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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140049
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open Angle Ocular Hypertension Drug: Xalacom Drug: Cosopt Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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.
Study Start Date : July 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140049

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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
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
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
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
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's Upjohn has merged with Mylan to form Viatris Inc.
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Identifier: NCT00140049    
Other Study ID Numbers: A6641038
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: November 2007
Additional relevant MeSH terms:
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Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases