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OpenTrials
Completed

NCT Number: NCT01444040

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

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

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

S.V. Malayan Ophthalmological Center

Yerevan, 0001, Armenia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Phakic study eye
  • IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement

Exclusion criteria

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

Treatment and study plan

iStent inject

Device

Implantation of two iStent inject devices

Travoprost

Drug

Travoprost drops

Primary outcomes

  1. Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.

    Time frame: 12 months

Secondary outcomes

  1. Change in mean diurnal IOP vs. screening

    Time frame: Month 24

  2. Change in screening in time-wise IOPs

    Time frame: Various Month 12-60

  3. Proportion of responders

    Time frame: Various 12-60 months

    A responder is defined as a subject with a certain target IOP value or a certain reduction of IOP as compared to screening. In the iStent inject group, a responder must not be on an ocular hypotensive medications or have had a postoperative procedure to reposition or remove stent(s) prior to the visit. Due to the lack of a complete consensus on the definition of a clinical responder, a set of target IOP values (e.g., downwards from 22 mm Hg in steps of 1 mm Hg) and reductions of IOP (e.g., downwards from the highest reduction in IOP in steps of 5%) will be evaluated.

Other outcomes

  1. Adverse event reporting

    Time frame: 0-60 months

    Rate of ocular adverse events through 60 months

    • Findings from IOP, best corrected visual acuity, visual field
    • Findings from slit-lamp, fundus and gonioscopic examinations

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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 Inject) or Travoprost Ophthalmic Solution 0.004%

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2011
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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