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Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06044948
Collaborator
(none)
96
Enrollment
4
Locations
1
Arm
1
Anticipated Duration (Months)
24
Patients Per Site
23.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

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

Detailed Description

Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
In this single arm study, the subject will be masked to the lens type.
Primary Purpose:
Treatment
Official Title:
Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DAILIES TOTAL1

Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner.

Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel spherical contact lenses
Other Names:
  • DAILIES TOTAL1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Distance VA with study lenses at Week 1 [Week 1]

      Visual acuity (VA) will be measured with study lenses on eye using letter charts. VA will be recorded in Snellen where 20/20 represents normal distance eyesight.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    • Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;

    • Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;

    • Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

    Key Exclusion Criteria:

    • Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;

    • Monovision contact lens wear;

    • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Eye Doctors, Inc. Eden Prairie Minnesota United States 55344
    2 ProCare Vision Center Granville Ohio United States 43023
    3 Wyomissing Optometric Center Wyomissing Pennsylvania United States 19610
    4 Optometry Group, PLLC Memphis Tennessee United States 38111

    Sponsors and Collaborators

    • Alcon Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT06044948
    Other Study ID Numbers:
    • CLU484-P003
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 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
    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, 2023