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Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

Sponsor
CIBA VISION (Industry)
Overall Status
Completed
CT.gov ID
NCT01233076
Collaborator
(none)
60
Enrollment
2
Arms
1
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Condition or Disease Intervention/Treatment Phase
  • Device: Nelfilcon A contact lens
  • Device: Narafilcon B contact lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: Nelfilcon A / Narafilcon B

Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Names:
  • DAILIES AquaComfort Plus

    • Device: Narafilcon B contact lens
    Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
    Other Names:
  • 1-DAY ACUVUE TruEye

    		•
    Other: Narafilcon B / Nelfilcon A

    Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

    Device: Nelfilcon A contact lens
    Commercially marketed, spherical contact lens for daily wear, daily disposable use
    Other Names:
  • DAILIES AquaComfort Plus

    • Device: Narafilcon B contact lens
    Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
    Other Names:
  • 1-DAY ACUVUE TruEye

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Vision Quality [1 week of wear]

      Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.

    • Able to wear study lenses in the available powers from -1.00D to -6.00D.

    • Other protocol-defined inclusion/exclusion criteria may apply.

    Exclusion Criteria:

    • Eye injury within twelve weeks of enrollment.

    • History of corneal or refractive surgery.

    • Pre-existing ocular irritation that would preclude contact lens fitting.

    • Currently enrolled in any clinical trial.

    • Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.

    • Monovision correction during the study.

    • Other protocol-defined inclusion/exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CIBA VISION

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01233076
    Other Study ID Numbers:
    • P-337-C-034
    First Posted:
    Nov 3, 2010
    Last Update Posted:
    Jul 10, 2012
    Last Verified:
    Jan 1, 2012
    Additional relevant MeSH terms:
    Myopia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail This reporting group includes all enrolled and dispensed participants.
    Arm/Group Title Nelfilcon A / Narafilcon B Narafilcon B / Nelfilcon A
    Arm/Group Description Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
    Period Title: Period 1, One Week
    STARTED 30 30
    COMPLETED 30 30
    NOT COMPLETED 0 0
    Period Title: Period 1, One Week
    STARTED 30 30
    COMPLETED 29 30
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description This reporting group includes all enrolled and dispensed participants.
    Overall Participants 60
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    30.6
    (12.4)
    Sex: Female, Male (Count of Participants)
    Female
    40
    66.7%
    Male
    20
    33.3%

    Outcome Measures

    1. Primary Outcome
    Title Overall Vision Quality
    Description Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame 1 week of wear

    Outcome Measure Data

    Analysis Population Description
    Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
    Arm/Group Title Nelfilcon A Narafilcon B
    Arm/Group Description Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week. Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
    Measure Participants 59 59
    Mean (Standard Deviation) [units on a scale]
    8.2
    (1.7)
    8.7
    (1.5)

    Adverse Events

    Time Frame Adverse event data were collected for the duration of the trial: 41 days.
    Adverse Event Reporting Description This reporting group includes all enrolled and exposed subjects.
    Arm/Group Title Nelfilcon A Narafilcon B
    Arm/Group Description Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week. Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
    All Cause Mortality
    Nelfilcon A Narafilcon B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Nelfilcon A Narafilcon B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/60 (0%)
    Other (Not Including Serious) Adverse Events
    Nelfilcon A Narafilcon B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/60 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.

    Results Point of Contact

    Name/Title Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management
    Organization CIBA VISION
    Phone 1-678-415-3343
    Email Joseph.Rappon@cibavision.com
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01233076
    Other Study ID Numbers:
    • P-337-C-034
    First Posted:
    Nov 3, 2010
    Last Update Posted:
    Jul 10, 2012
    Last Verified:
    Jan 1, 2012