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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01444040
First received: September 28, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Open-angle Glaucoma
Device: iStent inject
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 Inject) or Travoprost Ophthalmic Solution 0.004%

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Change in mean diurnal IOP vs. screening [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Change in screening in time-wise IOPs [ Time Frame: Various Month 12-60 ] [ Designated as safety issue: No ]
  • Proportion of responders [ Time Frame: Various 12-60 months ] [ Designated as safety issue: No ]
    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:
  • Adverse event reporting [ Time Frame: 0-60 months ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 200
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 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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444040

Contacts
Contact: Jeff Wells, PharmD, MBA 949-367-9600 jwells@glaukos.com
Contact: Tim McCauley 949-367-9600 ext 248 timmccauley@glaukos.com

Locations
Armenia
S.V. Malayan Ophthalmological Center Recruiting
Yerevan, Armenia, 0001
Sub-Investigator: Leon Au, MD         
Sub-Investigator: Imran Masood, MD         
Sub-Investigator: Gerd Auffarth, MD, PhD         
Sub-Investigator: Iqbal Ahmed, MD         
Sub-Investigator: Steven Vold, MD         
Sub-Investigator: Anslem Juenemann, MD, PhD         
Sub-Investigator: Manfred Tetz, MD, PhD         
Sub-Investigator: Jose Belda, MD         
Sub-Investigator: Amadeu Carceller Guillamet, MD         
Sub-Investigator: Antonio Fea, MD, PhD         
Sub-Investigator: L. Jay Katz, MD         
Sub-Investigator: M Kahook, MD         
Sub-Investigator: Jeffrey Liebmann, MD         
Sub-Investigator: Jose Martinez de la Casa, MD         
Sub-Investigator: Yana Oganova, MD         
Sub-Investigator: Vahan Papoyan, MD         
Sub-Investigator: Levon Nersisyan, MD         
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: NCT01444040     History of Changes
Other Study ID Numbers: GCF-027
Study First Received: September 28, 2011
Last Updated: December 16, 2013
Health Authority: Armenia: 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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014