Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Not Applicable

Completed

Conditions: Refractive Errors

Interventions: Device: Lehfilcon A contact lenses
Device: Comfilcon A contact lenses
Device: Multi-purpose disinfection solution

Registration Number: NCT04055519

Lead Sponsor: Alcon Research

Brief Summary: The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Detailed Description: Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

Inclusion Criteria

Sign Informed Consent document.
Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

Any eye condition or disease or use of medication that contraindicates contact lens wear.
Eye surgery, irregular cornea, eye injury as specified in the protocol.
Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
Habitually wears Biofinity contact lenses.
Other protocol-specified exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biofinity, then LID017569	Lehfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Biofinity, then LID017569	Comfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
LID017569, then Biofinity	Multi-purpose disinfection solution	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
LID017569, then Biofinity	Lehfilcon A contact lenses	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
Biofinity, then LID017569	Multi-purpose disinfection solution	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.
LID017569, then Biofinity	Comfilcon A contact lenses	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Distance VA (logMAR) With Study Lenses	Day 30 after a minimum of 6 hours of wear, each product	Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Secondary Outcome Measures