
    Intervention: Device: iStent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
251
September 2017
September 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Armenia
 
NCT01517477
GCF-033
No
Yes
18 month results published in Clinical Ophthalmology 2015:9 2313-2320.
Glaukos Corporation
Glaukos Corporation
Not Provided
Not Provided
Glaukos Corporation
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP