Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE September 28, 2011
First Posted Date  ICMJE September 30, 2011
Last Update Posted Date December 18, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2011)
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01444040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • Change in mean diurnal IOP vs. screening [ Time Frame: Month 24 ]
  • Change in screening in time-wise IOPs [ Time Frame: Various Month 12-60 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2012)
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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%
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Open-angle Glaucoma
Intervention  ICMJE
  • Device: iStent inject
    Implantation of two iStent inject devices
  • Drug: Travoprost
    Travoprost drops
Study Arms  ICMJE
  • Active Comparator: iStent inject
    Implantation of two iStent inject devices
    Intervention: Device: iStent inject
  • Active Comparator: Drug
    Travoprost drops
    Intervention: Drug: Travoprost
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2012)
200
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2011)
100
Estimated Study Completion Date  ICMJE June 2018
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Armenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01444040
Other Study ID Numbers  ICMJE GCF-027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glaukos Corporation
Study Sponsor  ICMJE Glaukos Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lilit A Voskanyan, MD, PhD S.V. Malayan Ophthalmological Center, Yerevan, Armenia
PRS Account Glaukos Corporation
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP