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Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

This study has been terminated.
(Question raised by Ethics Committee)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00471068
First received: May 8, 2007
Last updated: April 7, 2012
Last verified: February 2010
Results First Received: October 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Open-angle Glaucoma
Ocular Hypertension
Interventions: Drug: Travatan
Drug: Cosopt
Drug: Placebo (Timolol Vehicle)

  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
Recruitment period: from 13-03-2007 to 30-11-2007 Recruitment restarted on 27-03-2008 to 27-05-2008 First patient first visit: 19-03-2007 Last patient last visit: 29-05-2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After completing the run-in, 8 patients were not randomized: 7 patients did not meet entry criteria and 1 patient was excluded by sponsor’s decision.

Reporting Groups
  Description
Travatan No text entered.
Cosopt No text entered.

Participant Flow:   Overall Study
    Travatan     Cosopt  
STARTED     21     25  
COMPLETED     20     24  
NOT COMPLETED     1     1  



  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
Travatan No text entered.
Cosopt No text entered.
Total Total of all reporting groups

Baseline Measures
    Travatan     Cosopt     Total  
Number of Participants  
[units: participants]
  21     25     46  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     16     26  
>=65 years     11     9     20  
Gender  
[units: participants]
     
Female     14     10     24  
Male     7     15     22  



  Outcome Measures

1.  Primary:   Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment   [ Time Frame: At week 0 and week 6 ]


  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
Sample size smaller than the one defined by the protocol


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Labs
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00471068     History of Changes
Other Study ID Numbers: EMD-05-03
Study First Received: May 8, 2007
Results First Received: October 21, 2009
Last Updated: April 7, 2012
Health Authority: Infarmed:Portugal