Trial Outcomes & Findings for Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses (NCT NCT05702541)

Last Updated: 2024-03-26

Results Overview

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 pre-specified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Day 2 of each study lens type worn during the corresponding crossover period

Results posted on

2024-03-26

Participant Flow

Participants were recruited from one investigative site located in the United States.

This reporting group includes all enrolled participants (16).

Participant milestones

Participant milestones
Measure	LID223194 MF, Then AOHG MF Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection.	AOHG MF, Then LID223194 MF Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection.
First Wear Period (Approx 2 Days) STARTED	8	8
First Wear Period (Approx 2 Days) COMPLETED	8	8
First Wear Period (Approx 2 Days) NOT COMPLETED	0	0
Second Wear Period (Approx 2 Days) STARTED	8	8
Second Wear Period (Approx 2 Days) COMPLETED	8	8
Second Wear Period (Approx 2 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID223194 MF, Then AOHG MF n=8 Participants Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection.	AOHG MF, Then LID223194 MF n=8 Participants Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product was worn in both eyes for 2 days in a daily wear modality. CLEAR CARE was used for daily cleaning and disinfection.	Total n=16 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 3.4 • n=5 Participants	60.4 years STANDARD_DEVIATION 8.0 • n=7 Participants	60.3 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2 of each study lens type worn during the corresponding crossover period

Population: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.