Clinical Evaluation of a Silicone Hydrogel Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01016132
First received: November 17, 2009
Last updated: June 26, 2012
Last verified: September 2011
Results First Received: December 17, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Myopia
Intervention: Device: lotrafilcon 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
All Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.

Participant Flow:   Overall Study
    All Participants  
STARTED     152  
COMPLETED     151  
NOT COMPLETED     1  
Discomfort                 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
All Participants In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  152  
Age  
[units: years]
Mean ± Standard Deviation
  33.5  ± 10.9  
Gender  
[units: participants]
 
Female     97  
Male     55  



  Outcome Measures

1.  Primary:   Overall Preference   [ Time Frame: 4 weeks 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: NCT01016132     History of Changes
Other Study ID Numbers: P-019-C-055
Study First Received: November 17, 2009
Results First Received: December 17, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board