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Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)

Primary Purpose

Eye Diseases, Glaucoma, Open-Angle, Glaucoma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
iStent
latanoprost/timolol
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Diseases focused on measuring primary open angle glaucoma (POAG), OAG, glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma
  • Male or female at least 18 years of age and able to provide written informed consent
  • Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
  • Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

  • Angle closure glaucoma
  • Secondary glaucomas
  • Prior glaucoma procedures
  • Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Sites / Locations

  • SV Malayan Ophthalmological Center
  • Allgemeines Krankenhaus Wien
  • CHU de Lyon Hopital Edouard Herriot
  • CHNO des Quinze-Vingts
  • Knapschaftskrankenhaus Bochum Langendreer
  • Helios Cliniic
  • Universitatsklinkum Erlangen
  • AHEPA Hospital
  • Universita'degli Studi di Parma
  • Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
  • Azienda Ospedaliera S. Maria della Misericordia
  • Military Health Service Institute
  • Hospital Torrevieja Salud, UTE
  • Hospital Clinico San Carlos
  • Hospital Universitario Miguel Servet
  • Hinchingbrooke Hospital Moorfields

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stent

Medication

Arm Description

One hundred patients will be randomized to implantation of two G2 stents in at least one eye.

One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.

Outcomes

Primary Outcome Measures

Mean intraocular pressure (IOP)

Secondary Outcome Measures

Full Information

First Posted
June 1, 2009
Last Updated
May 18, 2015
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00913029
Brief Title
Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)
Acronym
SL
Official Title
A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Detailed Description
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases, Glaucoma, Open-Angle, Glaucoma
Keywords
primary open angle glaucoma (POAG), OAG, glaucoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Active Comparator
Arm Description
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
Arm Title
Medication
Arm Type
Active Comparator
Arm Description
One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.
Intervention Type
Device
Intervention Name(s)
iStent
Other Intervention Name(s)
stent, Trabecular micro bypass
Intervention Description
iStent
Intervention Type
Drug
Intervention Name(s)
latanoprost/timolol
Intervention Description
Combination latanoprost/timolol
Primary Outcome Measure Information:
Title
Mean intraocular pressure (IOP)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary open-angle glaucoma Male or female at least 18 years of age and able to provide written informed consent Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg Likely to be available and willing to attend follow-up visits Exclusion Criteria: Angle closure glaucoma Secondary glaucomas Prior glaucoma procedures Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Wells, PharmD, MBA
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
SV Malayan Ophthalmological Center
City
Yerevan
Country
Armenia
Facility Name
Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
CHU de Lyon Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHNO des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Knapschaftskrankenhaus Bochum Langendreer
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Helios Cliniic
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitatsklinkum Erlangen
City
Erlangen
Country
Germany
Facility Name
AHEPA Hospital
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Universita'degli Studi di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Military Health Service Institute
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Hospital Torrevieja Salud, UTE
City
Alicante
ZIP/Postal Code
03186
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Hinchingbrooke Hospital Moorfields
City
Bedford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24855336
Citation
Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.
Results Reference
result

Learn more about this trial

Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)

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