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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00140049
First received: August 29, 2005
Last updated: November 29, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Glaucoma, Open Angle
Ocular Hypertension
Drug: Xalacom
Drug: Cosopt
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The mean IOP measurements obtained in the study eye at each time point

Estimated Enrollment: 238
Study Start Date: July 2005
Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140049

Locations
France
Pfizer Investigational Site
Caen, France, 14033
Pfizer Investigational Site
Clermont-ferrand, France, 63003
Pfizer Investigational Site
Lyon, France, 69437
Pfizer Investigational Site
Marseille Cedex 05, France, 13385
Pfizer Investigational Site
Saint Herblain, France, 44800
Germany
Pfizer Investigational Site
Darmstadt, Germany, 64283
Pfizer Investigational Site
Darmstadt, Germany, 64297
Pfizer Investigational Site
Landau / Pfalz, Germany, 76829
Pfizer Investigational Site
Regenstauf, Germany, 93128
Pfizer Investigational Site
Schorndorf, Germany, 73614
Pfizer Investigational Site
Starnberg, Germany, 82319
Greece
Pfizer Investigational Site
Heraklion, Crete, Greece, 71110
Pfizer Investigational Site
Thessaloniki, Macedonia, Greece, 546 36
Pfizer Investigational Site
Alexandroupoli, Greece, 68100
Pfizer Investigational Site
Larisa, Greece, 41110
Italy
Pfizer Investigational Site
Chieti, Italy, 66013
Pfizer Investigational Site
Foggia, Italy, 71100
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Milano, Italy, 20132
Pfizer Investigational Site
Monza (MI), Italy, 20052
Pfizer Investigational Site
Pisa, Italy, 56126
Sweden
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Molndal, Sweden, 431 80
Pfizer Investigational Site
Sundsvall, Sweden, 851 86
Pfizer Investigational Site
örebro, Sweden, 703 61
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140049     History of Changes
Other Study ID Numbers: A6641038
Study First Received: August 29, 2005
Last Updated: November 29, 2007
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014