Status:

COMPLETED

Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost

Lead Sponsor:

Glaukos Corporation

Conditions:

Open-angle Glaucoma

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hy...

Detailed Description

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hy...

Eligibility Criteria

Inclusion

  • Phakic study eye
  • IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening)

Exclusion

  • Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
  • Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Key Trial Info

Start Date :

September 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2017

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT01443988

Start Date

September 1 2011

End Date

April 1 2017

Last Update

December 18 2017

Active Locations (1)

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1

S.V. Malayan Ophthalmological Center

Yerevan, Armenia, 0001