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Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03134248
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
5.7
Actual Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses

Condition or Disease Intervention/Treatment Phase
  • Device: Dailies Aquacomfort Plus Toric
  • Device: 1-Day Acuvue Moist for Astigmatism
  • Device: MyDay Toric
 N/A

Detailed Description

Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
Actual Study Start Date :
Oct 19, 2016
Actual Primary Completion Date :
Apr 12, 2017
Actual Study Completion Date :
Apr 12, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: MyDay Toric

Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study

Device: MyDay Toric
daily disposable contact lens
Other Names:
  • MDT

    		•
    Active Comparator: 1-Day Acuvue Moist for Astigmatism

    Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study

    Device: 1-Day Acuvue Moist for Astigmatism
    daily disposable contact lens
    Other Names:
  • 1-Day AM

    		•
    Active Comparator: Dailies Aquacomfort Plus Toric

    Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study

    Device: Dailies Aquacomfort Plus Toric
    daily disposable contact lens
    Other Names:
  • DACP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comfort [1 week]

      Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.

    2. Dryness [1 week]

      Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness

    3. Visual Quality [1 week]

      Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied

    4. Lens Preference With Respect to Overall Comfort [1 week]

      Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference

    5. Lens Preference With Respect to Visual Quality [1 week]

      Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference

    Eligibility Criteria

    Criteria

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

    1. Is at least 17 years of age and has full legal capacity to volunteer;

    2. Has had a self-reported oculo-visual examination in the last two years.

    3. Has read and signed an information consent letter;

    4. Is willing and able to follow instructions and maintain the appointment schedule;

    5. Is an adapted soft contact lens wearer;

    6. Is willing to wear contact lens in both eyes for the duration of the study;

    7. Has a minimum spectacle astigmatism of - 0.75;

    8. Can be fit with the three study contact lens types in the powers available;

    9. Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);

    10. Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.

    11. Has clear corneas and no active* ocular disease;

    • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
    Exclusion Criteria:

    1. Is participating in any concurrent clinical trial;

    2. Has any known active* ocular disease and/or infection;

    3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

    4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

    5. Has known sensitivity to fluorescein dye or products to be used in the study;

    6. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;

    7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

    8. Is aphakic;

    9. Has undergone refractive error surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCLR, University of Waterloo Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT03134248
    Other Study ID Numbers:
    • EX-MKTG-72
    First Posted:
    Apr 28, 2017
    Last Update Posted:
    Sep 12, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Astigmatism

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 60 subjects were enrolled for this study (assigned a subjectID), but 11 of these subjects were screen failures, leaving 49 subjects who were randomized for lens assignments.
    Arm/Group Title 1-Day AM First, Then DACP, Then MDT 1-Day AM First, Then MDT, Then DACP DACP First, Then 1-Day AM, Then MDT DACP First, Then MDT, Then 1-Day AM MDT First, Then 1-Day AM, Then DACP MDT First, Then DACP, Then 1-Day AM
    Arm/Group Description 1-day Acuvue Moist for Astig first, then Dailies Aquacomfort Plus, then MyDay Troic 1-day Acuvue Moist for Astig, then MyDay Toric, then Dailies Aquacomfort Plus Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig, then MyDay Toric Dailies Aquacomfort Plus, then MyDay Toric, then 1-day Acuvue Moist for Astig MyDay Toric, then 1-day Acuvue Moist for Astig, then Dailies Aquacomfort Plus MyDay Toric, then Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig
    Period Title: Week 1
    STARTED 7 8 9 7 9 9
    COMPLETED 7 8 9 7 9 9
    NOT COMPLETED 0 0 0 0 0 0
    Period Title: Week 1
    STARTED 7 8 9 7 9 9
    COMPLETED 7 8 9 7 9 9
    NOT COMPLETED 0 0 0 0 0 0
    Period Title: Week 1
    STARTED 7 8 9 7 9 9
    COMPLETED 7 8 9 7 9 9
    NOT COMPLETED 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title All Study Participants
    Arm/Group Description A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Contact Lenses
    Overall Participants 49
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    49
    100%
    >=65 years
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    37
    75.5%
    Male
    12
    24.5%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (Count of Participants)
    Canada
    49
    100%

