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Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03888469
Collaborator
(none)
92
Enrollment
5
Locations
2
Arms
1.7
Actual Duration (Months)
18.4
Patients Per Site
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Verofilcon A contact lenses
  • Device: Etafilcon A contact lenses
 N/A

Detailed Description

Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1
Actual Study Start Date :
May 3, 2019
Actual Primary Completion Date :
Jun 24, 2019
Actual Study Completion Date :
Jun 24, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: DDT2, then 1DAVM

Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

Device: Verofilcon A contact lenses
Investigational daily disposable soft contact lenses
Other Names:
  • DDT2

    • Device: Etafilcon A contact lenses
    Commercially available daily disposable soft contact lenses
    Other Names:
  • 1DAVM
  • 1-DAY ACUVUE® MOIST

    		•
    Other: 1DAVM, then DDT2

    Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.

    Device: Verofilcon A contact lenses
    Investigational daily disposable soft contact lenses
    Other Names:
  • DDT2

    • Device: Etafilcon A contact lenses
    Commercially available daily disposable soft contact lenses
    Other Names:
  • 1DAVM
  • 1-DAY ACUVUE® MOIST

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Least Squares Mean Distance Visual Acuity With Study Lenses [Day 8, each product]

      Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

    Eligibility Criteria

    Criteria

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

    • Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.

    • Willing and able to attend all scheduled study visits as required per protocol.

    • Current wearer of spherical soft contact lenses.

    Key Exclusion Criteria:

    • Any ocular condition that contraindicates contact lens wear.

    • Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigative Site Jacksonville Florida United States 32256
    2 Alcon Investigative Site Maitland Florida United States 32751
    3 Alcon Investigative Site Orlando Florida United States 32803
    4 Alcon Investigative Site Powell Ohio United States 43065
    5 Alcon Investigative Site Memphis Tennessee United States 38111

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: CDMA Project Lead, Vision Care, Alcon Research

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03888469
    Other Study ID Numbers:
    • CLE383-C007
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Jun 25, 2020
    Last Verified:
    Jun 1, 2020
    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.:
    No
    Keywords provided by Alcon Research
    Visual acuity
    VA
    Daily disposable contact lenses
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    Participant Flow

    Recruitment Details This study was performed at 5 study centers in the United States (US).
    Pre-assignment Detail This reporting group includes all randomized subjects (92).
    Arm/Group Title DDT2, Then 1DAVM 1DAVM, Then DDT2
    Arm/Group Description Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
    Period Title: First Wear Period (8 -1/+2 Days)
    STARTED 46 46
    COMPLETED 46 46
    NOT COMPLETED 0 0
    Period Title: First Wear Period (8 -1/+2 Days)
    STARTED 46 46
    COMPLETED 46 46
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title DDT2, Then 1DAVM 1DAVM, Then DDT2 Total
    Arm/Group Description Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. Total of all reporting groups
    Overall Participants 46 46 92
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.6
    (8.5)
    31.5
    (7.8)
    32.6
    (8.2)
    Sex: Female, Male (Count of Participants)
    Female
    31
    67.4%
    28
    60.9%
    59
    64.1%
    Male
    15
    32.6%
    18
    39.1%
    33
    35.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    4.3%
    8
    17.4%
    10
    10.9%
    Not Hispanic or Latino
    44
    95.7%
    38
    82.6%
    82
    89.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    43
    93.5%
    40
    87%
    83
    90.2%
    Black or African American
    2
    4.3%
    4
    8.7%
    6
    6.5%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    2.2%
    1
    1.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Other
    1
    2.2%
    1
    2.2%
    2
    2.2%
    Region of Enrollment (participants) [Number]
    United States
    46
    100%
    46
    100%
    92
    100%

    Outcome Measures

    1. Primary Outcome
    Title Least Squares Mean Distance Visual Acuity With Study Lenses
    Description Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
    Time Frame Day 8, each product

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS): All randomized subjects who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting.
    Arm/Group Title DDT2 1DAVM
    Arm/Group Description Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
    Measure Participants 92 92
    Measure eyes 184 184
    Least Squares Mean (Standard Error) [logMar]
    -0.13
    (0.008)
    -0.12
    (0.008)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DDT2, 1DAVM
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin = 0.05
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.00
    Confidence Interval (1-Sided) 95%
    to 0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = DDT2 - Moist

    Adverse Events

    Time Frame Adverse events were collected from time of consent to study exit (approximately 14-20 days). The safety analysis set included all subjects/eyes exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for the purpose of parameter optimization and fitting, as they were not intended for the assessment of safety.
    Adverse Event Reporting Description Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population of ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
    Arm/Group Title DDT2 - Ocular DDT2 - Systemic / Nonocular 1DAVM - Ocular 1DAVM - Systemic / Nonocular
    Arm/Group Description Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
    All Cause Mortality
    DDT2 - Ocular DDT2 - Systemic / Nonocular 1DAVM - Ocular 1DAVM - Systemic / Nonocular
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/184 (0%) 0/92 (0%) 0/184 (0%) 0/92 (0%)
    Serious Adverse Events
    DDT2 - Ocular DDT2 - Systemic / Nonocular 1DAVM - Ocular 1DAVM - Systemic / Nonocular
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/184 (0%) 0/92 (0%) 0/184 (0%) 0/92 (0%)
    Other (Not Including Serious) Adverse Events
    DDT2 - Ocular DDT2 - Systemic / Nonocular 1DAVM - Ocular 1DAVM - Systemic / Nonocular
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/184 (0%) 0/92 (0%) 0/184 (0%) 0/92 (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 CDMA Project Lead, Vision Care
    Organization Alcon Research, LLC
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03888469
    Other Study ID Numbers:
    • CLE383-C007
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Jun 25, 2020
    Last Verified:
    Jun 1, 2020