Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)
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| ClinicalTrials.gov Identifier: NCT00913029 |
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Recruitment Status
:
Completed
First Posted
: June 3, 2009
Last Update Posted
: May 20, 2015
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Sponsor:
Glaukos Corporation
Information provided by (Responsible Party):
Glaukos Corporation
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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 |
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
| Study Type : | Interventional (Clinical Trial) |
| 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 2009 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | September 2012 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Early-onset glaucoma
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
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Device: iStent
iStent
Other Name: stent, Trabecular micro bypass
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Active Comparator: Medication
One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.
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Drug: latanoprost/timolol
Combination latanoprost/timolol
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Primary Outcome Measures
:
- Mean intraocular pressure (IOP) [ Time Frame: 1 year ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications of Results:
| Responsible Party: | Glaukos Corporation |
| ClinicalTrials.gov Identifier: | NCT00913029 History of Changes |
| Other Study ID Numbers: |
Second Line Second Line Trial ( Other Identifier: Glaukos ) |
| First Posted: | June 3, 2009 Key Record Dates |
| Last Update Posted: | May 20, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Glaukos Corporation:
|
primary open angle glaucoma (POAG) OAG glaucoma |
Additional relevant MeSH terms:
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Glaucoma Glaucoma, Open-Angle Eye Diseases Ocular Hypertension Timolol Latanoprost Antihypertensive Agents |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents |