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

This study has been completed.
University of Manchester
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc. Identifier:
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 Blind (Subject);   Primary Purpose: Treatment
Conditions: Refractive Error
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
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 
[units: participants]
 36   38   74 
[units: years]
Mean (Standard Deviation)
 26.5  (8.1)   26.5  (7.4)   26.5  (7.7) 
[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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