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Comparison of Two Multifocal Contact Lenses

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B 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 Presbyopia

Eligibility Criteria

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

Inclusion Criteria:

  • At least 35 years of age.
  • Sign written Informed Consent
  • Spectacle add of +0.50 to +2.50D.
  • Best corrected visual acuity of at least 20.30 in both eyes.
  • Currently wearing soft contact lenses at least 5 days per week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Currently enrolled in any clinical trial.
  • Astigmatism > 1.00D.
  • Strabismus/amblyopia.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Lotrafilcon B / Comfilcon A

    Comfilcon A /Lotrafilcon B

    Arm Description

    Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.

    Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.

    Outcomes

    Primary Outcome Measures

    Overall Vision
    Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2010
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01250054
    Brief Title
    Comparison of Two Multifocal Contact Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (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 compare two multifocal contact lenses in presbyopic wearers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lotrafilcon B / Comfilcon A
    Arm Type
    Other
    Arm Description
    Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
    Arm Title
    Comfilcon A /Lotrafilcon B
    Arm Type
    Other
    Arm Description
    Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B contact lens
    Other Intervention Name(s)
    AIR OPTIX AQUA MULTIFOCAL
    Intervention Description
    Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
    Intervention Type
    Device
    Intervention Name(s)
    Comfilcon A contact lens
    Other Intervention Name(s)
    BIOFINITY MULTIFOCAL
    Intervention Description
    Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
    Primary Outcome Measure Information:
    Title
    Overall Vision
    Description
    Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.
    Time Frame
    One week of wear

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 35 years of age. Sign written Informed Consent Spectacle add of +0.50 to +2.50D. Best corrected visual acuity of at least 20.30 in both eyes. Currently wearing soft contact lenses at least 5 days per week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Currently enrolled in any clinical trial. Astigmatism > 1.00D. Strabismus/amblyopia. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Two Multifocal Contact Lenses

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