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Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborators:
Singapore Polytechnic University
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01163760
First received: September 29, 2008
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: October 1, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Refractive Error
Interventions: Device: etafilcon A
Device: ocufilcon D

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 50 subjects enrolled in this single site study, located at Singapore University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 50 patients enrolled and randomized, and 50 patients completed the study.

Reporting Groups
  Description
Etafilcon A First, Then Ocufilcon D etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
Ocufilcon D First, Then Etafilcon A ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
Etafilcon A First, Then Etafilcon A etafilcon A contact lenses worn for both periods.
Ocufilcon D First, Then Ocufilcon D Ocufilcon D contact lenses worn for both periods.

Participant Flow for 4 periods

Period 1:   Period 1 (Fit)
    Etafilcon A First, Then Ocufilcon D     Ocufilcon D First, Then Etafilcon A     Etafilcon A First, Then Etafilcon A     Ocufilcon D First, Then Ocufilcon D  
STARTED     12     13     13     12  
COMPLETED     12     13     13     12  
NOT COMPLETED     0     0     0     0  

Period 2:   Period 2 (Follow-up)
    Etafilcon A First, Then Ocufilcon D     Ocufilcon D First, Then Etafilcon A     Etafilcon A First, Then Etafilcon A     Ocufilcon D First, Then Ocufilcon D  
STARTED     12     13     13     12  
COMPLETED     12     13     13     12  
NOT COMPLETED     0     0     0     0  

Period 3:   Period 3 (Fit)
    Etafilcon A First, Then Ocufilcon D     Ocufilcon D First, Then Etafilcon A     Etafilcon A First, Then Etafilcon A     Ocufilcon D First, Then Ocufilcon D  
STARTED     12     13     13     12  
COMPLETED     12     13     13     12  
NOT COMPLETED     0     0     0     0  

Period 4:   Period 4 (Follow-up)
    Etafilcon A First, Then Ocufilcon D     Ocufilcon D First, Then Etafilcon A     Etafilcon A First, Then Etafilcon A     Ocufilcon D First, Then Ocufilcon D  
STARTED     12     13     13     12  
COMPLETED     12     13     13     12  
NOT COMPLETED     0     0     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.
No text entered.

Reporting Groups
  Description
Overall Total number of completed participants are included in baseline measurements.

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean ± Standard Deviation
  25.0  ± 4.8  
Gender  
[units: participants]
 
Female     31  
Male     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lens Comfort   [ Time Frame: 1-week follow-up ]

2.  Secondary:   Comfort Throughout the Whole Day   [ Time Frame: 1-week follow-up ]

3.  Other Pre-specified:   Comfort While Working on Computer   [ Time Frame: 1-week-follow-up ]


  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
The integrity of the subject reported data is suspect and not reflective of lens’ performance due to a significant protocol deviation. Upon completion of the study it was found that subjects were unmasked and their data should be considered biased.


  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: Kurt Moody OD, FAAO
Organization: Vistakon
phone: 904-443-3088


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01163760     History of Changes
Other Study ID Numbers: CR-0706, PRO-518
Study First Received: September 29, 2008
Results First Received: October 1, 2008
Last Updated: October 28, 2014
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)