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

Glaucoma Clinical Trial

— SL  

Official title:

A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913029
• Other study ID #: Second Line
• Secondary ID: Second Line Tria
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: May 18, 2015
• Start date: May 2009
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteePoland: Ministry of HealthGreece: Ethics CommitteeAustria: EthikkommissionGermany: Ethics CommissionSpain: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• iStent
iStent

Drug:
• latanoprost/timolol
Combination latanoprost/timolol

Locations

Country	Name	City	State
Armenia	SV Malayan Ophthalmological Center	Yerevan
Austria	Allgemeines Krankenhaus Wien	Wien
France	CHU de Lyon Hopital Edouard Herriot	Lyon
France	CHNO des Quinze-Vingts	Paris
Germany	Knapschaftskrankenhaus Bochum Langendreer	Bochum
Germany	Helios Cliniic	Erfurt
Germany	Universitatsklinkum Erlangen	Erlangen
Greece	AHEPA Hospital	Thessaloniki
Italy	Universita'degli Studi di Parma	Parma
Italy	Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica	Torino
Italy	Azienda Ospedaliera S. Maria della Misericordia	Udine
Poland	Military Health Service Institute	Warsaw
Spain	Hospital Torrevieja Salud, UTE	Alicante
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	Hinchingbrooke Hospital Moorfields	Bedford

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Armenia,  Austria,  France,  Germany,  Greece,  Italy,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

Fea AM, Belda JI, Rekas M, Jünemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean intraocular pressure (IOP)		1 year	No