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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):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT00708032
First received: June 27, 2008
Last updated: May 5, 2015
Last verified: May 2015
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   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.
There were 74 subjects enrolled with 48 completing the study.

Reporting Groups
  Description
Spectacles spectacles worn daily for 12 months
Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months
Total Total of all reporting groups

Baseline Measures
   Spectacles   Narafilcon A Lenses   Total 
Overall Participants Analyzed 
[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
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1.  Primary:   Papillary Conjunctivitis   [ Time Frame: 12 months ]

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

3.  Secondary:   Visual Acuity After 12 Months of Wear   [ Time Frame: at 12 months ]

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

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


  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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