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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lehfilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses; Device: CLEAR CARE®

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Kindred Optics at Maitland Vision
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care LLC
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • The Eye Doctors, Inc.
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers, Inc.
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses	Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 30, each wear period. A wear period was approximately 30 days.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Contact lenses; Multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CLN705-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes