Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00958828
First received: August 11, 2009
Last updated: June 26, 2012
Last verified: January 2012
Results First Received: September 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Nelfilcon A contact lens
Device: Narafilcon 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
No text entered.

Reporting Groups
  Description
Nelfilcon A / Narafilcon A Nelfilcon A contact lenses, then Narafilcon A contact lenses
Narafilcon A / Nelfilcon A Narafilcon A contact lenses, then Nelfilcon A contact lenses

Participant Flow for 2 periods

Period 1:   Period 1, 1 Week of Wear
    Nelfilcon A / Narafilcon A     Narafilcon A / Nelfilcon A  
STARTED     89     89  
COMPLETED     89     88  
NOT COMPLETED     0     1  
Randomization break                 0                 1  

Period 2:   Period 2, 1 Week of Wear
    Nelfilcon A / Narafilcon A     Narafilcon A / Nelfilcon A  
STARTED     89     88  
COMPLETED     89     87  
NOT COMPLETED     0     1  
Unacceptable lens fit                 0                 1  



  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]
  178  
Age  
[units: years]
Mean ± Standard Deviation
  30.0  ± 12.1  
Gender  
[units: participants]
 
Female     111  
Male     67  



  Outcome Measures

1.  Primary:   Overall Lens Satisfaction   [ 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
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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.


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: NCT00958828     History of Changes
Other Study ID Numbers: P-337-C-028
Study First Received: August 11, 2009
Results First Received: September 23, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board