Trial | NCT01443988  Report issue

Title

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
A Prospective, Randomized Evaluation of 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 Ophthalmic Solution 0.004%

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    travoprost ...

  • Study Participants

    101
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 hypertension naïve to medical and surgical therapy.
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 hypertension naïve to medical and surgical therapy.
Study Started
Sep 30
2011
Primary Completion
Jan 31
2017
Study Completion
Apr 30
2017
Last Update
Dec 18
2017

Device iStent

Implantation of two iStent devices

Drug Travoprost

Travoprost drops

iStent Active Comparator

Implantation of two iStent devices

Drug Active Comparator

Travoprost drops

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
No Results Posted