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Trial record 1 of 1 for:    NCT00334750
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Distribution of Risk Factors in Ocular Hypertension and Open-Angle Glaucoma Patients in Canada

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.
 
ClinicalTrials.gov Identifier: NCT00334750
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date June 5, 2006
First Posted Date June 8, 2006
Last Update Posted Date February 2, 2021
Study Start Date November 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2008)
To describe the presence and distribution of risk factors in subjects diagnosed with OH or OAG stratified according to geographic distribution in a Canadian population in the ophthalmologist practice. [ Time Frame: duration of study ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: January 14, 2008)
To describe the severity of disease at the time of diagnosis and to determine if there is a correlation between risk factors, or number of risk factors, and the severity of disease at presentation. [ Time Frame: duration of study ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Distribution of Risk Factors in Ocular Hypertension and Open-Angle Glaucoma Patients in Canada
Official Title Distribution of Risk Factors Amongst Ocular Hypertension and Open-Angle Glaucoma Patients in Canada
Brief Summary This descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in Canada.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Canadian population
Condition
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention Other: There is no intervention in this study.
This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada.
Study Groups/Cohorts There is no intervention in this study
This study is collecting information on the presence of risk factors in new diagnosed OH and OAG patients in Canada.
Intervention: Other: There is no intervention in this study.
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 Completed
Actual Enrollment
 (submitted: September 8, 2010)
410
Original Enrollment
 (submitted: June 5, 2006)
400
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects diagnosed at study visit or within 3 months of visit with OH
  • OAG (to include POAG, NTG, pigmentary and pseudoexfoliation glaucoma)

Exclusion Criteria:

  • No prior treatment for OH or OAG
  • No prior ocular surgery or history of ocular trauma
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00334750
Other Study ID Numbers A6111125
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2010