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Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953407
First Posted: August 6, 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 )
July 8, 2009
August 6, 2009
September 16, 2010
November 1, 2010
July 10, 2012
July 2009
September 2009   (Final data collection date for primary outcome measure)
Lens Awareness [ Time Frame: 4 weeks of wear ]
Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.
frequency and severity of subjective symptoms [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00953407 on ClinicalTrials.gov Archive Site
Not Provided
  • subjective ratings of comfort [ Time Frame: 4 weeks ]
  • dryness [ Time Frame: 4 weeks ]
  • overall satisfaction versus habitual lenses [ Time Frame: 4 weeks ]
  • overall preference versus habitual lenses [ Time Frame: 4 weeks ]
Not Provided
Not Provided
 
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers
Not Provided
The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myopia
  • Device: Nelfilcon A contact lens
    Daily disposable contact lens worn in a daily wear, daily disposable mode
  • Device: Narafilcon A contact lens
    Daily disposable contact lens worn in a daily wear, daily disposable mode
  • Device: Etafilcon A contact lens
    Daily disposable contact lens worn in a daily wear, daily disposable mode
  • Device: Omafilcon A contact lens
    Daily disposable contact lens worn in a daily wear, daily disposable mode
  • Device: Hilafilcon B contact lens
    Daily disposable contact lens worn in a daily wear, daily disposable mode
  • Experimental: Nelfilcon A
    Nelfilcon A contact lens
    Intervention: Device: Nelfilcon A contact lens
  • Active Comparator: Narafilcon A
    Narafilcon A contact lens
    Intervention: Device: Narafilcon A contact lens
  • Active Comparator: Etafilcon A
    Etafilcon A contact lens
    Intervention: Device: Etafilcon A contact lens
  • Active Comparator: Omafilcon A
    Omafilcon A contact lens
    Intervention: Device: Omafilcon A contact lens
  • Active Comparator: Hilafilcon B
    Hilafilcon B contact lens
    Intervention: Device: Hilafilcon B 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
128
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
  • Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
  • Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
  • Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
  • 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.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of corneal refractive surgery.
  • Cylinder correction greater than 1.00 D.
  • Current monovision contact lens wearers.
  • 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
 
NCT00953407
P-337-C-027
Not Provided
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