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Clinical Trials/NCT01252862
NCT01252862CompletedPhase 4

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

Glaukos Corporation2 sites in 1 country40 target enrollmentStarted: December 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Two iStents devices

Experimental

Two iStents devices will be implanted

Intervention: iStent (Device)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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