Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT01252862

First received: December 1, 2010

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 1, 2010
Last Updated Date	March 28, 2013
Start Date ^ICMJE	December 2010
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01252862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 2, 2010)	IOP < 18 mm Hg at Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
Official Title ^ICMJE	A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
Brief Summary	The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma
Detailed Description	This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Subjects With Primary Open-angle Glaucoma (POAG)
Intervention ^ICMJE	Device: iStent Implantation of two iStents through a small temporal clear corneal incision
Study Arm (s)	Experimental: Two iStents devices Two iStents devices will be implanted Intervention: Device: iStent
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	December 2016
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosed with primary open-angle glaucoma (POAG) Subject on one topical hypotensive medication Exclusion Criteria: Traumatic, uveitic, neovascular, or angle closure glaucoma Fellow eye already enrolled
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Armenia

Administrative Information
NCT Number ^ICMJE	NCT01252862
Other Study ID Numbers ^ICMJE	GCF-017
Has Data Monitoring Committee	No
Responsible Party	Glaukos Corporation
Study Sponsor ^ICMJE	Glaukos Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Glaukos Corporation
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top