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Evaluation of Lotrafilcon A Lenses Over a Three Month Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00931307
First received: July 1, 2009
Last updated: June 26, 2012
Last verified: October 2010
History of Changes
Results First Received: September 16, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myopia
Intervention: Device: Lotrafilcon A contact lens

  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
No text entered.

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
Lotrafilcon A Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner

Participant Flow:   Overall Study
    Lotrafilcon A  
STARTED     22  
COMPLETED     9  
NOT COMPLETED     13  
Lack of Efficacy                 12  
Biomicroscopy                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Lotrafilcon A Silicone hydrogel, spherical, soft contact lens

Baseline Measures
    Lotrafilcon A  
Number of Participants  
[units: participants]
 		  22  
Age  
[units: years]
Mean ± Standard Deviation 		  32.4  ± 10.0  
Gender  
[units: participants]
 		 
Female     16  
Male     6  



  Outcome Measures

1.  Primary:   Comfort After Insertion   [ Time Frame: 3 months ]
  Show Outcome Measure 1


  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
Due to the small number of subjects successfully completing this trial, the results should be interpreted with caution.  


Results Point of Contact:  
Name/Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization: CIBA VISION
phone: 1-800-241-7629
e-mail: priya.janakiraman@cibavision.com


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00931307     History of Changes
Other Study ID Numbers: P-335-C-013
Study First Received: July 1, 2009
Results First Received: September 16, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board