Clinical trial NCT00140049: A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The mean IOP measurements obtained in the study eye at each time point
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Pfizer Investigational Site
city: Clermont-ferrand
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 05
country: France
facility: Pfizer Investigational Site
city: Saint Herblain
country: France
facility: Pfizer Investigational Site
city: Darmstadt
country: Germany
facility: Pfizer Investigational Site
city: Darmstadt
country: Germany
facility: Pfizer Investigational Site
city: Landau / Pfalz
country: Germany
facility: Pfizer Investigational Site
city: Regenstauf
country: Germany
facility: Pfizer Investigational Site
city: Schorndorf
country: Germany
facility: Pfizer Investigational Site
city: Starnberg
country: Germany
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
state: Macedonia
city: Alexandroupoli
country: Greece
facility: Pfizer Investigational Site
city: Larisa
country: Greece
facility: Pfizer Investigational Site
city: Chieti
country: Italy
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Monza (MI)
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Molndal
country: Sweden
facility: Pfizer Investigational Site
city: Sundsvall
country: Sweden
facility: Pfizer Investigational Site
city: Ã¶rebro
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: