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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00958828
First received: August 11, 2009
Last updated: June 26, 2012
Last verified: January 2012

August 11, 2009
June 26, 2012
July 2009
September 2009   (final data collection date for primary outcome measure)
Overall Lens Satisfaction [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958828 on ClinicalTrials.gov Archive Site
Not Provided
  • lens fit [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • lens surface variables [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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 Blind (Subject)
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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00958828
P-337-C-028
No
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