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Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01293240
First received: February 9, 2011
Last updated: June 26, 2012
Last verified: May 2012
History of Changes
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myopia
Astigmatism
Presbyopia
Intervention: Device: lotrafilcon B 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
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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 B Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.

Participant Flow:   Overall Study
    Lotrafilcon B  
STARTED     117  
COMPLETED     115  
NOT COMPLETED     2  
Noncompliance                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Lotrafilcon B Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.

Baseline Measures
    Lotrafilcon B  
Number of Participants  
[units: participants]
 		  117  
Age [1]
[units: years]
Mean ± Standard Deviation 		  45.8  ± 12.6  
Gender [2]
[units: participants]
 		 
Female     79  
Male     36  
[1] This reporting group includes 114 enrolled and dispensed participants - i.e., 117 total minus 3 missing responses.
[2] This reporting group includes 115 enrolled and dispensed participants - i.e., 117 total minus 2 missing responses.



  Outcome Measures
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1.  Primary:   Overall Comfort   [ Time Frame: 2 weeks ]
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2.  Primary:   Overall Comfort   [ Time Frame: 4 weeks ]
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3.  Primary:   End of Day Dryness   [ Time Frame: 2 weeks ]
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4.  Primary:   End of Day Dryness   [ Time Frame: 4 weeks ]
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5.  Primary:   Ocular Redness   [ Time Frame: 2 weeks ]
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6.  Primary:   Ocular Redness   [ Time Frame: 4 weeks ]
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7.  Primary:   Visual Clarity   [ Time Frame: 2 weeks ]
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8.  Primary:   Visual Clarity   [ Time Frame: 4 weeks ]
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9.  Primary:   Lens Deposits   [ Time Frame: 2 weeks ]
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10.  Primary:   Lens Deposits   [ Time Frame: 4 weeks ]
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11.  Primary:   Corrected Visual Acuity   [ Time Frame: 2 weeks ]
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12.  Primary:   Corrected Visual Acuity   [ Time Frame: 4 weeks ]
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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
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Results Point of Contact:  
Name/Title: Peter Bergenske
Organization: Alcon Research
phone: 1-800-241-7629


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01293240     History of Changes
Other Study ID Numbers: P-368-C-400
Study First Received: February 9, 2011
Results First Received: May 1, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board