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NCT00140049 Clinical Trial

A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

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.

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date November 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xalacom

• Cosopt

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

France,  Germany,  Greece,  Italy,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary The mean IOP measurements obtained in the study eye at each time point
See also
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