    Outcome Measures

    1. Primary Outcome
    Title Comfort
    Description Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MyDay Toric Contact Lens 1-Day Acuvue Moist for Astigmatism Contact Lens Dailies Aquacomfort Plus Toric Contact Lens
    Arm/Group Description Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study. Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study. Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
    Measure Participants 49 49 49
    Median (Standard Deviation) [units on a scale]
    8
    (1.37)
    9
    (1.14)
    8
    (2.05)
    2. Primary Outcome
    Title Dryness
    Description Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MyDay Toric Contact Lens 1-Day Acuvue Moist for Astigmatism Contact Lens Dailies Aquacomfort Plus Toric Contact Lens
    Arm/Group Description Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study. Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study. Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
    Measure Participants 49 49 49
    Median (Standard Deviation) [units on a scale]
    9
    (1.69)
    8
    (1.65)
    7
    (2.18)
    3. Primary Outcome
    Title Visual Quality
    Description Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MyDay Toric Contact Lens 1-Day Acuvue Moist for Astigmatism Contact Lens Dailies Aquacomfort Plus Toric Contact Lens
    Arm/Group Description Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study. Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study. Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
    Measure Participants 49 49 49
    Median (Standard Deviation) [units on a scale]
    9
    (1.41)
    8
    (1.14)
    8
    (1.81)
    4. Primary Outcome
    Title Lens Preference With Respect to Overall Comfort
    Description Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Overall Study
    Arm/Group Description Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses
    Measure Participants 49
    Strongly Prefer MyDay Toric
    15
    30.6%
    Slightly Prefer MyDay Toric
    6
    12.2%
    Strongly Prefer 1Day Acuvue Moist Toric
    14
    28.6%
    Slightly Prefer 1Day Acuvue Moist Toric
    5
    10.2%
    Strongly Prefer Dailies Aquacomfort Plus Toric
    5
    10.2%
    Slighlty Prefer Dailies Aquacomfort Plus Toric
    3
    6.1%
    No Preference
    1
    2%
    5. Primary Outcome
    Title Lens Preference With Respect to Visual Quality
    Description Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
    Time Frame 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Overall Study
    Arm/Group Description A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Lenses
    Measure Participants 49
    Strongly Prefer MyDay Toric
    10
    20.4%
    Slightly Prefer MyDay Toric
    4
    8.2%
    Strongly Prefer 1Day Acuvue Moist Toric
    9
    18.4%
    Slightly Prefer 1Day Acuvue Moist Toric
    8
    16.3%
    Strongly Prefer Dailies Aquacomfort Plus Toric
    6
    12.2%
    Slightly Prefer Dailies Aquacomfort Plus Toric
    2
    4.1%
    No Preference
    10
    20.4%

    Adverse Events

    Time Frame Adverse events were collected during the 3 week study duration.
    Adverse Event Reporting Description Adverse event information was routinely collected during the weekly visits over the study duration or self-reported by the subjects if event was realized outside of visits.
    Arm/Group Title MyDay Toric 1-Day Acuvue Moist for Astigmatism Dailies Aqua Comfort Plus Toric
    Arm/Group Description Participants who wore MyDay Toric contact lenses Participants who wore 1-Day Acuvue Moist for Astigmatism contact lenses Participants who wore Dailies Aqua Comfort Plus Toric contact lenses
    All Cause Mortality
    MyDay Toric 1-Day Acuvue Moist for Astigmatism Dailies Aqua Comfort Plus Toric
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/49 (0%) 0/49 (0%) 0/49 (0%)
    Serious Adverse Events
    MyDay Toric 1-Day Acuvue Moist for Astigmatism Dailies Aqua Comfort Plus Toric
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/49 (0%) 0/49 (0%) 0/49 (0%)
    Other (Not Including Serious) Adverse Events
    MyDay Toric 1-Day Acuvue Moist for Astigmatism Dailies Aqua Comfort Plus Toric
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/49 (0%) 0/49 (0%) 0/49 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.

    Results Point of Contact

    Name/Title Jose A.Vega OD MSc., FAAO
    Organization CooperVision
    Phone 9256213761
    Email javega@coopervision.com
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT03134248
    Other Study ID Numbers:
    • EX-MKTG-72
    First Posted:
    Apr 28, 2017
    Last Update Posted:
    Sep 12, 2019
    Last Verified:
    Aug 1, 2019