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Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT01233076
Recruitment Status : Completed
First Posted : November 3, 2010
Results First Posted : September 8, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Condition or disease Intervention/treatment Phase
Myopia Device: Nelfilcon A contact lens Device: Narafilcon B contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Nelfilcon A / Narafilcon B
Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE TruEye
Narafilcon B / Nelfilcon A
Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE TruEye



Primary Outcome Measures :
  1. Overall Vision Quality [ Time Frame: 1 week of wear ]
    Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
  • Able to wear study lenses in the available powers from -1.00D to -6.00D.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury within twelve weeks of enrollment.
  • History of corneal or refractive surgery.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
  • Monovision correction during the study.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01233076     History of Changes
Other Study ID Numbers: P-337-C-034
First Posted: November 3, 2010    Key Record Dates
Results First Posted: September 8, 2011
Last Update Posted: July 10, 2012
Last Verified: January 2012