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Pilot Dispensing Evaluation of a Plus Power Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01228591
First received: October 22, 2010
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hyperopia
Interventions: Device: Acuvue Advance Plus
Device: Acuvue Advance

  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
This is a 3 site, 3 visit, randomized, double-masked, bilateral crossover trial comparing Acuvue Advance to Acuvue Advance Plus lenses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 38 subjects enrolled, 2 were ineligible and not-randomized, 3 discontinued, and 33 completed as cohort.

Reporting Groups
  Description
Acuvue Advance Plus/ Acuvue Advance Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
Acuvue Advance/ Acuvue Advance Plus Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second

Participant Flow for 3 periods

Period 1:   Baseline
    Acuvue Advance Plus/ Acuvue Advance     Acuvue Advance/ Acuvue Advance Plus  
STARTED     18     18  
COMPLETED     17     16  
NOT COMPLETED     1     2  
Lack of Efficacy                 1                 2  

Period 2:   1-Week Follow-Up
    Acuvue Advance Plus/ Acuvue Advance     Acuvue Advance/ Acuvue Advance Plus  
STARTED     17     16  
COMPLETED     17     16  
NOT COMPLETED     0     0  

Period 3:   Final Visit
    Acuvue Advance Plus/ Acuvue Advance     Acuvue Advance/ Acuvue Advance Plus  
STARTED     17     16  
COMPLETED     17     16  
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 subjects who successfully completed the study. There were 38 subjects that started, 3 discontinued, and 2 were ineligible.

Reporting Groups
  Description
All Subjects Subjects who were randomized and successfully completed the study.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  33  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.8  ± 5.66  
Gender  
[units: participants]
 
Female     21  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity One Week After Lens Wear   [ Time Frame: 1 week ]

2.  Primary:   Visual Acuity at Time of Initial Fit   [ Time Frame: After 10-15 minutes of lens wear ]

3.  Secondary:   Contact Lens Comfort Using Contact Lens User Experience (CLUE)   [ Time Frame: 1 week ]

4.  Secondary:   Subject Reported Vision Using Contact Lens User Experience (CLUE).   [ Time Frame: 1 week ]

5.  Secondary:   Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)   [ Time Frame: Baseline ]

6.  Secondary:   Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)   [ Time Frame: Baseline ]


  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 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: Brian Pall, O.D., M.S., F.A.A.O. Principal Research Optometrist
Organization: Johnson & Johnson Vision Care
phone: 1 904 443-1290
e-mail: bpall@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01228591     History of Changes
Other Study ID Numbers: CR-1636BB
Study First Received: October 22, 2010
Results First Received: September 17, 2013
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board