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Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01371539
First received: June 9, 2011
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
Results First Received: June 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Myopia
Presbyopia
Interventions: Device: Lotrafilcon B contact lens
Device: Comfilcon 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
Participants were recruited and enrolled from 12 US private practices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five participants were enrolled, but not dispensed, due to failing inclusion/exclusion criteria (4) and unacceptable subjective vision (1). Baseline characteristics are presented on all enrolled and dispensed participants: 104.

Reporting Groups
  Description
Lotrafilcon B / Comfilcon A Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Comfilcon A / Lotrafilcon B Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.

Participant Flow for 2 periods

 Period 1:   Period One: One Week
    Lotrafilcon B / Comfilcon A     Comfilcon A / Lotrafilcon B  
STARTED     53     51  
COMPLETED     53     50  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  

Period 2:   Period Two: One Week
    Lotrafilcon B / Comfilcon A     Comfilcon A / Lotrafilcon B  
STARTED     53     50  
COMPLETED     53     47  
NOT COMPLETED     0     3  
Lost to Follow-up                 0                 1  
Unacceptable Objective Visual Acuity                 0                 1  
Time/job conflict                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Overall All enrolled and dispensed participants

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
 		  104  
Age  
[units: years]
Mean ± Standard Deviation 		  49.0  ± 6.3  
Gender  
[units: participants]
 		 
Female     76  
Male     28  
Region of Enrollment  
[units: participants]
 		 
United States     104  



  Outcome Measures
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1.  Primary:   Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity   [ Time Frame: 1 week ]
  Show Outcome Measure 1

2.  Primary:   Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity   [ Time Frame: 1 week ]
  Show Outcome Measure 2


  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: Stacie Cummings, O.D.
Organization: Alcon Research, Ltd.
phone: 1-800-241-7629


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01371539     History of Changes
Other Study ID Numbers: P-319-C-021
Study First Received: June 9, 2011
Results First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board