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Clinical Trials/NCT01517477
NCT01517477CompletedNot 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 Corporation2 sites in 1 country119 target enrollmentStarted: January 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
119
Locations
2
Primary Endpoint
Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

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 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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