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

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ClinicalTrials.gov Identifier: NCT01166659
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 28, 2016
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Transcend Medical, Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Open Angle Glaucoma (POAG) Device: CyPass Micro-Stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication [ Time Frame: Month 12 postoperative ]
    Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.

  2. Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline [ Time Frame: Baseline, Month 12 postoperative ]
    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.



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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166659


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

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01166659     History of Changes
Other Study ID Numbers: TMI-10-03
First Posted: July 21, 2010    Key Record Dates
Results First Posted: October 28, 2016
Last Update Posted: May 15, 2017
Last Verified: October 2016

Keywords provided by Alcon Research ( Transcend Medical, Inc. ):
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

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