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Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958828
First Posted: August 13, 2009
Last Update Posted: July 10, 2012
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.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
August 11, 2009
August 13, 2009
September 23, 2010
October 19, 2010
July 10, 2012
July 2009
September 2009   (Final data collection date for primary outcome measure)
Overall Lens Satisfaction [ Time Frame: After 1 week of wear ]
Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.
subjective ratings of two daily disposable contact lenses [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00958828 on ClinicalTrials.gov Archive Site
Not Provided
  • lens fit [ Time Frame: 2 weeks ]
  • lens surface variables [ Time Frame: 2 weeks ]
Not Provided
Not Provided
 
Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Myopia
  • Device: Nelfilcon A contact lens
    Spherical, soft contact lens for daily disposable wear
  • Device: Narafilcon A contact lens
    Spherical, soft contact lens for daily disposable wear
  • Nelfilcon A / Narafilcon A
    Nelfilcon A contact lenses, then Narafilcon A contact lenses
    Interventions:
    • Device: Nelfilcon A contact lens
    • Device: Narafilcon A contact lens
  • Narafilcon A / Nelfilcon A
    Narafilcon A contact lenses, then Nelfilcon A contact lenses
    Interventions:
    • Device: Nelfilcon A contact lens
    • Device: Narafilcon A contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment.
  • Currently wearing contact lenses at least 8 hours/day and 5 days/week.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in any clinical trial.
  • Prior history of corneal or refractive surgery.
  • Monovision correction.
  • Other protocol inclusion/exclusion criteria may apply.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00958828
P-337-C-028
No
Not Provided
Not Provided
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP