Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Not Applicable

Completed

Conditions: Refractive Errors

Interventions: Device: Lehfilcon A contact lenses
Device: Senofilcon A contact lenses
Device: CLEAR CARE

Registration Number: NCT05050578

Lead Sponsor: Alcon Research

Brief Summary: The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Detailed Description: Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 166

Inclusion Criteria

Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
Manifest cylinder less than or equal to 0.75 diopter in each eye.
Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

Monovision or multifocal lens wearer.
Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
Routinely sleeps in habitual contact lenses.
Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LID018869, then AOHP	CLEAR CARE	Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
AOHP, then LID018869	Senofilcon A contact lenses	Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
AOHP, then LID018869	CLEAR CARE	Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
LID018869, then AOHP	Lehfilcon A contact lenses	Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
LID018869, then AOHP	Senofilcon A contact lenses	Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.
AOHP, then LID018869	Lehfilcon A contact lenses	Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30	Day 30, each study lens type	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (10): Dr. Elsa Pao, OD
🇺🇸
Oakland, California, United States
Sabal Eye Care
🇺🇸
Longwood, Florida, United States
West Bay Eye Associates
🇺🇸
Warwick, Rhode Island, United States
Vision Health Institute
🇺🇸
Orlando, Florida, United States
North Spartanburg Eye Center
🇺🇸
Boiling Springs, South Carolina, United States
Optometry Group, PLLC
🇺🇸
Memphis, Tennessee, United States
Advancing Vision Research, LLC
🇺🇸
Smyrna, Tennessee, United States
Dr Christina R Chang & Associates, OD, PA
🇺🇸
Plano, Texas, United States
Pacific Rims Optometry
🇺🇸
San Francisco, California, United States
Dawn M. Rakich, OD
🇺🇸
San Antonio, Texas, United States