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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A contact lens
Narafilcon B contact lens
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Nelfilcon A / Narafilcon B

    Narafilcon B / Nelfilcon A

    Arm Description

    Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

    Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

    Outcomes

    Primary Outcome Measures

    Overall Vision Quality
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2010
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01233076
    Brief Title
    Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CIBA VISION

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nelfilcon A / Narafilcon B
    Arm Type
    Other
    Arm Description
    Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
    Arm Title
    Narafilcon B / Nelfilcon A
    Arm Type
    Other
    Arm Description
    Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A contact lens
    Other Intervention Name(s)
    DAILIES AquaComfort Plus
    Intervention Description
    Commercially marketed, spherical contact lens for daily wear, daily disposable use
    Intervention Type
    Device
    Intervention Name(s)
    Narafilcon B contact lens
    Other Intervention Name(s)
    1-DAY ACUVUE TruEye
    Intervention Description
    Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
    Primary Outcome Measure Information:
    Title
    Overall Vision Quality
    Description
    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.
    Time Frame
    1 week of wear

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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