Trial Outcomes & Findings for Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens (NCT NCT05211739)

Last Updated: 2023-06-27

Results Overview

Visual acuity (VA) was collected for each eye individually with study lenses in place 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. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

Day 1 and Day 30, each wear period (approximately 30 days)

Results posted on

2023-06-27

Participant Flow

Participants were recruited from 7 investigative sites located in the United States.

Of the 76 subjects enrolled in the study (i.e., signed informed consent), 2 subjects were exited prior to randomization as screen failures, and 1 randomized subject withdrew prior to exposure to the study lenses. This reporting group includes all randomized subjects/eyes (74/148).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID205255 Toric, Then Biofinity Toric Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Biofinity Toric, Then LID205255 Toric Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
First Wear Period (Approx 30 Days) STARTED	36 72	38 76
First Wear Period (Approx 30 Days) Exposed to Study Lenses	35 70	38 76
First Wear Period (Approx 30 Days) COMPLETED	35 70	36 72
First Wear Period (Approx 30 Days) NOT COMPLETED	1 2	2 4
Second Wear Period (Approx 30 Days) STARTED	35 70	36 72
Second Wear Period (Approx 30 Days) COMPLETED	34 68	36 72
Second Wear Period (Approx 30 Days) NOT COMPLETED	1 2	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	LID205255 Toric, Then Biofinity Toric Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Biofinity Toric, Then LID205255 Toric Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
First Wear Period (Approx 30 Days) Adverse Event	0	1
First Wear Period (Approx 30 Days) Withdrawal by Subject Prior to Exposure to the Study Lenses	1	0
First Wear Period (Approx 30 Days) Withdrawal by Subject	0	1
Second Wear Period (Approx 30 Days) Adverse Event	1	0

Baseline Characteristics

Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID205255 Toric, Then Biofinity Toric n=36 Participants Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Biofinity Toric, Then LID205255 Toric n=38 Participants Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Total n=74 Participants Total of all reporting groups
Age, Continuous	32.9 year STANDARD_DEVIATION 8.3 • n=93 Participants	35.8 year STANDARD_DEVIATION 10.2 • n=4 Participants	34.4 year STANDARD_DEVIATION 9.4 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	25 Participants n=4 Participants	51 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	13 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=93 Participants	32 Participants n=4 Participants	65 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Missing	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 30, each wear period (approximately 30 days)

Population: All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing data at the respective visit.