Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Collaborators:
Singapore Polytechnic
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01163760
First received: September 29, 2008
Last updated: November 7, 2011
Last verified: November 2011
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
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/ Ocufilcon D etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
Ocufilcon D / Etafilcon A ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
Etafilcon A/ Etafilcon A etafilcon A contact lenses worn first and second period.
Oculfilcon D / Ocufilcon D ocufilcon D contact lenses worn first and second period.

Participant Flow for 2 periods

Period 1:   Period One
    Etafilcon A/ Ocufilcon D     Ocufilcon D / Etafilcon A     Etafilcon A/ Etafilcon A     Oculfilcon D / Ocufilcon D  
STARTED     12     13     13     12  
COMPLETED     12     13     13     12  
NOT COMPLETED     0     0     0     0  

Period 2:   Period Two
    Etafilcon A/ Ocufilcon D     Ocufilcon D / Etafilcon A     Etafilcon A/ Etafilcon A     Oculfilcon D / 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

1.  Primary:   Lens Comfort   [ Time Frame: Change from baseline to one week ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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: November 7, 2011
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)