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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01443988
First received: September 28, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Open-angle Glaucoma
 Device: iStent
Drug: Travoprost
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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%

Resource links provided by NLM:

Drug Information available for: Travoprost
U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iStent
Implantation of two iStent devices
 Device: iStent
Implantation of two iStent devices
Active Comparator: Drug
Travoprost drops
 Drug: Travoprost
Travoprost drops

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01443988     History of Changes
Other Study ID Numbers: GCF-022
Study First Received: September 28, 2011
Last Updated: March 28, 2013
Health Authority: Armenia: Armenian Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013