Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01669629
First received: August 16, 2012
Last updated: May 5, 2014
Last verified: May 2014
Results First Received: December 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Myopia
Interventions: Device: delefilcon A
Device: etafilcon A

  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
There were 183 subjects enrolled with 183 subjects randomized.

Reporting Groups
  Description
Delefilcon A \ Etafilcon A

6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear

delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.

etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.

Etafilcon A \ Delefilcon A

6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear

delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.

etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.


Participant Flow for 2 periods

Period 1:   Period 1
    Delefilcon A \ Etafilcon A     Etafilcon A \ Delefilcon A  
STARTED     92     91  
COMPLETED     91     89  
NOT COMPLETED     1     2  
protocol deviation                 1                 2  

Period 2:   Period 2
    Delefilcon A \ Etafilcon A     Etafilcon A \ Delefilcon A  
STARTED     91     89  
COMPLETED     91     89  
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.
All enrolled subjects.

Reporting Groups
  Description
All Subjects All subjects who were enrolled in the study.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  183  
Age  
[units: years]
Mean ± Standard Deviation
  31.61  ± 7.061  
Gender  
[units: participants]
 
Female     125  
Male     58  
Region of Enrollment  
[units: participants]
 
United States     183  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subject Reported Ease of Removal   [ Time Frame: 6-10 Days ]

2.  Secondary:   Subject Reported Overall Comfort   [ Time Frame: 6-10 Days ]

3.  Secondary:   Subject Reported Overall Vision   [ Time Frame: 6-10 Days ]

4.  Secondary:   Binocular Snellen Visual Acuity   [ Time Frame: 6-10 Days ]

5.  Secondary:   Overall Corneal Staining   [ Time Frame: 6-10 Days ]


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist
Organization: Vistakon
phone: 904 443-1032
e-mail: kosborn@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01669629     History of Changes
Other Study ID Numbers: CR-005199
Study First Received: August 16, 2012
Results First Received: December 9, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration