Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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):
Vistakon Identifier:
First received: June 27, 2008
Last updated: July 17, 2014
Last verified: July 2014
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
  Hide 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  
Number of 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
  Show All 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
  Hide 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.

  More Information