Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT01444105

First received: September 28, 2011

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2011

Last Updated Date

March 28, 2013

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

January 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01444105 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Official Title ^ICMJE

A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Brief Summary

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Open-angle Glaucoma

Intervention ^ICMJE

Device: iStent
Implantation of two iStent devices
Other: SLT
Laser treatment

Study Arm (s)

Active Comparator: iStent
implantation of two iStent devices

Intervention: Device: iStent
Active Comparator: SLT
Laser treatment

Intervention: Other: SLT

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

Estimated Completion Date

April 2017

Estimated Primary Completion Date

January 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
Prior stent implantations (study eye)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Armenia

Administrative Information

NCT Number ^ICMJE

NCT01444105

Other Study ID Numbers ^ICMJE

GCF-028

Has Data Monitoring Committee

Responsible Party

Glaukos Corporation

Study Sponsor ^ICMJE

Glaukos Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lilit A Voskanyan, MD, PhD

S.V. Malayan Ophthalmological Center, Yerevan, Armenia

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

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