Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01244893
First received: November 18, 2010
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: August 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Acuvue Advance Plus prePQ
Device: Acuvue Advance Plus postPQ

  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
4 investigation sites were used within the U.S. for this study, with a study duration of Oct 23, 2010 to Nov 7, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
44 subjects enrolled; 42 completed as cohort, two subjects were discontinued.

Reporting Groups
  Description
Acuvue Advance Plus preQ/Acuvue Advance Plus postQ

Arm 1:

Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.

Arm 2:

Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second.

Acuvue Advance Plus postQ/Acuvue Advance Plus preQ

Arm 1:

Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.

Arm 2:

Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second.


Participant Flow for 3 periods

Period 1:   Baseline
    Acuvue Advance Plus preQ/Acuvue Advance Plus postQ     Acuvue Advance Plus postQ/Acuvue Advance Plus preQ  
STARTED     22     22  
COMPLETED     22     21  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  

Period 2:   1-Week Follow Up
    Acuvue Advance Plus preQ/Acuvue Advance Plus postQ     Acuvue Advance Plus postQ/Acuvue Advance Plus preQ  
STARTED     22     21  
COMPLETED     21     21  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  

Period 3:   Final Visit
    Acuvue Advance Plus preQ/Acuvue Advance Plus postQ     Acuvue Advance Plus postQ/Acuvue Advance Plus preQ  
STARTED     21     21  
COMPLETED     21     21  
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.
44 persons enrolled, 42 completed as cohort, 2 dropped due to: 1 non-trial related adverse event, and 1 protocol deviation

Reporting Groups
  Description
All Subjects Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  44  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     44  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.3  ± 5.66  
Gender  
[units: participants]
 
Female     26  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity (VA)   [ Time Frame: 6-8 days after lens wear ]

2.  Secondary:   Corneal Staining   [ Time Frame: 6-8 days after lens wear ]

3.  Secondary:   Limbal Redness   [ Time Frame: 6-8 days after lens wear ]

4.  Secondary:   Bulbar Redness   [ Time Frame: 6-8 days after lens 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Brian Pall, O.D., M.S., F.A.A.O. Senior Research Optometrist
Organization: Johnson & Johnson Vision Care
phone: (904) 443-1290
e-mail: BPALL@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01244893     History of Changes
Other Study ID Numbers: CR-1636BI
Study First Received: November 18, 2010
Results First Received: August 29, 2013
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board