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Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

Primary Purpose

Myopia, Ametropia, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A multifocal contact lens with comfort additive
Nelfilcon A multifocal contact lens
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, Presbyopia, Refractive error, Contact lenses, Multifocal

Eligibility Criteria

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

Inclusion Criteria:

  • Sign Informed Consent Document.
  • Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
  • Currently wear soft contact lenses.
  • Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
  • Manifest cylinder less than or equal to 1.00 D.
  • Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
  • Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
  • History of corneal or refractive surgery.
  • Biomicroscopy findings greater than Grade 2 at baseline.
  • A pathologically dry eye that precludes contact lens wear.
  • Monocular (only one eye with functional vision).
  • Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
  • History of intolerance or hypersensitivity to any component of the investigational products.
  • Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
  • Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DAILIES® AquaComfort Plus® Multifocal

    Focus® DAILIES® Progressives

    Arm Description

    Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis

    Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis

    Outcomes

    Primary Outcome Measures

    Subjective Overall Vision
    The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).

    Secondary Outcome Measures

    Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
    Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
    Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
    Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.

    Full Information

    First Posted
    February 21, 2013
    Last Updated
    April 25, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01797783
    Brief Title
    Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
    Official Title
    Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 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 was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Ametropia, Presbyopia, Refractive Error
    Keywords
    Myopia, Presbyopia, Refractive error, Contact lenses, Multifocal

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DAILIES® AquaComfort Plus® Multifocal
    Arm Type
    Experimental
    Arm Description
    Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
    Arm Title
    Focus® DAILIES® Progressives
    Arm Type
    Active Comparator
    Arm Description
    Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A multifocal contact lens with comfort additive
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A multifocal contact lens
    Primary Outcome Measure Information:
    Title
    Subjective Overall Vision
    Description
    The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
    Time Frame
    Up to Day 30
    Secondary Outcome Measure Information:
    Title
    Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
    Description
    Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
    Time Frame
    Up to Day 30
    Title
    Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
    Description
    Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
    Time Frame
    Up to Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign Informed Consent Document. Presbyopic and require a spectacle add of up to and including 3.00 diopters (D). Currently wear soft contact lenses. Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule. Manifest cylinder less than or equal to 1.00 D. Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction). Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment. Any use of systemic or ocular medications for which contact lens wear could be contraindicated. History of corneal or refractive surgery. Biomicroscopy findings greater than Grade 2 at baseline. A pathologically dry eye that precludes contact lens wear. Monocular (only one eye with functional vision). Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis). History of intolerance or hypersensitivity to any component of the investigational products. Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days. Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Justin Webb, O.D.
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

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