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Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04942925
Collaborator
(none)
60
Enrollment
4
Locations
2
Arms
1.7
Actual Duration (Months)
15
Patients Per Site
9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the overall performance of 2 new daily disposable contact lenses.

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

Detailed Description

The expected duration of subject participation in the study is up to 24 days, with 3 scheduled visits.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Subjects will receive treatment based upon the randomized treatment sequence assignmentSubjects will receive treatment based upon the randomized treatment sequence assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Actual Study Start Date :
Jul 20, 2021
Actual Primary Completion Date :
Sep 9, 2021
Actual Study Completion Date :
Sep 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Precision1, then Infuse

Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Device: Verofilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • PRECISION1™

    • Device: Kalifilcon A contact lenses
    Commercially available silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • Bausch + Lomb INFUSE™

    		•
    Other: Infuse, then Precision1

    Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

    Device: Verofilcon A contact lenses
    Commercially available silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • PRECISION1™

    • Device: Kalifilcon A contact lenses
    Commercially available silicone hydrogel contact lenses for daily disposable wear
    Other Names:
  • Bausch + Lomb INFUSE™

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Distance VA with study lenses will be collected in logarithm Minimum Angle of Resolution (logMAR) for each eye.

    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 been approved by an Institutional Review Board.

    • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.

    • Willing to wear study contact lenses for at least 16 hours prior to the follow up visits.

    • Other protocol-defined inclusion criteria may apply.

    Key Exclusion Criteria:

    • Current/previous PRECISION1 or INFUSE contact lens wearer.

    • Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.

    • Routinely sleeps in contact lenses.

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigator 6565 Maitland Florida United States 32751
    2 Alcon Investigator 6355 Orlando Florida United States 32803
    3 Alcon Investigator 6583 Eden Prairie Minnesota United States 55344
    4 Alcon Investigator 6313 Powell Ohio United States 43065

    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:
    NCT04942925
    Other Study ID Numbers:
    • CLE383-E002
    First Posted:
    Jun 29, 2021
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 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 Sep 21, 2021