Trial Outcomes & Findings for Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses (NCT NCT06469242)

Last Updated: 2025-10-09

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). No hypothesis testing was pre-specified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment.

Results posted on

2025-10-09

Participant Flow

Subjects were enrolled at 8 investigative sites.

Of the 106 subjects enrolled, 2 subjects were discontinued prior to exposure to the study product. This reporting group population includes all subjects exposed to any study lenses evaluated in this study.

Participant milestones

Participant milestones
Measure	LID233309, Then Oasys MF Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection.	Oasys MF, Then LID233309 Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection.
First Wear Period (Approx 14 Days) STARTED	53	51
First Wear Period (Approx 14 Days) COMPLETED	48	47
First Wear Period (Approx 14 Days) NOT COMPLETED	5	4
Second Wear Period (Approx 14 Days) STARTED	48	47
Second Wear Period (Approx 14 Days) COMPLETED	48	47
Second Wear Period (Approx 14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LID233309, Then Oasys MF Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection.	Oasys MF, Then LID233309 Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection.
First Wear Period (Approx 14 Days) Protocol Violation	4	3
First Wear Period (Approx 14 Days) As Per Sponsor Guidance	1	1

Baseline Characteristics

Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID233309, Then Oasys MF n=53 Participants Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection.	Oasys MF, Then LID233309 n=51 Participants Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses were worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period was 14 days (-0/+2). CLEAR CARE was used for daily cleaning and disinfection.	Total n=104 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 7.0 • n=99 Participants	53.5 years STANDARD_DEVIATION 6.7 • n=107 Participants	52.8 years STANDARD_DEVIATION 6.9 • n=206 Participants
Sex: Female, Male Female	35 Participants n=99 Participants	37 Participants n=107 Participants	72 Participants n=206 Participants
Sex: Female, Male Male	18 Participants n=99 Participants	14 Participants n=107 Participants	32 Participants n=206 Participants
Race/Ethnicity, Customized White	37 participants n=99 Participants	37 participants n=107 Participants	74 participants n=206 Participants
Race/Ethnicity, Customized Black or African American	2 participants n=99 Participants	1 participants n=107 Participants	3 participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Race/Ethnicity, Customized Asian	14 participants n=99 Participants	11 participants n=107 Participants	25 participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Race/Ethnicity, Customized Other	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Multi-Racial	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=99 Participants	2 participants n=107 Participants	5 participants n=206 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	50 participants n=99 Participants	49 participants n=107 Participants	99 participants n=206 Participants
Region of Enrollment United States	53 participants n=99 Participants	51 participants n=107 Participants	104 participants n=206 Participants

PRIMARY outcome

Timeframe: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment.

Population: Full Analysis Set with data at visit