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

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lehfilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses; Device: CLEAR CARE®

• Registration Number: NCT05338333
• Lead Sponsor: Alcon Research

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.

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 Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-21
• Study Start: 2022-05-27
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-08
• Results First Submitted: 2023-08-23
• Results First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AOHG MF, then LID210464	CLEAR CARE®	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.
LID210464, then AOHG MF	Lehfilcon A multifocal contact lenses	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.
LID210464, then AOHG MF	Lotrafilcon B multifocal contact lenses	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.
AOHG MF, then LID210464	Lehfilcon A multifocal contact lenses	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.
AOHG MF, then LID210464	Lotrafilcon B multifocal contact lenses	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.
LID210464, then AOHG MF	CLEAR CARE®	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.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses	Day 30, each wear period. A wear period was approximately 30 days.	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.

Trial Locations

Locations (8)

Kindred Optics at Maitland Vision; 🇺🇸 Maitland, Florida, United States

Optometry Group, PLLC; 🇺🇸 Memphis, Tennessee, United States

Vision Health Institute; 🇺🇸 Orlando, Florida, United States

Kannarr Eye Care LLC; 🇺🇸 Pittsburg, Kansas, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

The Eye Doctors, Inc.; 🇺🇸 Eden Prairie, Minnesota, United States

West Bay Eye Associates; 🇺🇸 Warwick, Rhode Island, United States

ProCare Vision Centers, Inc.; 🇺🇸 Granville, Ohio, United States