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Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01155323
First received: June 30, 2010
Last updated: August 16, 2013
Last verified: August 2013
Results First Received: August 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: etafilcon A
Device: omafilcon 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
No text entered.

Reporting Groups
  Description
Etafilcon A/Omafilcon A etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
Omafilcon A/Etafilcon A omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.

Participant Flow for 2 periods

Period 1:   First Intervention
    Etafilcon A/Omafilcon A     Omafilcon A/Etafilcon A  
STARTED     60     58  
COMPLETED     59     57  
NOT COMPLETED     1     1  
exclusion criteria                 1                 1  

Period 2:   Second Intervention
    Etafilcon A/Omafilcon A     Omafilcon A/Etafilcon A  
STARTED     59     57  
COMPLETED     58     56  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  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
Total Number of Participants This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.

Baseline Measures
    Total Number of Participants  
Number of Participants  
[units: participants]
  113  
Age  
[units: years]
Mean ± Standard Deviation
  25.3  ± 4.4  
Gender  
[units: participants]
 
Female     80  
Male     33  
Region of Enrollment  
[units: participants]
 
Singapore     113  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjective Rating of Comfort   [ Time Frame: after 1 week of lens wear ]

2.  Primary:   Vision Quality   [ Time Frame: after 1 week of lens wear ]

3.  Primary:   Subjective Rating of Handling   [ Time Frame: after 1 week of lens wear ]

4.  Primary:   Corneal Staining   [ Time Frame: after 1 week of lens wear ]

5.  Primary:   Subjective Rating of Quality Perceptions   [ Time Frame: after 1 week of lens wear ]

6.  Primary:   Limbal Hyperemia   [ Time Frame: after 1 week of 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
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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: Wakana Katabami
Organization: Johnson and Johnson K.K.
phone: 81-34411-8040 ext 22025
e-mail: wkatabam@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01155323     History of Changes
Other Study ID Numbers: CR-0926, DISP-523
Study First Received: June 30, 2010
Results First Received: August 29, 2011
Last Updated: August 16, 2013
Health Authority: Singapore: independent review board