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Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY (TEMPO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01467557
First received: October 26, 2011
Last updated: October 22, 2015
Last verified: October 2015
Results First Received: July 1, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Myopia
Hyperopia
Interventions: Device: narafilcon B daily disposable soft contact lenses
Device: etafilcon A daily disposable soft contact lenses

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1-Day ACUVUE TruEye Contact Lens Users

1-Day ACUVUE TruEye contact lens users

narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses

1-Day ACUVUE MOIST Contact Lens Users

1-Day ACUVUE MOIST contact lens users

etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses


Participant Flow:   Overall Study
    1-Day ACUVUE TruEye Contact Lens Users   1-Day ACUVUE MOIST Contact Lens Users
STARTED   601   570 
2 Week Survey Completed   551   522 
4 Month Survey Completed   533   493 
12 Month Survey Completed   502   463 
COMPLETED   502   463 
NOT COMPLETED   99   107 



  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
1-Day ACUVUE TruEye Contact Lens Users

1-Day ACUVUE TruEye contact lens users

narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses

1-Day ACUVUE MOIST Contact Lens Users

1-Day ACUVUE MOIST contact lens users

etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses

Total Total of all reporting groups

Baseline Measures
   1-Day ACUVUE TruEye Contact Lens Users   1-Day ACUVUE MOIST Contact Lens Users   Total 
Overall Participants Analyzed 
[Units: Participants]
 601   570   1171 
Age 
[Units: Participants]
     
<=18 years   106   121   227 
Between 18 and 65 years   484   445   929 
>=65 years   11   4   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.2  (13.9)   30.3  (12.9)   31.8  (13.5) 
Gender 
[Units: Participants]
     
Female   400   392   792 
Male   201   178   379 
Region of Enrollment 
[Units: Participants]
     
United States   601   570   1171 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Adverse Events   [ Time Frame: Self-report at 2 Week, 4 Month or 12 Month surveys ]

2.  Secondary:   Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys   [ Time Frame: Baseline, 2 Week, 4 Month or 12 Month surveys ]


  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: Jurandir Araujo
Organization: Vistakon
phone: +1 904 443-1379
e-mail: jaraujo7@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01467557     History of Changes
Other Study ID Numbers: CR-005059
Study First Received: October 26, 2011
Results First Received: July 1, 2015
Last Updated: October 22, 2015
Health Authority: United States: Institutional Review Board