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Efficacy Study of Travoprost APS Versus TRAVATAN

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00848536
First received: February 19, 2009
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
Results First Received: February 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Open Angle Glaucoma
Ocular Hypertension
Interventions: Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution

  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
Patients were recruited from 30 study centers: 8 in the US, 6 in Mexico, 2 in Brazil, 4 in India, 2 in Australia, 2 in New Zealand, 2 in Latvia, and a single site in each: Taiwan, France, Belgium, and Italy.

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
TRAVATAN APS One drop once daily in the evening for 3 months
TRAVATAN One drop once daily in the evening for 3 months

Participant Flow:   Overall Study
    TRAVATAN APS     TRAVATAN  
STARTED     185     186  
COMPLETED     181     179  
NOT COMPLETED     4     7  
Adverse Event                 2                 2  
Withdrawal by Subject                 0                 1  
Protocol Violation                 0                 1  
Noncompliance                 1                 0  
Inadequate Control of IOP                 1                 1  
Patient Moved                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
TRAVATAN APS One drop once daily in the evening for 3 months
TRAVATAN One drop once daily in the evening for 3 months
Total Total of all reporting groups

Baseline Measures
    TRAVATAN APS     TRAVATAN     Total  
Number of Participants  
[units: participants]
 		  185     186     371  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     94     109     203  
>=65 years     91     77     168  
Gender  
[units: participants]
 		     
Female     112     115     227  
Male     73     71     144  



  Outcome Measures
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1.  Primary:   Mean Intraocular Pressure at 9:00 am   [ Time Frame: 3 months (measured at 9:00 am) ]
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2.  Primary:   Mean Intraocular Pressure at 11:00 am   [ Time Frame: 3 months (measured at 11:00 am) ]
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3.  Primary:   Mean Intraocular Pressure at 4:00 pm   [ Time Frame: 3 months (measured at 4:00 pm) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Director Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937 or 817.568.6725


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00848536     History of Changes
Other Study ID Numbers: C-08-40, 2008-006027-31
Study First Received: February 19, 2009
Results First Received: February 14, 2011
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board