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A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00823043
First received: January 14, 2009
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
Results First Received: August 2, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Open-angle Glaucoma
Ocular Hypertension
Interventions: Drug: timolol hemihydrate
Drug: timolol maleate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Timolol Hemihydrate Timolol hemihydrate 0.5% ophthalmic solution.
Timolol Maleate in Sorbate Timolol maleate in sorbate 0.5% ophthalmic solution

Participant Flow:   Overall Study
    Timolol Hemihydrate     Timolol Maleate in Sorbate  
STARTED     64     39  
COMPLETED     64     39  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Total Subject Population All subjects responding to survey

Baseline Measures
    Total Subject Population  
Number of Participants  
[units: participants]
 		  103  
Age  
[units: years]
Mean ± Standard Deviation 		  70.7  ± 11.4  
Gender  
[units: participants]
 		 
Female     68  
Male     35  



  Outcome Measures
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1.  Primary:   Subject Reported Burning/Stinging   [ Time Frame: Upon instillation ]
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2.  Primary:   Subject Reported Tearing   [ Time Frame: Upon instillation. ]
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3.  Primary:   Subject Reported Light Sensitivity   [ Time Frame: Upon instillation ]
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4.  Primary:   Subject Reported Blurred Vision   [ Time Frame: Upon instillation ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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