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Comparison of Two New Silicone Hydrogel Multifocal Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00823615
First received: January 13, 2009
Last updated: June 26, 2012
Last verified: January 2012
Results First Received: September 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Presbyopia
Interventions: Device: Lotrafilcon B multifocal contact lens
Device: Senofilcon A multifocal 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
Two participants were enrolled but not dispensed due to failing inclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups
  Description
Lotrafilcon B / Senofilcon A Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
Senofilcon A / Lotrafilcon B Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.

Participant Flow for 2 periods

Period 1:   Period 1
    Lotrafilcon B / Senofilcon A     Senofilcon A / Lotrafilcon B  
STARTED     19     19  
COMPLETED     19     19  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Lotrafilcon B / Senofilcon A     Senofilcon A / Lotrafilcon B  
STARTED     19     19  
COMPLETED     16     17  
NOT COMPLETED     3     2  
Lost to Follow-up                 2                 0  
Time/Job Conflict                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall This reporting group includes all enrolled and dispensed subjects

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Mean ± Standard Deviation
  47.6  ± 4.7  
Gender  
[units: participants]
 
Female     30  
Male     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity   [ Time Frame: After 1 week of wear ]

2.  Primary:   Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity   [ Time Frame: After 1 week of wear ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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: NCT00823615     History of Changes
Other Study ID Numbers: P-319-C-005 sub 7
Study First Received: January 13, 2009
Results First Received: September 7, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board