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Clinical Trials/NCT01517477
NCT01517477
Completed
Not Applicable

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

Glaukos Corporation1 site in 1 country119 target enrollmentJanuary 2012
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ConditionsPrimary Open Angle Glaucoma (POAG)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Open Angle Glaucoma (POAG)
Sponsor
Glaukos Corporation
Enrollment
119
Locations
1
Primary Endpoint
Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
October 18, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline

Time Frame: 12 Months

Secondary Outcomes

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

Study Sites (1)

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