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Clinical Trials/NCT01252914
NCT01252914
Completed
Phase 4

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent

Glaukos Corporation1 site in 1 country80 target enrollmentDecember 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Subject With Primary Open-angle Glaucoma (POAG)
Sponsor
Glaukos Corporation
Enrollment
80
Locations
1
Primary Endpoint
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Detailed Description

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
December 16, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subjects on two topical hypotensive medications

Exclusion Criteria

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled

Outcomes

Primary Outcomes

Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline

Time Frame: 12 months

Secondary Outcomes

  • Mean diurnal Intraocular Pressure < 18 mmHg at month 12(12 months)

Study Sites (1)

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