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Trial record 1 of 1 for:    NCT00159653
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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: NCT00159653
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date October 10, 2012
Study Start Date  ICMJE July 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
The mean IOP measurements obtained in the study eye at each time point
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00159653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Xalacom
  • Drug: Xalatan
  • Drug: Timolol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2012)
500
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
528
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159653
Other Study ID Numbers  ICMJE A6641027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP