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Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

This study has been completed.
Sponsor:
Collaborator:
Foresight Regulatory Strategies, Inc.
Information provided by:
Vistakon
ClinicalTrials.gov Identifier:
NCT00584220
First received: December 20, 2007
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: August 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Astigmatism
Interventions: Device: senofilcon A toric
Device: alphafilcon A toric

  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
Of those 96 enrolled subjects in the study, 7 did not meet the study eligibility criteria and 1 did not receive the study lenses. One enrolled subject was discontinued from the study leaving n=87 who completed the study.

Reporting Groups
  Description
Senofilcon A / Alphafilcon A senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
Alphafilcon A / Senofilcon A alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second

Participant Flow for 2 periods

Period 1:   First Period
    Senofilcon A / Alphafilcon A     Alphafilcon A / Senofilcon A  
STARTED     48     39  
COMPLETED     48     39  
NOT COMPLETED     0     0  

Period 2:   Second Period
    Senofilcon A / Alphafilcon A     Alphafilcon A / Senofilcon A  
STARTED     48     39  
COMPLETED     48     39  
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.
Baseline summary was conducted on enrolled subjects who completed the study.

Reporting Groups
  Description
All Subjects Subjects who enrolled and completed the study.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  87  
Age  
[units: years]
Mean ± Standard Deviation
  28.0  ± 5.98  
Gender  
[units: participants]
 
Female     51  
Male     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjective Reported Vision   [ Time Frame: 1 week ]

2.  Primary:   Subject Reported Lens Comfort.   [ Time Frame: 1 week ]


  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: Kurt Moody, OD, FAAO
Organization: Vistakon
phone: 904-443-3088
e-mail: kmoody1@its.jnj.com


No publications provided


Responsible Party: Kurt Moody, OD, FAAO./ Manager, Clinical Research, Vistakon
ClinicalTrials.gov Identifier: NCT00584220     History of Changes
Other Study ID Numbers: CR-0714B
Study First Received: December 20, 2007
Results First Received: August 21, 2009
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board