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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

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ClinicalTrials.gov Identifier: NCT01444040
Recruitment Status : Active, not recruiting
First Posted : September 30, 2011
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Device: iStent inject Drug: Travoprost Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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%
Study Start Date : September 2011
Primary Completion Date : May 1, 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Travoprost
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: iStent inject
Implantation of two iStent inject devices
Device: iStent inject
Implantation of two iStent inject devices
Active Comparator: Drug
Travoprost drops
Drug: Travoprost
Travoprost drops



Primary Outcome Measures :
  1. Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444040


Locations
Armenia
S.V. Malayan Ophthalmological Center
Yerevan, Armenia, 0001
Sponsors and Collaborators
Glaukos Corporation
Investigators
Principal Investigator: Lilit A Voskanyan, MD, PhD S.V. Malayan Ophthalmological Center, Yerevan, Armenia

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01444040     History of Changes
Other Study ID Numbers: GCF-027
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Glaukos Corporation:
Open angle glaucoma
POAG
Ocular hypertension
Pseudoexfoliative glaucoma
Naïve to treatment

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Antihypertensive Agents