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Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01166659
First received: July 14, 2010
Last updated: September 8, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Condition Intervention
Primary Open Angle Glaucoma (POAG)
Device: CyPass Micro-Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Transcend Medical, Inc.:

Primary Outcome Measures:
  • Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline [ Time Frame: Baseline; Month 12 postoperative ] [ Designated as safety issue: No ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.


Secondary Outcome Measures:
  • Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication [ Time Frame: Month 12 postoperative ] [ Designated as safety issue: No ]
    Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.

  • Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline [ Time Frame: Baseline, Month 12 postoperative ] [ Designated as safety issue: No ]
    The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.


Enrollment: 65
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyPass Micro-Stent
Subjects receive the CyPass Micro-Stent
Device: CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.

  Eligibility

Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of POAG
  • Medicated IOP ≥ 21 and ≤ 35 mmHg
  • Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria:

  • Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
  • Use of oral hypotensive medication treatment for glaucoma
  • Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
  • Clinically significant ocular pathology other than POAG
  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: NCT01166659

Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
Study Chair: Vice President of Medical Affairs Transcend Medical, Inc.
  More Information

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01166659     History of Changes
Other Study ID Numbers: TMI-10-03 
Study First Received: July 14, 2010
Results First Received: August 25, 2016
Last Updated: September 8, 2016
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission
Bulgaria: Ministry of Health
Spain: Ethics Committee

Keywords provided by Transcend Medical, Inc.:
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

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

ClinicalTrials.gov processed this record on December 02, 2016