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Clinical Trials/NCT01252862
NCT01252862
Completed
Phase 4

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents

Glaukos Corporation1 site in 1 country40 target enrollmentDecember 2010
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ConditionsSubjects With Primary Open-angle Glaucoma (POAG)

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Subjects With Primary Open-angle Glaucoma (POAG)
Sponsor
Glaukos Corporation
Enrollment
40
Locations
1
Primary Endpoint
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Detailed Description

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
December 2016
Last Updated
8 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)
  • •Subject on one topical hypotensive medication

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 12 Months

Secondary Outcomes

  • IOP < 18 mm Hg at Month 12(12 months)

Study Sites (1)

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