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

Sponsor

Glaukos Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00913029

Collaborator

(none)

192

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases Glaucoma, Open-Angle Glaucoma	Device: iStent Drug: latanoprost/timolol	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stent One hundred patients will be randomized to implantation of two G2 stents in at least one eye.	Device: iStent iStent Other Names: stent, Trabecular micro bypass
Active Comparator: Medication One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.	Drug: latanoprost/timolol Combination latanoprost/timolol

Arm

Intervention/Treatment

Active Comparator: Stent

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

Device: iStent

iStent

Other Names:

stent, Trabecular micro bypass

Active Comparator: Medication

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

Drug: latanoprost/timolol

Combination latanoprost/timolol

Outcome Measures

Primary Outcome Measures

Mean intraocular pressure (IOP) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	SV Malayan Ophthalmological Center	Yerevan	Armenia
2	Allgemeines Krankenhaus Wien	Wien	Austria	1090
3	CHU de Lyon Hopital Edouard Herriot	Lyon	France	69437
4	CHNO des Quinze-Vingts	Paris	France	75012
5	Knapschaftskrankenhaus Bochum Langendreer	Bochum	Germany	44892
6	Helios Cliniic	Erfurt	Germany	99089
7	Universitatsklinkum Erlangen	Erlangen	Germany
8	AHEPA Hospital	Thessaloniki	Greece	546 36
9	Universita'degli Studi di Parma	Parma	Italy	43100
10	Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica	Torino	Italy	10128
11	Azienda Ospedaliera S. Maria della Misericordia	Udine	Italy	33100
12	Military Health Service Institute	Warsaw	Poland	00-909
13	Hospital Torrevieja Salud, UTE	Alicante	Spain	03186
14	Hospital Clinico San Carlos	Madrid	Spain	28040
15	Hospital Universitario Miguel Servet	Zaragoza	Spain
16	Hinchingbrooke Hospital Moorfields	Bedford	United Kingdom