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

Condition(s) targeted: Glaucoma, Open Angle; Ocular Hypertension

Intervention: Xalacom (Drug); Cosopt (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The mean IOP measurements obtained in the study eye at each time point

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, Lyon 69437, France

Pfizer Investigational Site, Clermont-ferrand 63003, France

Pfizer Investigational Site, Marseille Cedex 05 13385, France

Pfizer Investigational Site, SAINT HERBLAIN 44800, France

Pfizer Investigational Site, Caen 14033, France

Pfizer Investigational Site, Starnberg 82319, Germany

Pfizer Investigational Site, Regenstauf 93128, Germany

Pfizer Investigational Site, Schorndorf 73614, Germany

Pfizer Investigational Site, Darmstadt 64297, Germany

Pfizer Investigational Site, Landau / Pfalz 76829, Germany

Pfizer Investigational Site, Darmstadt 64283, Germany

Pfizer Investigational Site, Alexandroupoli 68100, Greece

Pfizer Investigational Site, Larisa 41110, Greece

Pfizer Investigational Site, Chieti 66013, Italy

Pfizer Investigational Site, Pisa 56126, Italy

Pfizer Investigational Site, Milano 20132, Italy

Pfizer Investigational Site, Genova 16132, Italy

Pfizer Investigational Site, Monza (MI) 20052, Italy

Pfizer Investigational Site, Foggia 71100, Italy

Pfizer Investigational Site, Molndal 431 80, Sweden

Pfizer Investigational Site, Malmo 205 02, Sweden

Pfizer Investigational Site, örebro 703 61, Sweden

Pfizer Investigational Site, Sundsvall 851 86, Sweden

Pfizer Investigational Site, Heraklion, Crete 71110, Greece

Pfizer Investigational Site, Thessaloniki, Macedonia 546 36, Greece

Starting date: July 2005
Ending date: July 2006
Last updated: November 29, 2007