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Status:

COMPLETED

Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Lead Sponsor:

Alcon Research

Conditions:

Refractive Errors

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Detailed Description

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Sign Informed Consent document.
  • Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
  • Other protocol-specified inclusion criteria may apply.
  • Exclusion Criteria
  • Any eye condition or disease or use of medication that contraindicates contact lens wear.
  • Eye surgery, irregular cornea, eye injury as specified in the protocol.
  • Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
  • Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
  • Habitually wears Biofinity contact lenses.
  • Other protocol-specified exclusion criteria may apply.

Exclusion

    Key Trial Info

    Start Date :

    September 19 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 3 2019

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT04055519

    Start Date

    September 19 2019

    End Date

    December 3 2019

    Last Update

    May 13 2021

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Alcon Investigative Site

    Maitland, Florida, United States, 32751

    2

    Alcon Investigative Site

    Bloomington, Illinois, United States, 61704

    3

    Alcon Investigative Site

    Memphis, Tennessee, United States, 38111