Trial Outcomes & Findings for Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses (NCT NCT05886907)

Last Updated: 2024-07-31

Results Overview

Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Day 2, each wear period. A wear period was approximately 2 days.

Results posted on

2024-07-31

Participant Flow

Participants were recruited from 1 investigative site located in the United States.

Of the 18 enrolled, 9 were exited prior to study lens assignment as screen failures. This reporting group includes all participants exposed to any study lenses evaluated in this study (9).

Participant milestones

Participant milestones
Measure	LID223188, Then Ultra MFT Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	Ultra MFT, Then LID223188 Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.
First Wear Period (Approx. 2 Days) STARTED	5	4
First Wear Period (Approx. 2 Days) COMPLETED	5	4
First Wear Period (Approx. 2 Days) NOT COMPLETED	0	0
Second Wear Period (Approx. 2 Days) STARTED	5	4
Second Wear Period (Approx. 2 Days) COMPLETED	5	4
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 Toric Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID223188, Then Ultra MFT n=5 Participants Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	Ultra MFT, Then LID223188 n=4 Participants Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product was worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	Total n=9 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 10.0 • n=5 Participants	65.0 years STANDARD_DEVIATION 3.2 • n=7 Participants	61.4 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	4 Participants n=7 Participants	5 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	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2, each wear period. A wear period was approximately 2 days.

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