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

Overview

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.

Full Title of Study: “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%”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2017

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 hypertension naïve to medical and surgical therapy.

Interventions

  • Device: iStent
    • Implantation of two iStent devices
  • Drug: Travoprost
    • Travoprost drops

Arms, Groups and Cohorts

  • Active Comparator: iStent
    • Implantation of two iStent devices
  • Active Comparator: Drug
    • Travoprost drops

Clinical Trial Outcome Measures

Primary Measures

  • Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
    • Time Frame: 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Glaukos Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lilit A Voskanyan, MD, PhD, Principal Investigator, S.V. Malayan Ophthalmological Center, Yerevan, Armenia

References

Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. doi: 10.1007/s40123-016-0065-3. Epub 2016 Sep 12. Erratum In: Ophthalmol Ther. 2016 Dec;5(2):173.

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