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Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT05039112
Collaborator
(none)
64
Enrollment
6
Locations
2
Arms
2
Actual Duration (Months)
10.7
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

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

Detailed Description

Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
Actual Study Start Date :
Sep 28, 2021
Actual Primary Completion Date :
Nov 29, 2021
Actual Study Completion Date :
Nov 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: P1fA, then MyDay Toric

Verofilcon A toric contact lenses worn first, with stenfilcon 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, used as indicated
Other Names:
  • PRECISION1 for Astigmatism
  • P1fA

    • Device: Stenfilcon A toric contact lenses
    Soft contact lenses for optical correction of astigmatism, used as indicated
    Other Names:
  • MyDay Toric

    		•
    Other: MyDay Toric, then P1fA

    Stenfilcon 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, used as indicated
    Other Names:
  • PRECISION1 for Astigmatism
  • P1fA

    • Device: Stenfilcon A toric contact lenses
    Soft contact lenses for optical correction of astigmatism, used as indicated
    Other Names:
  • MyDay Toric

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion [Day 1, 10 minutes after lens insertion, each product]

      Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key 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.

    • Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.

    • Other protocol-defined inclusion criteria may apply.

    Key Exclusion Criteria:

    • Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.

    • Current wear of spherical contact lenses.

    • Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).

    • 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 6567 Pittsburg Kansas United States 66762
    3 Alcon Investigator 8097 Sterling Heights Michigan United States 48312
    4 Alcon Investigator 6313 Powell Ohio United States 43065
    5 Alcon Investigator 6401 Warwick Rhode Island United States 02888
    6 Alcon Investigator 6353 Memphis Tennessee United States 38111

    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:
    NCT05039112
    Other Study ID Numbers:
    • CLA306-E001
    First Posted:
    Sep 9, 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:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alcon Research
    Contact lenses
    Daily disposable
    Additional relevant MeSH terms:
    Astigmatism
    Refractive Errors

    Study Results

    No Results Posted as of Dec 7, 2021