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Lubricity Post-Wear - Competitive Lenses Pilot

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02402127
Collaborator
(none)
24
Enrollment
6
Arms
2
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

Condition or Disease Intervention/Treatment Phase
  • Device: Narafilcon A contact lenses
  • Device: Stenfilcon A contact lenses
  • Device: Somofilcon A contact lenses
 N/A

Detailed Description

In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: TruEye, MyDay, clariti 1day

Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 1 day (16 hours).

Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)

    • Device: Stenfilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay™

    • Device: Somofilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • clariti® 1day

    		•
    Other: TruEye, clariti 1day, MyDay

    Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

    Device: Narafilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)

    • Device: Stenfilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay™

    • Device: Somofilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • clariti® 1day

    		•
    Other: MyDay, TruEye, clariti 1day

    Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

    Device: Narafilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)

    • Device: Stenfilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay™

    • Device: Somofilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • clariti® 1day

    		•
    Other: MyDay, clariti 1day, TruEye

    Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

    Device: Narafilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)

    • Device: Stenfilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay™

    • Device: Somofilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • clariti® 1day

    		•
    Other: Clariti 1day, TruEye, MyDay

    Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

    Device: Narafilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)

    • Device: Stenfilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay™

    • Device: Somofilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • clariti® 1day

    		•
    Other: Clariti 1day, MyDay, TruEye

    Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

    Device: Narafilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)

    • Device: Stenfilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay™

    • Device: Somofilcon A contact lenses
    Silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • clariti® 1day

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Average Coefficient of Friction of Worn Lenses at 16 Hours [Day 1, Hour 16, each product]

      Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

    Secondary Outcome Measures

    1. Average Coefficient of Friction of Unworn Lenses [Day 1 (each product)]

      Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must sign an informed consent form.

    • Soft contact lens wearer (both eyes).

    • Willing to wear study lenses at least 16 waking hours and attend all study visits.

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:

    • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.

    • Use of systemic or ocular medications for which contact lens wear could be contraindicated.

    • Use of artificial tears and rewetting drops during the study.

    • Monocular (only 1 eye with functional vision) or fit with only 1 lens.

    • History of herpetic keratitis, ocular surgery, or irregular cornea.

    • Pregnant.

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Manager, Vision Care, Global Medical Affairs, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02402127
    Other Study ID Numbers:
    • CLT567-P001
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Sep 2, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Alcon Research
    Contact lenses
    Lubricity
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from three investigational centers located in the United States.
    Pre-assignment Detail All enrolled participants (24)
    Arm/Group Title TruEye, MyDay, Clariti 1day TruEye, Clariti 1day, MyDay MyDay, TruEye, Clariti 1day MyDay, Clariti 1day, TruEye Clariti 1day, TruEye, MyDay Clariti 1day, MyDay, TruEye
    Arm/Group Description Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
    Period Title: First Wear Period (1 Day)
    STARTED 4 4 4 4 4 4
    Randomized and Treated 4 4 4 4 4 4
    COMPLETED 4 4 4 4 4 4
    NOT COMPLETED 0 0 0 0 0 0
    Period Title: First Wear Period (1 Day)
    STARTED 4 4 4 4 4 4
    COMPLETED 4 4 4 4 4 4
    NOT COMPLETED 0 0 0 0 0 0
    Period Title: First Wear Period (1 Day)
    STARTED 4 4 4 4 4 4
    COMPLETED 4 4 4 4 4 4
    NOT COMPLETED 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title TruEye, MyDay, Clariti 1day TruEye, Clariti 1day, MyDay MyDay, TruEye, Clariti 1day MyDay, Clariti 1day, TruEye Clariti 1day, TruEye, MyDay Clariti 1day, MyDay, TruEye Total
    Arm/Group Description Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 Total of all reporting groups
    Overall Participants 4 4 4 4 4 4 24
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    34.0
    (9.6)
    27.5
    (4.0)
    33.0
    (7.3)
    35.3
    (4.6)
    26.3
    (6.2)
    24.3
    (2.4)
    30.0
    (6.9)
    Age, Customized (participants) [Number]
    18-64 years
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    24
    100%
    ≥65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    2
    50%
    2
    50%
    3
    75%
    2
    50%
    4
    100%
    2
    50%
    15
    62.5%
    Male
    2
    50%
    2
    50%
    1
    25%
    2
    50%
    0
    0%
    2
    50%
    9
    37.5%

    Outcome Measures

    1. Primary Outcome
    Title Average Coefficient of Friction of Worn Lenses at 16 Hours
    Description Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
    Time Frame Day 1, Hour 16, each product

    Outcome Measure Data

    Analysis Population Description
    Intention to treat participants with non-missing observations
    Arm/Group Title TruEye MyDay Clariti 1day
    Arm/Group Description Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3 Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3 Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
    Measure Participants 18 18 18
    Mean (Standard Deviation) [unitless]
    0.0602
    (0.00474)
    0.0576
    (0.00338)
    0.0578
    (0.00439)
    2. Secondary Outcome
    Title Average Coefficient of Friction of Unworn Lenses
    Description Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.
    Time Frame Day 1 (each product)

    Outcome Measure Data

    Analysis Population Description
    Intention to treat participants with non-missing observations
    Arm/Group Title TruEye MyDay Clariti 1day
    Arm/Group Description Narafilcon A contact lenses Stenfilcon A contact lenses Somofilcon A contact lenses
    Measure Participants 18 18 18
    Measure contact lenses 18 18 18
    Mean (Standard Deviation) [unitless]
    0.0571
    (0.00324)
    0.0571
    (0.00260)
    0.0552
    (0.00305)

    Adverse Events

    Time Frame Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 17 days). This analysis population includes all participants exposed to investigational product.
    Adverse Event Reporting Description AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, whether or not related to the medical device, obtained through solicited and spontaneous comments from all exposed participants and reported based on the treatment received. Ocular AEs are presented for both eyes combined.
    Arm/Group Title TruEye MyDay Clariti 1day
    Arm/Group Description Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3 Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3 Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
    All Cause Mortality
    TruEye MyDay Clariti 1day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    TruEye MyDay Clariti 1day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/24 (0%) 0/24 (0%)
    Other (Not Including Serious) Adverse Events
    TruEye MyDay Clariti 1day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/24 (0%) 0/24 (0%) 0/24 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

    Results Point of Contact

    Name/Title Global Medical Affairs Franchise Head, Vision Care
    Organization Alcon Research, Ltd.
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02402127
    Other Study ID Numbers:
    • CLT567-P001
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Sep 2, 2016
    Last Verified:
    Jul 1, 2016