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Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00966940
First received: August 26, 2009
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: February 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN)
Drug: Tafluprost 0.0015% ophthalmic 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 four private practices located in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Travoprost-to-tafluprost Travoprost, then tafluprost
Tafluprost-to-travoprost Tafluprost, then travoprost

Participant Flow for 2 periods

 Period 1:   Period 1, First 6 Weeks
    Travoprost-to-tafluprost     Tafluprost-to-travoprost  
STARTED     28     23  
COMPLETED     25     23  
NOT COMPLETED     3     0  
Withdrawal by Subject                 2                 0  
Protocol Violation                 1                 0  

Period 2:   Period 2, Second 6 Weeks
    Travoprost-to-tafluprost     Tafluprost-to-travoprost  
STARTED     25     23  
COMPLETED     25     23  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Travoprost-to-tafluprost Travoprost, then tafluprost
Tafluprost-to-travoprost Tafluprost, then travoprost
Total Total of all reporting groups

Baseline Measures
    Travoprost-to-tafluprost     Tafluprost-to-travoprost     Total  
Number of Participants  
[units: participants]
 		  28     23     51  
Age  
[units: years]
Mean ± Standard Deviation 		  69.1  ± 7.8     68.5  ± 10.5     68.8  ± 9.0  
Gender  
[units: participants]
 		     
Female     16     15     31  
Male     12     8     20  



  Outcome Measures
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1.  Primary:   Mean Intraocular Pressure (IOP) at 8:00 PM   [ Time Frame: 6 weeks ]
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2.  Secondary:   Mean Intraocular Pressure (IOP) at 8:00 AM   [ Time Frame: 6 weeks ]
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3.  Secondary:   Mean Intraocular Pressure (IOP) at 10:00 AM   [ Time Frame: 6 weeks ]
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4.  Secondary:   Mean Intraocular Pressure (IOP) at 12:00 PM   [ Time Frame: 6 weeks ]
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5.  Secondary:   Mean Intraocular Pressure (IOP) at 2:00 PM   [ Time Frame: 6 weeks ]
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6.  Secondary:   Mean Intraocular Pressure (IOP) at 4:00 PM   [ Time Frame: 6 weeks ]
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7.  Secondary:   Mean Intraocular Pressure (IOP) at 6:00 PM   [ Time Frame: 6 weeks ]
  Show Outcome Measure 7


  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
No text entered.  


Results Point of Contact:  
Name/Title: Director of Medical Affairs
Organization: Alcon Research, Ltd.
phone: 1-800-862-5266
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00966940     History of Changes
Other Study ID Numbers: SMA-08-16
Study First Received: August 26, 2009
Results First Received: February 9, 2011
Last Updated: May 18, 2012
Health Authority: Germany: Ethics Commission