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Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04908488
Collaborator
(none)
115
Enrollment
8
Locations
2
Arms
2.7
Actual Duration (Months)
14.4
Patients Per Site
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

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

Detailed Description

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. On one of the days on/after Day 7 of study lens wear and prior to each Week 1 Follow-up visit, subjects will be asked to wear the respective study lens for at least 16 hours. The total duration of subject participation will be up to 22 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Sep 22, 2021
Actual Study Completion Date :
Sep 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: P1fA, then AMfA

Verofilcon A toric contact lenses worn first, with etafilcon A toric 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 toric contact lenses
Soft contact lenses for optical correction of astigmatism
Other Names:
  • PRECISION1™ for Astigmatism
  • P1fA

    • Device: Etafilcon A toric contact lenses
    Soft contact lenses for optical correction of astigmatism
    Other Names:
  • 1-DAY ACUVUE MOIST® for ASTIGMATISM
  • AMfA

    		•
    Other: AMfA, then P1fA

    Etafilcon A toric contact lenses worn first, with verofilcon A toric 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 toric contact lenses
    Soft contact lenses for optical correction of astigmatism
    Other Names:
  • PRECISION1™ for Astigmatism
  • P1fA

    • Device: Etafilcon A toric contact lenses
    Soft contact lenses for optical correction of astigmatism
    Other Names:
  • 1-DAY ACUVUE MOIST® for ASTIGMATISM
  • AMfA

    		•

    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
    Inclusion Criteria:

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

    • Subject must be willing to wear study contact lenses for at least 16 hours per day on one of the days (must wear for 16 hours on/after Day 7 of wear of study lenses prior to each follow up visit).

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for Astigmatism contact lens wearers.

    • Any spherical monovision and multifocal lens wearers.

    • Wearing habitual contact lenses when sleeping for at least 1 night per week over 3 months prior to enrollment.

    • 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 6355 Orlando Florida United States 32803
    4 Alcon Investigator 6614 Franklin Park Illinois United States 60131
    5 Alcon Investigator 6645 Shawnee Mission Kansas United States 66204
    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:
    NCT04908488
    Other Study ID Numbers:
    • CLA306-P001
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Oct 5, 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
    Disposable
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Oct 5, 2021