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.
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

January 23, 2012
December 16, 2013
January 2012
July 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
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
 
Safety and Efficacy of 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.
 
Recruiting
120
October 2017
July 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
Yes
Contact: Tim McCauley 949-367-9600 ext 248 timmccauley@glaukos.com
Contact: Jeff Wells, PharmD, MBA 949-367-9600 ext 227
Armenia
 
NCT01517477
GCF-033
No
Glaukos Corporation
Glaukos Corporation
Not Provided
Not Provided
Glaukos Corporation
December 2013

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