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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

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Armenia
Study Type
Interventional
Intervention
iStent
Travoprost
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • S.V. Malayan Ophthalmological Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

iStent

Drug

Arm Description

Implantation of two iStent devices

Travoprost drops

Outcomes

Primary Outcome Measures

Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2011
Last Updated
December 14, 2017
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01443988
Brief Title
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
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%
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
Keywords
Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iStent
Arm Type
Active Comparator
Arm Description
Implantation of two iStent devices
Arm Title
Drug
Arm Type
Active Comparator
Arm Description
Travoprost drops
Intervention Type
Device
Intervention Name(s)
iStent
Intervention Description
Implantation of two iStent devices
Intervention Type
Drug
Intervention Name(s)
Travoprost
Intervention Description
Travoprost drops
Primary Outcome Measure Information:
Title
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilit A Voskanyan, MD, PhD
Organizational Affiliation
S.V. Malayan Ophthalmological Center, Yerevan, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.V. Malayan Ophthalmological Center
City
Yerevan
ZIP/Postal Code
0001
Country
Armenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27619225
Citation
Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. doi: 10.1007/s40123-016-0065-3. Epub 2016 Sep 12. Erratum In: Ophthalmol Ther. 2016 Dec;5(2):173.
Results Reference
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Learn more about this trial

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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