NCT00913029

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2009

Typical duration for phase_4

Geographic Reach
9 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

June 1, 2009

Last Update Submit

May 18, 2015

Conditions

Eye DiseasesGlaucoma, Open-AngleGlaucoma

Keywords

primary open angle glaucoma (POAG)OAGglaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean intraocular pressure (IOP)

    1 year

Study Arms (2)

Stent

ACTIVE COMPARATOR

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

Device: iStent

Medication

ACTIVE COMPARATOR

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

Drug: latanoprost/timolol

Interventions

iStentDEVICE

iStent

Also known as: stent, Trabecular micro bypass
Stent
latanoprost/timololDRUG

Combination latanoprost/timolol

Medication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

SV Malayan Ophthalmological Center

Yerevan, Armenia

Location

Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

CHU de Lyon Hopital Edouard Herriot

Lyon, 69437, France

Location

CHNO des Quinze-Vingts

Paris, 75012, France

Location

Knapschaftskrankenhaus Bochum Langendreer

Bochum, 44892, Germany

Location

Helios Cliniic

Erfurt, 99089, Germany

Location

Universitatsklinkum Erlangen

Erlangen, Germany

Location

AHEPA Hospital

Thessaloniki, 546 36, Greece

Location

Universita'degli Studi di Parma

Parma, 43100, Italy

Location

Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica

Torino, 10128, Italy

Location

Azienda Ospedaliera S. Maria della Misericordia

Udine, 33100, Italy

Location

Military Health Service Institute

Warsaw, 00-909, Poland

Location

Hospital Torrevieja Salud, UTE

Alicante, 03186, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Hinchingbrooke Hospital Moorfields

Bedford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24855336RESULT

MeSH Terms

Conditions

Eye DiseasesGlaucoma, Open-AngleGlaucoma

Interventions

StentsLatanoprostTimolol

Condition Hierarchy (Ancestors)

Ocular Hypertension

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Jeff Wells, PharmD, MBA

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

ES(3)GB(1)AU(1)GR(1)PL(1)DE(3)AR(1)FR(2)IT(3)