Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00808834
First received: December 11, 2008
Last updated: June 26, 2012
Last verified: January 2012
Results First Received: June 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Lotrafilcon A contact lens
Device: Senofilcon 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
Senofilcon A / Lotrafilcon A Senofilcon A, followed by Lotrafilcon A
Lotrafilcon A / Senofilcon A Lotrafilcon A, followed by Senofilcon A

Participant Flow for 2 periods

Period 1:   Period 1
    Senofilcon A / Lotrafilcon A     Lotrafilcon A / Senofilcon A  
STARTED     97     99  
COMPLETED     97     99  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Senofilcon A / Lotrafilcon A     Lotrafilcon A / Senofilcon A  
STARTED     97     99  
COMPLETED     97     99  
NOT COMPLETED     0     0  



  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 exposed subjects.

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  196  
Age  
[units: years]
Mean ± Standard Deviation
  30.7  ± 12.9  
Gender  
[units: participants]
 
Female     141  
Male     55  
Region of Enrollment  
[units: participants]
 
United States     196  



  Outcome Measures

1.  Primary:   Comfort After Insertion   [ Time Frame: 30-60 seconds after initial insertion ]


  Serious Adverse Events


  Other Adverse Events


  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: NCT00808834     History of Changes
Other Study ID Numbers: P-335-C-008
Study First Received: December 11, 2008
Results First Received: June 18, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board