Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

Not Applicable

Completed

Conditions: Refractive Ametropia

Interventions: Device: Lehfilcon A multifocal contact lenses
Device: Lotrafilcon B multifocal contact lenses
Device: Hydrogen peroxide-based cleaning and disinfection system

Registration Number: NCT05765227

Lead Sponsor: Alcon Research

Brief Summary: The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Detailed Description: Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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
LID#224381, then AOHG MF	Hydrogen peroxide-based cleaning and disinfection system	Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
AOHG MF, then LID#224381	Lehfilcon A multifocal contact lenses	Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
LID#224381, then AOHG MF	Lehfilcon A multifocal contact lenses	Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
LID#224381, then AOHG MF	Lotrafilcon B multifocal contact lenses	Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
AOHG MF, then LID#224381	Lotrafilcon B multifocal contact lenses	Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
AOHG MF, then LID#224381	Hydrogen peroxide-based cleaning and disinfection system	Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)	Day 2, 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 prespecified for this endpoint.

Secondary Outcome Measures