Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05338333
Collaborator
(none)
101
8
2
2.2
12.6
5.8

Study Details

Study Description

Brief Summary

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

Condition or Disease Intervention/Treatment Phase
  • Device: Lehfilcon A multifocal contact lenses
  • Device: Lotrafilcon B multifocal contact lenses
  • Device: CLEAR CARE®
N/A

Detailed Description

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Actual Study Start Date :
May 27, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: LID210464, then AOHG MF

Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Device: Lehfilcon A multifocal contact lenses
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Other Names:
  • LID210464
  • Device: Lotrafilcon B multifocal contact lenses
    Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
    Other Names:
  • AOHG MF
  • AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses
  • Device: CLEAR CARE®
    Hydrogen peroxide-based contact lens cleaning and disinfecting solution

    Other: AOHG MF, then LID210464

    Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

    Device: Lehfilcon A multifocal contact lenses
    Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
    Other Names:
  • LID210464
  • Device: Lotrafilcon B multifocal contact lenses
    Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
    Other Names:
  • AOHG MF
  • AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses
  • Device: CLEAR CARE®
    Hydrogen peroxide-based contact lens cleaning and disinfecting solution

    Outcome Measures

    Primary Outcome Measures

    1. Binocular high contrast/high illumination visual acuity at distance [Day 30, each study lens type]

      Visual acuity (VA) with the contact lenses in place will be assessed under high contrast, high illumination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.

    • Willing and able to attend all study visits as required by the protocol.

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

    • Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.

    • Other protocol-specified inclusion criteria may apply.

    Key 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.

    • History of refractive surgery or planning to have refractive surgery during the study.

    • Current or history of pathologically dry eye.

    • Currently pregnant or lactating.

    • Other protocol-specified 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 6355 Orlando Florida United States 32803
    3 Alcon Investigator 6567 Pittsburg Kansas United States 66762
    4 Alcon Investigator 6583 Eden Prairie Minnesota United States 55344
    5 Alcon Investigator 6402 Medina Minnesota United States 55340
    6 Alcon Investigator 8046 Granville Ohio United States 43023
    7 Alcon Investigator 6401 Warwick Rhode Island United States 02888
    8 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:
    NCT05338333
    Other Study ID Numbers:
    • CLN705-C001
    First Posted:
    Apr 21, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2022