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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A contact lenses (DAILIES TOTAL1®)
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
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 contact lenses, myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Sign written Informed Consent Document and HIPAA form.
  • Be current weekly/monthly replacement contact lens wearer.
  • Be willing to not sleep in contact lenses during the study period.
  • Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
  • Have best corrected visual acuity of at least 20/25 in each eye.
  • Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
  • Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Be a neophyte or current wearer of daily disposable lenses.
  • Require monovision correction or use multifocal contact lenses.
  • Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Have a history of ocular surgery/trauma within the last 6 months.
  • Use topical ocular or systemic antibiotics within 7 days of enrollment.
  • Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
  • Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
  • Use re-wetting drops once or more per day.
  • 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, then narafilcon B

    Narafilcon B, then delefilcon A

    Arm Description

    Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

    Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

    Outcomes

    Primary Outcome Measures

    Overall Comfort
    Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

    Secondary Outcome Measures

    Overall Quality of Vision
    Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
    End of Day Comfort
    End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

    Full Information

    First Posted
    July 3, 2012
    Last Updated
    November 27, 2013
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01634659
    Brief Title
    Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
    Official Title
    Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    September 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 compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    contact lenses, myopia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Delefilcon A, then narafilcon B
    Arm Type
    Other
    Arm Description
    Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
    Arm Title
    Narafilcon B, then delefilcon A
    Arm Type
    Other
    Arm Description
    Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
    Intervention Type
    Device
    Intervention Name(s)
    Delefilcon A contact lenses (DAILIES TOTAL1®)
    Intervention Description
    Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
    Intervention Type
    Device
    Intervention Name(s)
    Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
    Intervention Description
    Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use
    Primary Outcome Measure Information:
    Title
    Overall Comfort
    Description
    Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
    Time Frame
    Day 8
    Secondary Outcome Measure Information:
    Title
    Overall Quality of Vision
    Description
    Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
    Time Frame
    Day 8
    Title
    End of Day Comfort
    Description
    End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
    Time Frame
    Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign written Informed Consent Document and HIPAA form. Be current weekly/monthly replacement contact lens wearer. Be willing to not sleep in contact lenses during the study period. Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range. Have best corrected visual acuity of at least 20/25 in each eye. Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week. Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Be a neophyte or current wearer of daily disposable lenses. Require monovision correction or use multifocal contact lenses. Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study. Have a history of ocular surgery/trauma within the last 6 months. Use topical ocular or systemic antibiotics within 7 days of enrollment. Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study. Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment. Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment. Use re-wetting drops once or more per day. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jami Kern, MBA, PhD
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

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