Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03888482
Collaborator
(none)
154
8
2
2.1
19.3
9.3

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 Clariti contact lenses.

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

Detailed Description

Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Study Design

Study Type:
Interventional
Actual Enrollment :
154 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 2
Actual Study Start Date :
Apr 26, 2019
Actual Primary Completion Date :
Jun 28, 2019
Actual Study Completion Date :
Jun 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: DDT2, then Clariti

Verofilcon A contact lenses worn first, with somofilcon 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: Somofilcon A contact lenses
    Commercially available daily disposable soft contact lenses
    Other Names:
  • clariti® 1 day
  • Clariti
  • Other: Clariti, then DDT2

    Somofilcon 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: Somofilcon A contact lenses
    Commercially available daily disposable soft contact lenses
    Other Names:
  • clariti® 1 day
  • Clariti
  • 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 clariti® 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 Bloomington Illinois United States 61701
    5 Alcon Investigative Site Powell Ohio United States 43065
    6 Alcon Investigative Site Warwick Rhode Island United States 02888
    7 Alcon Investigative Site Brentwood Tennessee United States 37027
    8 Alcon Investigative Site Memphis Tennessee United States 38111

    Sponsors and Collaborators

    • Alcon Research

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03888482
    Other Study ID Numbers:
    • CLE383-C010
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Jul 13, 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
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details This study was performed at 8 study centers in the United States (US).
    Pre-assignment Detail Of the 154 enrolled, 2 were exited from the study as screen failures and 1 subject was randomized but not exposed. This reporting group includes all exposed subjects (151).
    Arm/Group Title DDT2, Then Clariti Clariti, Then DDT2
    Arm/Group Description Verofilcon A contact lenses worn first, with somofilcon 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. Somofilcon 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.
    Period Title: First Wear Period (8 -1/+2 Days)
    STARTED 76 75
    COMPLETED 76 75
    NOT COMPLETED 0 0
    Period Title: First Wear Period (8 -1/+2 Days)
    STARTED 74 75
    COMPLETED 73 74
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title DDT2, Then Clariti Clariti, Then DDT2 Total
    Arm/Group Description Verofilcon A contact lenses worn first, with somofilcon 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. Verofilcon A contact lenses: Investigational daily disposable soft contact lenses Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses Somofilcon 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. Verofilcon A contact lenses: Investigational daily disposable soft contact lenses Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses Total of all reporting groups
    Overall Participants 76 75 151
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    35.1
    (7.9)
    31.8
    (7.9)
    33.5
    (8.1)
    Sex: Female, Male (Count of Participants)
    Female
    56
    73.7%
    47
    62.7%
    103
    68.2%
    Male
    20
    26.3%
    28
    37.3%
    48
    31.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    3.9%
    6
    8%
    9
    6%
    Not Hispanic or Latino
    73
    96.1%
    69
    92%
    142
    94%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    65
    85.5%
    67
    89.3%
    132
    87.4%
    Black or African American
    5
    6.6%
    1
    1.3%
    6
    4%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    1.3%
    0
    0%
    1
    0.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Other
    1
    1.3%
    2
    2.7%
    3
    2%
    Multi-racial
    1
    1.3%
    0
    0%
    1
    0.7%
    Region of Enrollment (participants) [Number]
    United States
    76
    100%
    75
    100%
    151
    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/eyes with non-missing responses, 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 Clariti
    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. Somofilcon 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 151 149
    Measure eyes 294 296
    Least Squares Mean (Standard Error) [logMAR]
    -0.08
    (0.006)
    -0.08
    (0.006)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DDT2, Clariti
    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 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference = DDT2 - Clariti

    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 Clariti - Ocular Clariti - 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. Somofilcon 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. Somofilcon 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 Clariti - Ocular Clariti - Systemic / Nonocular
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/302 (0%) 0/151 (0%) 0/298 (0%) 0/149 (0%)
    Serious Adverse Events
    DDT2 - Ocular DDT2 - Systemic / Nonocular Clariti - Ocular Clariti - Systemic / Nonocular
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/302 (0%) 0/151 (0%) 0/298 (0%) 0/149 (0%)
    Other (Not Including Serious) Adverse Events
    DDT2 - Ocular DDT2 - Systemic / Nonocular Clariti - Ocular Clariti - Systemic / Nonocular
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/302 (0%) 0/151 (0%) 0/298 (0%) 0/149 (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:
    NCT03888482
    Other Study ID Numbers:
    • CLE383-C010
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Jul 13, 2020
    Last Verified:
    Jun 1, 2020