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A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

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ClinicalTrials.gov Identifier: NCT00277498
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Xalacom Drug: Xalatan Drug: Timolol Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension In The United States.
Study Start Date : December 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Timolol




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00277498


  Show 64 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00277498     History of Changes
Other Study ID Numbers: A6641044
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: June 2008

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents