Assessing the Clinical Performance 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: Hydrogen peroxide-based cleaning and disinfection system

• Registration Number: NCT05702541
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

Detailed Description

Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

Study Timeline

• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-19
• Study Start: 2023-01-24
• Study First Posted: 2023-01-27
• Primary Completion: 2023-02-21
• Study Completion: 2023-02-21
• Status Verified: 2024-02
• Results First Submitted: 2024-02-02
• Results First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-27
• Results First Posted: 2024-02-28
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
• Willing to stop wearing habitual contact lenses for the duration of study participation;
• Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

• Any eye infection, inflammation, or 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 plan to have refractive surgery during the study;
• Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
• Monovision contact lens wear;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LID223194 MF, then AOHG MF	Lotrafilcon B multifocal contact lenses	Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.
AOHG MF, then LID223194 MF	Hydrogen peroxide-based cleaning and disinfection system	Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.
LID223194 MF, then AOHG MF	Lehfilcon A multifocal contact lenses	Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.
AOHG MF, then LID223194 MF	Lehfilcon A multifocal contact lenses	Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.
LID223194 MF, then AOHG MF	Hydrogen peroxide-based cleaning and disinfection system	Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.
AOHG MF, then LID223194 MF	Lotrafilcon B multifocal contact lenses	Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Mean Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)	Day 2 of each study lens type worn during the corresponding crossover period	VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was pre-specified for this endpoint.

Trial Locations

Locations (1)

Johns Creek Research Clinic; 🇺🇸 Johns Creek, Georgia, United States