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Daily Disposable Toric Comparative Trial in Europe

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01070381
First received: February 16, 2010
Last updated: June 26, 2012
Last verified: January 2012
History of Changes
Results First Received: February 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myopia
Astigmatism
Interventions: Device: nelfilcon A contact lens
Device: ocufilcon D 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
Three participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups
  Description
Nelfilcon A / Ocufilcon D Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Ocufilcon D / Nelfilcon A Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Participant Flow for 2 periods

 Period 1:   Period 1, 1 Week of Wear
    Nelfilcon A / Ocufilcon D     Ocufilcon D / Nelfilcon A  
STARTED     109 [1]   107  
COMPLETED     109 [2]   107  
NOT COMPLETED     0     0  
[1] One subject could not be dispensed into Period 1 product. Subject started Period 2 wear.
[2] One subject could not continue into Period 2 due to product unavailability.

Period 2:   Period 2, 1 Week of Wear
    Nelfilcon A / Ocufilcon D     Ocufilcon D / Nelfilcon A  
STARTED     109     107  
COMPLETED     108     106  
NOT COMPLETED     1     1  
Handling                 0                 1  
Unacceptable Vision                 1                 0  



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

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
 		  217  
Age  
[units: years]
Mean ± Standard Deviation 		  33.2  ± 9.4  
Gender  
[units: participants]
 		 
Female     151  
Male     66  



  Outcome Measures

1.  Primary:   Overall Comfort   [ Time Frame: 1 week of wear ]
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Measure Type Primary
Measure Title Overall Comfort
Measure Description Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame 1 week of wear  
Safety Issue No  

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.
Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Reporting Groups
  Description
Nelfilcon A Commercially marketed, toric, soft contact lens for daily disposable wear
Ocufilcon D Commercially marketed, toric, soft contact lens for daily disposable wear

Measured Values
    Nelfilcon A     Ocufilcon D  
Number of Participants Analyzed  
[units: participants]
 		  213     213  
Overall Comfort  
[units: Units on a Scale]
Mean ± Standard Deviation 		  7.6  ± 1.9     7.6  ± 1.9  

No statistical analysis provided for Overall Comfort




  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: 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: NCT01070381     History of Changes
Other Study ID Numbers: P-346-C-008
Study First Received: February 16, 2010
Results First Received: February 25, 2011
Last Updated: June 26, 2012
Health Authority: Germany: Ethics Commission