Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01482819
First received: November 16, 2011
Last updated: April 28, 2015
Last verified: April 2015
Results First Received: January 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: galyfilcon A
Device: galyfilcon A plus
Device: lotrafilcon A
Device: polymacon
Other: spectacles

  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
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Reporting Groups
  Description
All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.

Participant Flow:   Overall Study
    All Subjects  
STARTED     21  
COMPLETED     19  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  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.
Subjects who were screened, gave consent, enrolled, and were randomized in the study.

Reporting Groups
  Description
All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean (Standard Deviation)
  23.7  (6.11)  
Gender  
[units: participants]
 
Female     15  
Male     6  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     5  
Multiple     16  
Region of Enrollment  
[units: participants]
 
Australia     21  



  Outcome Measures
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1.  Primary:   Corneal Swelling   [ Time Frame: after 8 hours of lens wear ]

2.  Primary:   Limbal Redness   [ Time Frame: after 8 hours of lens wear ]

3.  Primary:   Endothelia Blebs   [ Time Frame: after 20 minutes of 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
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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 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.
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: Daria Wicks, Senior Clinical Research Manager
Organization: Johnson & Johnson Vision Care
phone: 904-443-1391
e-mail: RA-ClnclStds@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01482819     History of Changes
Other Study ID Numbers: CR-005031
Study First Received: November 16, 2011
Results First Received: January 8, 2015
Last Updated: April 28, 2015
Health Authority: Australia: National Health and Medical Research Council