Trial Outcomes & Findings for Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses (NCT NCT06461455)

Last Updated: 2025-12-24

Results Overview

Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).

Recruitment status

COMPLETED

Study phase

Target enrollment

95 participants

Primary outcome timeframe

Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.

Results posted on

2025-12-24

Participant Flow

Subjects were enrolled at 11 investigative sites.

Of the 95 enrolled, 6 subjects were discontinued as screen failures prior to randomization, and 4 subjects were discontinued post randomization and prior to exposure to the study lenses. This reporting group includes all subjects exposed to any study lenses evaluated in this study.

Participant milestones

Participant milestones
Measure	LID230451, Then ULTRA MFfA Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE.	ULTRA MFfA, Then LID230451 Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE.
First Wear Period (Approx 30 Days) STARTED	46	39
First Wear Period (Approx 30 Days) COMPLETED	45	38
First Wear Period (Approx 30 Days) NOT COMPLETED	1	1
Washout Period (Approx 2-4 Days) STARTED	45	38
Washout Period (Approx 2-4 Days) COMPLETED	45	37
Washout Period (Approx 2-4 Days) NOT COMPLETED	0	1
Second Wear Period (Approx 30 Days) STARTED	45	37
Second Wear Period (Approx 30 Days) COMPLETED	45	37
Second Wear Period (Approx 30 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LID230451, Then ULTRA MFfA Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE.	ULTRA MFfA, Then LID230451 Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE.
First Wear Period (Approx 30 Days) Withdrawal by Subject	0	1
First Wear Period (Approx 30 Days) Screen failure	1	0
Washout Period (Approx 2-4 Days) Adverse Event	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID230451, Then ULTRA MFfA n=46 Participants Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE.	ULTRA MFfA, Then LID230451 n=39 Participants Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses were removed daily for cleaning and disinfection with CLEAR CARE.	Total n=85 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 9.4 • n=30 Participants	55.9 years STANDARD_DEVIATION 9.4 • n=30 Participants	55.9 years STANDARD_DEVIATION 9.4 • n=60 Participants
Sex: Female, Male Female	29 Participants n=30 Participants	27 Participants n=30 Participants	56 Participants n=60 Participants
Sex: Female, Male Male	17 Participants n=30 Participants	12 Participants n=30 Participants	29 Participants n=60 Participants
Race/Ethnicity, Customized White	39 Participants n=30 Participants	27 Participants n=30 Participants	66 Participants n=60 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=30 Participants	2 Participants n=30 Participants	4 Participants n=60 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race/Ethnicity, Customized Asian	5 Participants n=30 Participants	10 Participants n=30 Participants	15 Participants n=60 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race/Ethnicity, Customized Other	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Region of Enrollment United States	46 participants n=30 Participants	39 participants n=30 Participants	85 participants n=60 Participants

PRIMARY outcome

Timeframe: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.

Population: Full Analysis Set with data at visit