Trial record 14 of 1141 for:
"Glaucoma"
Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)
This study has been completed.
Sponsor:
Glaukos Corporation
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00913029
First received: June 1, 2009
Last updated: May 18, 2015
Last verified: May 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Eye Diseases Glaucoma, Open-Angle Glaucoma |
Device: iStent Drug: latanoprost/timolol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Glaukos Corporation:
Primary Outcome Measures:
- Mean intraocular pressure (IOP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 192 |
| Study Start Date: | May 2009 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
|
Device: iStent
iStent
Other Name: 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
|
Detailed Description:
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913029
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913029
Locations
| Armenia | |
| SV Malayan Ophthalmological Center | |
| Yerevan, Armenia | |
| Austria | |
| Allgemeines Krankenhaus Wien | |
| Wien, Austria, 1090 | |
| France | |
| CHU de Lyon Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| CHNO des Quinze-Vingts | |
| Paris, France, 75012 | |
| Germany | |
| Knapschaftskrankenhaus Bochum Langendreer | |
| Bochum, Germany, 44892 | |
| Helios Cliniic | |
| Erfurt, Germany, 99089 | |
| Universitatsklinkum Erlangen | |
| Erlangen, Germany | |
| Greece | |
| AHEPA Hospital | |
| Thessaloniki, Greece, 546 36 | |
| Italy | |
| Universita'degli Studi di Parma | |
| Parma, Italy, 43100 | |
| Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica | |
| Torino, Italy, 10128 | |
| Azienda Ospedaliera S. Maria della Misericordia | |
| Udine, Italy, 33100 | |
| Poland | |
| Military Health Service Institute | |
| Warsaw, Poland, 00-909 | |
| Spain | |
| Hospital Torrevieja Salud, UTE | |
| Alicante, Spain, 03186 | |
| Hospital Clinico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Universitario Miguel Servet | |
| Zaragoza, Spain | |
| United Kingdom | |
| Hinchingbrooke Hospital Moorfields | |
| Bedford, United Kingdom | |
Sponsors and Collaborators
Glaukos Corporation
Investigators
| Study Director: | Jeff Wells, PharmD, MBA | Glaukos Corporation |
More Information
Publications:
| Responsible Party: | Glaukos Corporation |
| ClinicalTrials.gov Identifier: | NCT00913029 History of Changes |
| Other Study ID Numbers: | Second Line Second Line Trial |
| Study First Received: | June 1, 2009 |
| Last Updated: | May 18, 2015 |
| Health Authority: | Italy: Ethics Committee Poland: Ministry of Health Greece: Ethics Committee Austria: Ethikkommission Germany: Ethics Commission Spain: Ethics Committee France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Glaukos Corporation:
|
primary open angle glaucoma (POAG) OAG glaucoma |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Eye Diseases Ocular Hypertension Latanoprost Antihypertensive Agents Timolol |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on September 30, 2016