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The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05766787
Collaborator
(none)
185
Enrollment
15
Locations
2
Arms
2
Anticipated Duration (Months)
12.3
Patients Per Site
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

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

Detailed Description

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
185 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: LID022821/AOHP

Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.

Device: Serafilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Other Names:
  • LID022821

    • Device: Senofilcon A contact lenses
    Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
    Other Names:
  • ACUVUE OASYS® with HYDRACLEAR® PLUS Technology
  • AOHP

    • Device: CLEAR CARE
    Hydrogen peroxide based contact lens cleaning and disinfecting solution
    Other Names:
  • CLEAR CARE® Cleaning and Disinfecting Solution

    		•
    Other: AOHP/LID022821

    Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.

    Device: Serafilcon A contact lenses
    Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
    Other Names:
  • LID022821

    • Device: Senofilcon A contact lenses
    Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
    Other Names:
  • ACUVUE OASYS® with HYDRACLEAR® PLUS Technology
  • AOHP

    • Device: CLEAR CARE
    Hydrogen peroxide based contact lens cleaning and disinfecting solution
    Other Names:
  • CLEAR CARE® Cleaning and Disinfecting Solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Distance VA with study lenses at Week 1 [Week 1, each study lens type]

      Visual acuity (VA) at distance will be assessed with study lenses in place and measured in logarithm minimum angle of resolution (logMAR). VA will be collected for each eye individually.

    Eligibility Criteria

    Criteria

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

    • Successful wear of 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 (0.10 logMAR) or better in each eye.

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

    • Other protocol-specific inclusion criteria may apply.

    Exclusion Criteria:

    • Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.

    • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.

    • Habitual wear of AOHP contact lenses.

    • Habitual wear of any daily disposable contact lenses.

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kurata Eyecare Center Los Angeles California United States 90013
    2 Dr. Elsa Pao, OD Oakland California United States 94607
    3 Pacific Rims Optometry San Francisco California United States 94127
    4 Omega Vision Center P.A. Longwood Florida United States 32779
    5 Kindred Optics at Maitland Vision Maitland Florida United States 32751
    6 Vision Health Institute Orlando Florida United States 32803
    7 Tallahassee Eye Center Tallahassee Florida United States 32308
    8 Heart of America Eye Care Shawnee Mission Kansas United States 66204
    9 The Eye Doctors Inc Eden Prairie Minnesota United States 55344
    10 Complete Eye Care of Medina Medina Minnesota United States 55340
    11 SUNY College of Optometry Clinical Vision Research Center New York New York United States 10036
    12 ProCare Vision Centers, Inc. Granville Ohio United States 43023
    13 West Bay Eye Associates Warwick Rhode Island United States 02888
    14 Optometry Group, PLLC Memphis Tennessee United States 38111
    15 Total Eye Care PA Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Alcon Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05766787
    Other Study ID Numbers:
    • CLL949-C024
    First Posted:
    Mar 13, 2023
    Last Update Posted:
    Mar 13, 2023
    Last Verified:
    Mar 1, 2023
    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
    myopia
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Mar 13, 2023