Purpose of This Study is to Evaluate the Safety and Efficacy of 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:
NCT01252849
First received: December 1, 2010
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.


Condition Intervention Phase
Primary Open Angle Glaucoma (POAG)
Device: iStent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Mean diurnal IOP <18 mmHg at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Arm: One iStent, medication
Device: One iStent, medication
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.
Experimental: Second Arm: Two iStents, medication
Device: Two iStent devices, medication
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Experimental: Third Arm: Three iStents, medication
Device: Three iStent devices, medication
Device: iStent
Implantation of Three iStents through a small temperal clear corneal incision

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252849

Locations
Armenia
S.V. Malayan's Ophthalmology Centre
Yerevan, Armenia, 375108
Sponsors and Collaborators
Glaukos Corporation
  More Information

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01252849     History of Changes
Other Study ID Numbers: GCF-016
Study First Received: December 1, 2010
Last Updated: March 28, 2013
Health Authority: Armenia: Ministry of Health

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
surgery
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014