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Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A contact lens
Narafilcon A 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 wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
  • Habitually wear lenses for at least 8 hours per day and 4 days per week.
  • Report 2 or more qualifying symptoms with current contact lenses.
  • Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
  • Other protocol-defined 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 ocular medications, exclusive of contact lens rewetting drops.
  • History of corneal or refractive surgery.
  • Cylinder correction greater than 1.00 D
  • Current monovision contact lens wearers.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Nelfilcon A

    Narafilcon A

    Arm Description

    Nelfilcon A contact lens

    Narafilcon A contact lens

    Outcomes

    Primary Outcome Measures

    Lens Awareness
    Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire 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 always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2009
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01035905
    Brief Title
    Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
    Official Title
    Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

    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
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nelfilcon A
    Arm Type
    Experimental
    Arm Description
    Nelfilcon A contact lens
    Arm Title
    Narafilcon A
    Arm Type
    Active Comparator
    Arm Description
    Narafilcon A contact lens
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A contact lens
    Intervention Description
    Daily disposable contact lens worn in a daily wear, daily disposable mode
    Intervention Type
    Device
    Intervention Name(s)
    Narafilcon A contact lens
    Intervention Description
    Daily disposable contact lens worn in a daily wear, daily disposable mode
    Primary Outcome Measure Information:
    Title
    Lens Awareness
    Description
    Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire 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 always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.
    Time Frame
    4 weeks of wear

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months. Habitually wear lenses for at least 8 hours per day and 4 days per week. Report 2 or more qualifying symptoms with current contact lenses. Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense. Other protocol-defined 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 ocular medications, exclusive of contact lens rewetting drops. History of corneal or refractive surgery. Cylinder correction greater than 1.00 D Current monovision contact lens wearers. Other protocol-defined inclusion/exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

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