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Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon A Experimental Contact Lens
Lotrafilcon A Commercial 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

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

Inclusion Criteria:

  • Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
  • On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Requires concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrollment
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
  • Any active corneal infection
  • Any use of medications for which contact lens wear would be contraindicated
  • History of corneal refractive surgery
  • Wears toric contact lenses
  • 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

    Experimental Lotrafilcon A Contact Lens

    Commercial Lotrafilcon A Contact Lens

    Arm Description

    Lotrafilcon A experimental contact lens randomly assigned to one eye

    Lotrafilcon A commercial contact lens randomly assigned to one eye

    Outcomes

    Primary Outcome Measures

    Overall Vision
    Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2008
    Last Updated
    May 1, 2023
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00813982
    Brief Title
    Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
    Official Title
    Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (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 compare an experimental contact lens with a currently marketed contact lens.

    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
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Lotrafilcon A Contact Lens
    Arm Type
    Experimental
    Arm Description
    Lotrafilcon A experimental contact lens randomly assigned to one eye
    Arm Title
    Commercial Lotrafilcon A Contact Lens
    Arm Type
    Active Comparator
    Arm Description
    Lotrafilcon A commercial contact lens randomly assigned to one eye
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon A Experimental Contact Lens
    Intervention Description
    Experimental spherical, silicone hydrogel soft contact lens
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon A Commercial Contact Lens
    Intervention Description
    Commercially marketed spherical, silicone hydrogel soft contact lens
    Primary Outcome Measure Information:
    Title
    Overall Vision
    Description
    Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses Other protocol-defined inclusion/exclusion criteria may apply Exclusion Criteria: Requires concurrent ocular medication Eye injury or surgery within twelve weeks immediately prior to enrollment Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions Any active corneal infection Any use of medications for which contact lens wear would be contraindicated History of corneal refractive surgery Wears toric contact lenses Other protocol-defined inclusion/exclusion criteria may apply

    12. IPD Sharing Statement

    Learn more about this trial

    Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

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