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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Nelfilcon A / Narafilcon A

    Narafilcon A / Nelfilcon A

    Arm Description

    Nelfilcon A contact lenses, then Narafilcon A contact lenses

    Narafilcon A contact lenses, then Nelfilcon A contact lenses

    Outcomes

    Primary Outcome Measures

    Overall Lens Satisfaction
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2009
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00958828
    Brief Title
    Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
    Official Title
    Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 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 performance of two 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
    Participant
    Allocation
    Randomized
    Enrollment
    178 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nelfilcon A / Narafilcon A
    Arm Type
    Other
    Arm Description
    Nelfilcon A contact lenses, then Narafilcon A contact lenses
    Arm Title
    Narafilcon A / Nelfilcon A
    Arm Type
    Other
    Arm Description
    Narafilcon A contact lenses, then Nelfilcon A contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A contact lens
    Intervention Description
    Spherical, soft contact lens for daily disposable wear
    Intervention Type
    Device
    Intervention Name(s)
    Narafilcon A contact lens
    Intervention Description
    Spherical, soft contact lens for daily disposable wear
    Primary Outcome Measure Information:
    Title
    Overall Lens Satisfaction
    Description
    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.
    Time Frame
    After 1 week of wear

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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