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Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon 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:

  • On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
  • Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
  • Be able to wear the study lenses in the available powers.
  • Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • History of corneal refractive surgery.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lotrafilcon A

    Arm Description

    Investigational contact lens worn in both eyes for three months

    Outcomes

    Primary Outcome Measures

    Comfort After Insertion
    Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 2, 2009
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00933166
    Brief Title
    Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
    Official Title
    Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 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 trial is to assess the performance of an investigational contact lens over a three month period.

    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
    None (Open Label)
    Allocation
    N/A
    Enrollment
    169 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lotrafilcon A
    Arm Type
    Experimental
    Arm Description
    Investigational contact lens worn in both eyes for three months
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon A contact lens
    Intervention Description
    Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months
    Primary Outcome Measure Information:
    Title
    Comfort After Insertion
    Description
    Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses. Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent. Be able to wear the study lenses in the available powers. Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. History of corneal refractive surgery. Other protocol-defined inclusion/exclusion criteria may apply.

    12. IPD Sharing Statement

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    Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

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