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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00708032
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : December 8, 2011
Last Update Posted : May 21, 2015
University of Manchester
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Refractive Error
Interventions: Device: spectacles
Device: narafilcon A soft contact lenses

  Participant Flow

  Baseline Characteristics

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 Analyzed 
[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

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

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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