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12-Month Stability of Diurnal IOP Control on Cosopt

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379834
First Posted: September 25, 2006
Last Update Posted: February 10, 2015
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.
Information provided by (Responsible Party):
Anthony D. Realini, West Virginia University
Results First Submitted: July 25, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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



Responsible Party: Anthony D. Realini, West Virginia University
ClinicalTrials.gov Identifier: NCT00379834     History of Changes
Other Study ID Numbers: 31861
First Submitted: September 21, 2006
First Posted: September 25, 2006
Results First Submitted: July 25, 2013
Results First Posted: February 10, 2015
Last Update Posted: February 10, 2015