Clincosm LogoSign in Get a demo

Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT05010512
Collaborator
(none)
112
Enrollment
8
Locations
2
Arms
1.4
Actual Duration (Months)
14
Patients Per Site
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Delefilcon A contact lenses
  • Device: Kalifilcon A contact lenses
 N/A

Detailed Description

Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Actual Study Start Date :
Aug 31, 2021
Actual Primary Completion Date :
Oct 12, 2021
Actual Study Completion Date :
Oct 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: DT1, then Infuse

Delefilcon A contact lenses worn first, followed by kalifilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.

Device: Delefilcon A contact lenses
Commercially available silicone hydrogel contact lenses used as indicated
Other Names:
  • DAILIES TOTAL1®
  • DT1

    • Device: Kalifilcon A contact lenses
    Commercially available silicone hydrogel contact lenses used as indicated
    Other Names:
  • Bausch + Lomb INFUSE™
  • Infuse

    		•
    Active Comparator: Infuse, then DT1

    Kalifilcon A contact lenses worn first, followed by delefilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.

    Device: Delefilcon A contact lenses
    Commercially available silicone hydrogel contact lenses used as indicated
    Other Names:
  • DAILIES TOTAL1®
  • DT1

    • Device: Kalifilcon A contact lenses
    Commercially available silicone hydrogel contact lenses used as indicated
    Other Names:
  • Bausch + Lomb INFUSE™
  • Infuse

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Distance VA (logMAR) with study lenses [Day 8 (-0/+3), each product]

      Visual acuity will be assessed with letter charts

    Eligibility Criteria

    Criteria

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

    • Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;

    • At least 3 months of contact lens wearing experience;

    • Less than or equal to 0.75 diopter (D) astigmatism in each eye;

    • Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.

    • Other protocol-defined inclusion criteria may apply.

    Key Exclusion Criteria:

    • Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;

    • Monovision and/or multifocal lens wearer;

    • Routinely sleeps in habitual contact lenses;

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigator 6355 Orlando Florida United States 32803
    2 Alcon Investigator 6418 Tallahassee Florida United States 32308
    3 Alcon Investigator 3950 Bloomington Illinois United States 61704
    4 Alcon Investigator 6614 Franklin Park Illinois United States 60131
    5 Alcon Investigator 6583 Eden Prairie Minnesota United States 55344
    6 Alcon Investigator 3382 Wyomissing Pennsylvania United States 19610
    7 Alcon Investigator 6353 Memphis Tennessee United States 38111
    8 Alcon Investigator 2786 Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05010512
    Other Study ID Numbers:
    • CLU484-P002
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    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
    Contact lenses
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Oct 19, 2021