Ocular Hypertension Clinical Trial
Official title:
A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.
NCT number | NCT00140049 |
Other study ID # | A6641038 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2005 |
Est. completion date | July 2006 |
Verified date | November 2007 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
Status | Completed |
Enrollment | 238 |
Est. completion date | July 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: - Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. - History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening |
Country | Name | City | State |
---|---|---|---|
France | Pfizer Investigational Site | Caen | |
France | Pfizer Investigational Site | Clermont-ferrand | |
France | Pfizer Investigational Site | Lyon | |
France | Pfizer Investigational Site | Marseille Cedex 05 | |
France | Pfizer Investigational Site | Saint Herblain | |
Germany | Pfizer Investigational Site | Darmstadt | |
Germany | Pfizer Investigational Site | Darmstadt | |
Germany | Pfizer Investigational Site | Landau / Pfalz | |
Germany | Pfizer Investigational Site | Regenstauf | |
Germany | Pfizer Investigational Site | Schorndorf | |
Germany | Pfizer Investigational Site | Starnberg | |
Greece | Pfizer Investigational Site | Alexandroupoli | |
Greece | Pfizer Investigational Site | Heraklion | Crete |
Greece | Pfizer Investigational Site | Larisa | |
Greece | Pfizer Investigational Site | Thessaloniki | Macedonia |
Italy | Pfizer Investigational Site | Chieti | |
Italy | Pfizer Investigational Site | Foggia | |
Italy | Pfizer Investigational Site | Genova | |
Italy | Pfizer Investigational Site | Milano | |
Italy | Pfizer Investigational Site | Monza (MI) | |
Italy | Pfizer Investigational Site | Pisa | |
Sweden | Pfizer Investigational Site | örebro | |
Sweden | Pfizer Investigational Site | Malmo | |
Sweden | Pfizer Investigational Site | Molndal | |
Sweden | Pfizer Investigational Site | Sundsvall |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
France, Germany, Greece, Italy, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean IOP measurements obtained in the study eye at each time point |
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