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Adherence Assessment With Travalert Dosing Aid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00508469
First received: July 26, 2007
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
Results First Received: June 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Open-angle Glaucoma
Ocular Hypertension
Interventions: Drug: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)
Drug: Travoprost 0.004% eye drops
Drug: Timolol 0.05% eye drops
Device: Travalert Dosing Aid

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Travalert With Travoprost/Timolol Fixed Combination One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
Travalert With Travoprost and Timolol One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
Total Total of all reporting groups

Baseline Measures
    Travalert With Travoprost/Timolol Fixed Combination     Travalert With Travoprost and Timolol     Total  
Number of Participants  
[units: participants]
 		  43     42     85  
Age  
[units: years]
Mean ± Standard Deviation 		  63.8  ± 11.1     68.6  ± 11.8     66.2  ± 11.6  
Gender  
[units: participants]
 		     
Female     26     25     51  
Male     17     17     34  



  Outcome Measures

1.  Primary:   Adherence   [ Time Frame: 6 months ]
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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: Severine Durier, PharmD
Organization: Alcon France
phone: +33 1 47 10 48 43


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00508469     History of Changes
Other Study ID Numbers: EMD-06-03
Study First Received: July 26, 2007
Results First Received: June 8, 2012
Last Updated: June 8, 2012
Health Authority: Spain: Ethics Committee