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Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02388763
Collaborator
(none)
66
Enrollment
2
Arms
5
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

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

Detailed Description

After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: MyDay, then 1DAVTE

Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.

Device: Stenfilcon A contact lenses
Contact lenses worn during Period 1 or 2, as randomized
Other Names:
  • MyDay™

    • Device: Narafilcon A contact lenses
    Contact lenses worn during Period 1 or 2, as randomized
    Other Names:
  • 1-DAY ACUVUE® TruEye®

    		•
    Other: 1DAVTE, then MyDay

    Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.

    Device: Stenfilcon A contact lenses
    Contact lenses worn during Period 1 or 2, as randomized
    Other Names:
  • MyDay™

    • Device: Narafilcon A contact lenses
    Contact lenses worn during Period 1 or 2, as randomized
    Other Names:
  • 1-DAY ACUVUE® TruEye®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 [Day 10, each product]

      High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

    Secondary Outcome Measures

    1. High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 [Day 10, each product]

      High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.

    Eligibility Criteria

    Criteria

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

    • Must sign informed consent form.

    • Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.

    • Willing to wear lenses every day or at least 5 days per week 6 hours per day.

    • Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:

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

    • Pregnant or lactating.

    • Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.

    • Any abnormal ocular condition as specified in the protocol.

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Trial Manager, EMEA, Alcon, A Novartis Division

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02388763
    Other Study ID Numbers:
    • CLY838-P001
    First Posted:
    Mar 17, 2015
    Last Update Posted:
    Dec 5, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Alcon Research
    Contact lenses
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled from 1 investigative site located in the United Kingdom.
    Pre-assignment Detail Of the 66 enrolled participants, 2 participants were discontinued prior to randomization. This reporting group includes all randomized participants (64).
    Arm/Group Title Habitual, MyDay, 1DAVTE Habitual, 1DAVTE, MyDay
    Arm/Group Description Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
    Period Title: Habitual, 10 Days of Wear
    STARTED 32 32
    COMPLETED 31 31
    NOT COMPLETED 1 1
    Period Title: Habitual, 10 Days of Wear
    STARTED 31 31
    COMPLETED 30 30
    NOT COMPLETED 1 1
    Period Title: Habitual, 10 Days of Wear
    STARTED 30 30
    COMPLETED 30 30
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
    Overall Participants 64
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.8
    (9.71)
    Sex: Female, Male (Count of Participants)
    Female
    45
    70.3%
    Male
    19
    29.7%

    Outcome Measures

    1. Primary Outcome
    Title High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
    Description High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
    Time Frame Day 10, each product

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat
    Arm/Group Title MyDay 1DAVTE
    Arm/Group Description Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
    Measure Participants 60 60
    Mean (Standard Deviation) [VA unit]
    0.453
    (0.673)
    0.341
    (0.781)
    2. Secondary Outcome
    Title High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
    Description High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
    Time Frame Day 10, each product

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat Subjects
    Arm/Group Title MyDay 1DAVTE
    Arm/Group Description Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
    Measure Participants 60 60
    Mean (Standard Deviation) [VA unit]
    0.614
    (0.689)
    0.700
    (0.777)

    Adverse Events

    Time Frame Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1).
    Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.
    Arm/Group Title Pretreatment Dailies Total 1 Clariti 1-Day MyDay 1DAVTE
    Arm/Group Description All subjects who consented to participate in the study prior to the initiation of study treatment Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1 Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1 Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
    All Cause Mortality
    Pretreatment Dailies Total 1 Clariti 1-Day MyDay 1DAVTE
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Pretreatment Dailies Total 1 Clariti 1-Day MyDay 1DAVTE
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/66 (0%) 0/32 (0%) 0/32 (0%) 1/60 (1.7%) 1/61 (1.6%)
    Infections and infestations
    Kidney infection 0/66 (0%) 0/32 (0%) 0/32 (0%) 1/60 (1.7%) 0/61 (0%)
    Renal and urinary disorders
    Renal vein thrombosis 0/66 (0%) 0/32 (0%) 0/32 (0%) 0/60 (0%) 1/61 (1.6%)
    Other (Not Including Serious) Adverse Events
    Pretreatment Dailies Total 1 Clariti 1-Day MyDay 1DAVTE
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/66 (0%) 5/32 (15.6%) 0/32 (0%) 0/60 (0%) 0/61 (0%)
    Infections and infestations
    Nasopharyngitis 0/66 (0%) 2/32 (6.3%) 0/32 (0%) 0/60 (0%) 0/61 (0%)
    Hordeolum 0/66 (0%) 2/32 (6.3%) 0/32 (0%) 0/60 (0%) 0/61 (0%)
    Injury, poisoning and procedural complications
    Foreign body in eye 0/66 (0%) 2/32 (6.3%) 0/32 (0%) 0/60 (0%) 0/61 (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 GMA Franchise Head - Vision Care, GCRA
    Organization Alcon, A Novartis Division
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02388763
    Other Study ID Numbers:
    • CLY838-P001
    First Posted:
    Mar 17, 2015
    Last Update Posted:
    Dec 5, 2016
    Last Verified:
    Oct 1, 2016