Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00708032
First received: June 27, 2008
Last updated: November 3, 2011
Last verified: November 2011
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Refractive Error
Myopia
Interventions: Device: spectacles
Device: narafilcon A soft contact lenses

  Participant Flow


  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
Habitual Spectacles habitual spectacles worn daily for 12 months
Narafilcon A Soft Contact Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months
Total Total of all reporting groups

Baseline Measures
    Habitual Spectacles     Narafilcon A Soft Contact Lenses     Total  
Number of Participants  
[units: participants]
  36     38     74  
Age  
[units: years]
Mean ± Standard Deviation
  26.5  ± 8.1     26.5  ± 7.4     26.5  ± 7.7  
Gender  
[units: participants]
     
Female     16     19     35  
Male     20     19     39  
Region of Enrollment  
[units: participants]
     
United Kingdom     36     38     74  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity After 12 Months of Wear   [ Time Frame: at 12 months ]

2.  Secondary:   Biomicroscopy Findings After 12 Months of Daily Wear   [ Time Frame: at 12 months ]

3.  Secondary:   Subjective Overall Comfort After 12 Months of Daily Wear   [ Time Frame: at 12 months ]

4.  Secondary:   Subjective Overall Vision After 12 Months of Daily Wear   [ Time Frame: at 12 months ]


  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
No text entered.  


Results Point of Contact:  
Name/Title: Kathy Osborn, OD
Organization: Johnson & Johnson Vision Care, Inc.
phone: +1 904 443-1032
e-mail: kosborn@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00708032     History of Changes
Other Study ID Numbers: CR-0806
Study First Received: June 27, 2008
Results First Received: November 3, 2011
Last Updated: November 3, 2011
Health Authority: United Kingdom: Research Ethics Committee