Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01007916
First received: November 2, 2009
Last updated: June 26, 2012
Last verified: January 2012
Results First Received: January 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Lotrafilcon B contact lens
Device: Habitual contact lens

  Participant Flow
  Hide Participant Flow

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
One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups
  Description
Lotrafilcon B / Habitual Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Habitual / Lotrafilcon B Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Participant Flow for 2 periods

Period 1:   Period 1, 4 Weeks of Wear
    Lotrafilcon B / Habitual     Habitual / Lotrafilcon B  
STARTED     23     26  
COMPLETED     22     26  
NOT COMPLETED     1     0  
Failed inclusion/exclusion                 1                 0  

Period 2:   Period 2, 4 Weeks of Wear
    Lotrafilcon B / Habitual     Habitual / Lotrafilcon B  
STARTED     22     25 [1]
COMPLETED     21     25  
NOT COMPLETED     1     0  
Relocation                 1                 0  
[1] One participant completed Period 1 but did not start Period 2 due to failing inclusion criteria.



  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 Study This reporting group includes all enrolled and dispensed subjects

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  49  
Age  
[units: years]
Mean ± Standard Deviation
  30.4  ± 10.2  
Gender  
[units: participants]
 
Female     34  
Male     15  



  Outcome Measures

1.  Primary:   Comfort Upon Insertion   [ 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
Participants were masked to lotrafilcon B lenses only.


  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: NCT01007916     History of Changes
Other Study ID Numbers: P-336-C-016
Study First Received: November 2, 2009
Results First Received: January 31, 2011
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board