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Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

Primary Purpose

Refractive Error, Myopia, Myopic Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A contact lenses
Etafilcon A contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring Soft contact lenses, DACP

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
  • Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
  • Those who play ball sports at least 1 day per week
  • Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Those who regularly wear the study device
  • Those who require ocular treatment with eye drops
  • Those who have a condition contraindicating soft contact lens wear, such as eye irritation
  • Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
  • Those who are participating in another clinical study or research or have a plan of such participation during the present study
  • Women who are pregnant or intend to become pregnant during the study
  • Other protocol-defined exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    DACP, then 1DAM

    1DAM, then DACP

    Arm Description

    Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.

    Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.

    Outcomes

    Primary Outcome Measures

    Mean Investigator-Rated Lens Centration
    Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.

    Secondary Outcome Measures

    Mean Investigator-Rated Lens Fit
    Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.
    Average Subjective Ratings Score (Lens Handling and Overall Vision)
    The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.
    Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
    The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.

    Full Information

    First Posted
    April 1, 2014
    Last Updated
    October 24, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02103309
    Brief Title
    Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan
    Official Title
    Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 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 evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Error, Myopia, Myopic Astigmatism
    Keywords
    Soft contact lenses, DACP

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DACP, then 1DAM
    Arm Type
    Other
    Arm Description
    Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
    Arm Title
    1DAM, then DACP
    Arm Type
    Other
    Arm Description
    Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A contact lenses
    Other Intervention Name(s)
    DAILIES® AquaComfort® Plus, DACP
    Intervention Type
    Device
    Intervention Name(s)
    Etafilcon A contact lenses
    Other Intervention Name(s)
    1-DAY ACUVUE® MOIST®
    Primary Outcome Measure Information:
    Title
    Mean Investigator-Rated Lens Centration
    Description
    Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.
    Time Frame
    After 1 week of wear
    Secondary Outcome Measure Information:
    Title
    Mean Investigator-Rated Lens Fit
    Description
    Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.
    Time Frame
    After 1 week of wear
    Title
    Average Subjective Ratings Score (Lens Handling and Overall Vision)
    Description
    The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.
    Time Frame
    After 1 week of wear
    Title
    Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
    Description
    The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.
    Time Frame
    After 1 week of wear

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    29 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20 Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week Those who play ball sports at least 1 day per week Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction Other protocol-defined inclusion criteria may apply Exclusion Criteria: Those who regularly wear the study device Those who require ocular treatment with eye drops Those who have a condition contraindicating soft contact lens wear, such as eye irritation Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study Those who are participating in another clinical study or research or have a plan of such participation during the present study Women who are pregnant or intend to become pregnant during the study Other protocol-defined exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa L. Zoota, MPH, CCRA
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

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