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Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Primary Purpose

Presbyopia, Hyperopia, Refractive Error

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A multifocal contact lenses
Lotrafilcon B multifocal contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring contact lenses, multifocal, daily disposable, silicone hydrogel, presbyopia

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with normal eyes who are not using any ocular medication.
  • Must sign the Informed Consent document.
  • Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
  • Manifest cylinder less than or equal to 0.75D.
  • Best corrected distance VA greater than or equal to 20/25 in each eye.
  • Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
  • Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
  • Any use of systemic or ocular medications for which CL wear could be contraindicated.
  • History of herpetic keratitis.
  • History of refractive surgery or irregular cornea.
  • A clinically significant dry eye that precludes CL wear.
  • Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
  • Monocular (only 1 eye with functional vision).
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Delefilcon A MF, then AOAMF

    AOAMF, then Delefilcon A MF

    Arm Description

    Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

    Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

    Outcomes

    Primary Outcome Measures

    High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
    Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

    Secondary Outcome Measures

    HC/HI Binocular VA at Distance
    Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
    Over-refraction (OR) Monocular at Distance
    OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.

    Full Information

    First Posted
    September 24, 2013
    Last Updated
    November 24, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01951573
    Brief Title
    Evaluation of a New Daily Disposable Multifocal Contact Lens Design
    Official Title
    Delefilcon A Multifocal Plus Power Lens Design Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia, Hyperopia, Refractive Error
    Keywords
    contact lenses, multifocal, daily disposable, silicone hydrogel, presbyopia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Delefilcon A MF, then AOAMF
    Arm Type
    Other
    Arm Description
    Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
    Arm Title
    AOAMF, then Delefilcon A MF
    Arm Type
    Other
    Arm Description
    Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
    Intervention Type
    Device
    Intervention Name(s)
    Delefilcon A multifocal contact lenses
    Intervention Description
    Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B multifocal contact lenses
    Other Intervention Name(s)
    AIR OPTIX® AQUA MULTIFOCAL
    Intervention Description
    Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement
    Primary Outcome Measure Information:
    Title
    High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
    Description
    Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
    Time Frame
    Dispense (Day 1), Hour 9
    Secondary Outcome Measure Information:
    Title
    HC/HI Binocular VA at Distance
    Description
    Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
    Time Frame
    Dispense (Day 1), Hour 9
    Title
    Over-refraction (OR) Monocular at Distance
    Description
    OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.
    Time Frame
    Dispense (Day 1), Hour 9

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with normal eyes who are not using any ocular medication. Must sign the Informed Consent document. Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)). Manifest cylinder less than or equal to 0.75D. Best corrected distance VA greater than or equal to 20/25 in each eye. Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week. Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular disease, inflammation, or abnormality that contraindicates CL wear. Any use of systemic or ocular medications for which CL wear could be contraindicated. History of herpetic keratitis. History of refractive surgery or irregular cornea. A clinically significant dry eye that precludes CL wear. Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days. Monocular (only 1 eye with functional vision). History of intolerance or hypersensitivity to any component of the test articles. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joachim Nick, Dipl. Ing.
    Organizational Affiliation
    CIBA VISION GmbH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of a New Daily Disposable Multifocal Contact Lens Design

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