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Clinical Trials/NCT01252888
NCT01252888
Completed
Phase 4

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

Glaukos Corporation1 site in 1 country39 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
39
Locations
1
Primary Endpoint
mean diurnal 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 assess efficacy and safety of two iStents for the reduction of intraocular pressure associated 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
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 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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