12-Month Stability of Diurnal IOP Control on Cosopt

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony D. Realini, West Virginia University
ClinicalTrials.gov Identifier:
NCT00379834
First received: September 21, 2006
Last updated: January 26, 2015
Last verified: January 2015
Results First Received: July 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Intervention: Drug: Cosopt

  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
10 subjects enrolled from WVU Eye Institute between April 2006 and April 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients excluded at any time

Reporting Groups
  Description
Cosopt Cosopt BID OU

Participant Flow:   Overall Study
    Cosopt  
STARTED     10  
COMPLETED     8  
NOT COMPLETED     2  
Time constraints                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cosopt Cosopt BID OU

Baseline Measures
    Cosopt  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     6  
Age  
[units: years]
Mean (Standard Deviation)
  58  (12)  
Gender  
[units: participants]
 
Female     7  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Diurnal Intraocular Pressure Control   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Tony Realini
Organization: West Virginia University
phone: 3045986926
e-mail: realinia@wvuhealthcare.com


No publications provided


Responsible Party: Anthony D. Realini, West Virginia University
ClinicalTrials.gov Identifier: NCT00379834     History of Changes
Other Study ID Numbers: 31861
Study First Received: September 21, 2006
Results First Received: July 25, 2013
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board