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Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A 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 DAILIES TOTAL1, Alcon, contact lens

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sign Informed Consent.
  • No previous contact lens experience or attempt to try contact lenses (neophyte).
  • Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
  • Use spectacle lenses for vision correction.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • 45 years or older.
  • Prior wear experience with rigid or soft contact lenses.
  • Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
  • History of ocular surgery/trauma within the last six months.
  • Pregnant or nursing women.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Delefilcon A

    Arm Description

    Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.

    Outcomes

    Primary Outcome Measures

    Initial Comfort
    Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Comfort at Insertion by Visit
    Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Comfort During the Day by Visit
    Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Comfort at End of Day by Visit
    Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Overall Comfort by Visit
    Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Initial Quality of Vision
    Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Quality of Vision at Insertion by Visit
    Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Quality of Vision During the Day by Visit
    Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Quality of Vision at End of Day by Visit
    Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Overall Quality of Vision by Visit
    Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Average Comfortable Daily Wear Time by Visit
    Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.
    Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.
    Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
    The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.
    Likert Statement: I am Interested in Purchasing These Contact Lenses.
    The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.

    Secondary Outcome Measures

    Lens Surface Characteristics: Dry Areas/Non-wetting
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
    Lens Surface Characteristics: Dry Areas/Non-Wetting
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
    Lens Surface Characteristics: Dry Areas/Non-Wetting
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
    Duration of Overall Training Time
    The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.
    Investigator's Satisfaction With Lens Fit by Visit
    The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.
    Investigator's Overall Impression of Surface Wettability by Visit
    The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).
    Investigator's Rating of Ease of Fit
    The investigator indicated agreement/disagreement with the statement, "The study lenses were easy to fit for this subject," by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree.

    Full Information

    First Posted
    December 15, 2011
    Last Updated
    July 12, 2013
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01494545
    Brief Title
    Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
    Official Title
    Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2012 (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 evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    DAILIES TOTAL1, Alcon, contact lens

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Delefilcon A
    Arm Type
    Experimental
    Arm Description
    Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
    Intervention Type
    Device
    Intervention Name(s)
    Delefilcon A contact lens
    Other Intervention Name(s)
    DAILIES® TOTAL1™
    Intervention Description
    Silicone hydrogel contact lens CE-marked for single use, daily disposable wear
    Primary Outcome Measure Information:
    Title
    Initial Comfort
    Description
    Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 1
    Title
    Comfort at Insertion by Visit
    Description
    Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Comfort During the Day by Visit
    Description
    Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Comfort at End of Day by Visit
    Description
    Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Overall Comfort by Visit
    Description
    Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Initial Quality of Vision
    Description
    Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 1
    Title
    Quality of Vision at Insertion by Visit
    Description
    Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Quality of Vision During the Day by Visit
    Description
    Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Quality of Vision at End of Day by Visit
    Description
    Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Overall Quality of Vision by Visit
    Description
    Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
    Time Frame
    Day 7, Day 14
    Title
    Average Comfortable Daily Wear Time by Visit
    Description
    Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.
    Time Frame
    Day 7, Day 14
    Title
    Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
    Description
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
    Description
    The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Title
    Likert Statement: I am Interested in Purchasing These Contact Lenses.
    Description
    The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.
    Time Frame
    Day 14
    Secondary Outcome Measure Information:
    Title
    Lens Surface Characteristics: Dry Areas/Non-wetting
    Description
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
    Time Frame
    Day 1
    Title
    Lens Surface Characteristics: Dry Areas/Non-Wetting
    Description
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
    Time Frame
    Day 7
    Title
    Lens Surface Characteristics: Dry Areas/Non-Wetting
    Description
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
    Time Frame
    Day 14
    Title
    Duration of Overall Training Time
    Description
    The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.
    Time Frame
    Day 1
    Title
    Investigator's Satisfaction With Lens Fit by Visit
    Description
    The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.
    Time Frame
    Day 1, Day 7, Day 14
    Title
    Investigator's Overall Impression of Surface Wettability by Visit
    Description
    The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).
    Time Frame
    Day 1, Day 7, Day 14
    Title
    Investigator's Rating of Ease of Fit
    Description
    The investigator indicated agreement/disagreement with the statement, "The study lenses were easy to fit for this subject," by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree.
    Time Frame
    Day 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign Informed Consent. No previous contact lens experience or attempt to try contact lenses (neophyte). Willing to wear study lenses for at least 8 hours a day for at least 5 days a week. Use spectacle lenses for vision correction. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 45 years or older. Prior wear experience with rigid or soft contact lenses. Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study. History of ocular surgery/trauma within the last six months. Pregnant or nursing women. Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jami Kern, PhD
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

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