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Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04980456
Collaborator
(none)
257
Enrollment
14
Locations
2
Arms
3.5
Actual Duration (Months)
18.4
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Condition or Disease Intervention/Treatment Phase
  • Device: Lehfilcon A contact lenses
  • Device: Comfilcon A contact lenses
  • Device: CLEAR CARE
 N/A

Detailed Description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days (which includes 30 days for each product).

Study Design

Study Type:
Interventional
Actual Enrollment :
257 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Actual Study Start Date :
Aug 5, 2021
Actual Primary Completion Date :
Nov 20, 2021
Actual Study Completion Date :
Nov 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: TOTAL30, then Biofinity

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for nightly cleaning and disinfection.

Device: Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
Other Names:
  • TOTAL30

    • Device: Comfilcon A contact lenses
    Commercially available silicone hydrogel contact lenses
    Other Names:
  • CooperVision® Biofinity®
  • Biofinity

    • Device: CLEAR CARE
    Hydrogen peroxide-based cleaning and disinfecting solution
    Other: Biofinity, then TOTAL30

    Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for nightly cleaning and disinfection.

    Device: Lehfilcon A contact lenses
    Investigational silicone hydrogel contact lenses
    Other Names:
  • TOTAL30

    • Device: Comfilcon A contact lenses
    Commercially available silicone hydrogel contact lenses
    Other Names:
  • CooperVision® Biofinity®
  • Biofinity

    • Device: CLEAR CARE
    Hydrogen peroxide-based cleaning and disinfecting solution

    Outcome Measures

    Primary Outcome Measures

    1. Distance Visual Acuity (logMAR) with study lenses [Day 30, 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
    Inclusion Criteria:

    • Able to understand and sign an approved Informed Consent form;

    • Willing and able to attend all scheduled study visits as required by the protocol;

    • Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;

    • Manifest cylinder less than or equal to 0.75 diopter (D) 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 that contraindicates contact lens wear, as determined by the Investigator;

    • Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;

    • Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;

    • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

    • Current or prior Biofinity contact lens wear in the past 3 months prior to consent.

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigator 8135 Los Angeles California United States 90012
    2 Alcon Investigator 8062 Oakland California United States 94607
    3 Alcon Investigator 8106 San Francisco California United States 94127
    4 Alcon Investigator 6356 Longwood Florida United States 32779
    5 Alcon Investigator 6565 Maitland Florida United States 32751
    6 Alcon Investigator 6654 West Palm Beach Florida United States 33405
    7 Alcon Investigator 6567 Pittsburg Kansas United States 66762
    8 Alcon Investigator 5582 Louisville Kentucky United States 40206
    9 Alcon Investigator 8097 Sterling Heights Michigan United States 48312
    10 Alcon Investigator 7980 Willmar Minnesota United States 56201
    11 Alcon Investigator 8130 New York New York United States 10036
    12 Alcon Investigator 6401 Warwick Rhode Island United States 02888
    13 Alcon Investigator 6353 Memphis Tennessee United States 38111
    14 Alcon Investigator 8175 Austin Texas United States 78731

    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:
    NCT04980456
    Other Study ID Numbers:
    • CLY935-C019
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 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:
    Myopia

    Study Results

    No Results Posted as of Dec 7, 2021