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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)or Travoprost

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ClinicalTrials.gov Identifier: NCT01443988
Recruitment Status : Completed
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 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 Drug: Travoprost Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 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) or Travoprost Ophthalmic Solution 0.004%
Actual Study Start Date : September 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2017

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
Implantation of two iStent devices
Device: iStent
Implantation of two iStent 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 ]


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 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

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): NCT01443988


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

Publications:
Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01443988     History of Changes
Other Study ID Numbers: GCF-022
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