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

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:
NCT01252914
First received: December 1, 2010
Last updated: December 16, 2013
Last verified: December 2013

December 1, 2010
December 16, 2013
December 2010
June 2017   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01252914 on ClinicalTrials.gov Archive Site
Mean diurnal Intraocular Pressure < 18 mmHg at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Mean diurnal IOP < 18 mmHg at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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
Not Provided
 
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent

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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Subject With Primary Open-angle Glaucoma (POAG)
Device: iStent Supra Stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision
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
Intervention: Device: iStent Supra Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Tim McCauley 949-367-9600 ext 242 timmccauley@glaukos.com
Armenia
 
NCT01252914
GCF-019
Not Provided
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