Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03349632
Collaborator
(none)
68
3
3
1.2
22.7
18.6

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Condition or Disease Intervention/Treatment Phase
  • Device: verofilcon A contact lenses
  • Device: senofilcon A contact lenses
  • Device: stenfilcon A contact lenses
  • Device: etafilcon A contact lenses
N/A

Detailed Description

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Actual Study Start Date :
Jan 10, 2018
Actual Primary Completion Date :
Feb 16, 2018
Actual Study Completion Date :
Feb 16, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: DD T2/Oasys 1-Day

Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized

Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • DDT2
  • Device: senofilcon A contact lenses
    Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • ACUVUE OASYS® 1-Day with HydraLuxe™ Technology
  • Oasys 1-Day
  • Other: DD T2/MyDay

    Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

    Device: verofilcon A contact lenses
    Investigational spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • DDT2
  • Device: stenfilcon A contact lenses
    Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • MyDay®
  • MyDay
  • Other: DD T2/Moist

    Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

    Device: verofilcon A contact lenses
    Investigational spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • DDT2
  • Device: etafilcon A contact lenses
    Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • 1-Day ACUVUE® MOIST
  • Moist
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Quality of Vision [Day 8, each product]

      Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Able to understand and must sign an approved Informed Consent Form

    • Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months

    • Best Corrected Visual Acuity of 20/25 Snellen or better in each eye

    • Willing to stop wearing habitual contact lenses for the duration of study participation

    • Other protocol-defined inclusion criteria may apply

    Exclusion Criteria:
    • Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.

    • Routinely sleeps in habitual contact lenses

    • Currently wears Oasys 1-Day, MyDay, or Moist contact lenses

    • Other protocol-defined exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigative Site Maitland Florida United States 32751
    2 Alcon Investigative Site Pensacola Florida United States 32503
    3 Alcon Investigative Site Johns Creek Georgia United States 30097

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03349632
    Other Study ID Numbers:
    • CLE383-C004
    First Posted:
    Nov 21, 2017
    Last Update Posted:
    Feb 22, 2019
    Last Verified:
    Jan 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.:
    No
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from 3 investigational sites located in the United States.
    Pre-assignment Detail Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).
    Arm/Group Title DD T2/Oasys 1-Day (Sequence 1) Oasys 1-Day/DD T2 (Sequence 2) DD T2/MyDay (Sequence 3) MyDay/DD T2 (Sequence 4) DD T2/Moist (Sequence 5) Moist/DD T2 (Sequence 6)
    Arm/Group Description Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
    Period Title: Period 1, First Week of Wear
    STARTED 11 11 11 11 11 11
    COMPLETED 11 11 11 11 11 11
    NOT COMPLETED 0 0 0 0 0 0
    Period Title: Period 1, First Week of Wear
    STARTED 11 11 11 11 11 11
    COMPLETED 11 11 11 11 11 11
    NOT COMPLETED 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized.
    Overall Participants 66
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    32.9
    (9.1)
    Sex: Female, Male (Count of Participants)
    Female
    46
    69.7%
    Male
    20
    30.3%
    Race/Ethnicity, Customized (Count of Participants)
    White
    56
    84.8%
    Black or African American
    6
    9.1%
    American Indian or Alaska Native
    0
    0%
    Asian
    4
    6.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Overall Quality of Vision
    Description Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
    Time Frame Day 8, each product

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set
    Arm/Group Title DD T2 (Sequence 1 and 2) Oasys 1-Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
    Arm/Group Description Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week
    Measure Participants 22 22 22 22 22 22
    Mean (Standard Deviation) [units on a scale]
    8.5
    (1.4)
    9.2
    (1.3)
    8.8
    (1.8)
    9.4
    (0.8)
    9.2
    (1.1)
    8.8
    (1.7)

    Adverse Events

    Time Frame Dispense through study completion, an average of 2 weeks
    Adverse Event Reporting Description An adverse event (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 investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.
    Arm/Group Title DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
    Arm/Group Description Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week
    All Cause Mortality
    DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%)
    Serious Adverse Events
    DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%)
    Other (Not Including Serious) Adverse Events
    DD T2 (Sequence 1 and 2) Oasys 1- Day (Sequence 1 and 2) DD T2 (Sequence 3 and 4) MyDay (Sequence 3 and 4) DD T2 (Sequence 5 and 6) Moist (Sequence 5 and 6)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/22 (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 Senior Clinical Project Lead, GCRA - Vision Care
    Organization Alcon, A Novartis Division
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03349632
    Other Study ID Numbers:
    • CLE383-C004
    First Posted:
    Nov 21, 2017
    Last Update Posted:
    Feb 22, 2019
    Last Verified:
    Jan 1, 2019