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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.
Verified March 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01444040
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 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:

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 ]

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
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: March 28, 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
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013