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Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon A contact lens
Comfilcon 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:

  • Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
  • Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
  • Replace lenses on a weekly or longer schedule
  • Other protocol 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
  • Current soft toric lens wearers
  • Those who dispose of their soft lenses on a daily basis
  • Current NIGHT & DAY® or Biofinity® 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

    Lotrafilcon A

    Comfilcon A

    Arm Description

    Investigational, spherical, silicone hydrogel contact lenses

    Commercially marketed, spherical, silicone hydrogel contact lenses

    Outcomes

    Primary Outcome Measures

    Comfort at End of Day
    Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 17, 2008
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00810511
    Brief Title
    Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
    Official Title
    Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (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 trial is to compare two different contact lenses during 4 weeks of wear.

    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
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    213 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lotrafilcon A
    Arm Type
    Experimental
    Arm Description
    Investigational, spherical, silicone hydrogel contact lenses
    Arm Title
    Comfilcon A
    Arm Type
    Active Comparator
    Arm Description
    Commercially marketed, spherical, silicone hydrogel contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon A contact lens
    Intervention Description
    Silicone hydrogel contact lens
    Intervention Type
    Device
    Intervention Name(s)
    Comfilcon A contact lens
    Intervention Description
    Silicone hydrogel contact lens
    Primary Outcome Measure Information:
    Title
    Comfort at End of Day
    Description
    Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    After 4 weeks of wear

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses Replace lenses on a weekly or longer schedule Other protocol 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 Current soft toric lens wearers Those who dispose of their soft lenses on a daily basis Current NIGHT & DAY® or Biofinity® lens wearers Other protocol-defined inclusion/exclusion criteria may apply

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

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