Trial Outcomes & Findings for Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens (NCT NCT04178720)

Last Updated: 2021-10-19

Results Overview

Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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 formal hypothesis testing was planned.

Recruitment status

COMPLETED

Study phase

Target enrollment

119 participants

Primary outcome timeframe

Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

Results posted on

2021-10-19

Participant Flow

Subjects were enrolled at 8 investigative sites located in the US.

Of the 119 enrolled, 1 subject was screen failed. This reporting group includes all enrolled and dispensed subjects/eyes (118/236).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Biofinity Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.	LID018869 Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Overall Study STARTED	40 80	78 156
Overall Study COMPLETED	38 76	77 154
Overall Study NOT COMPLETED	2 4	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Biofinity Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.	LID018869 Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Overall Study Withdrawal by Subject	2	0
Overall Study Relocation	0	1

Baseline Characteristics

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofinity n=40 Participants Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.	LID018869 n=78 Participants Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.	Total n=118 Participants Total of all reporting groups
Age, Continuous	32.9 years STANDARD_DEVIATION 7.3 • n=5 Participants	34.4 years STANDARD_DEVIATION 7.6 • n=7 Participants	33.9 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	57 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	21 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	74 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	65 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	78 participants n=7 Participants	118 participants n=5 Participants

PRIMARY outcome

Timeframe: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

Population: This analysis population includes all enrolled and dispensed subjects/eyes that completed the study with data at corresponding in-person visit.

Outcome measures

Outcome measures
Measure	Biofinity n=76 eyes Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours onl, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.	LID018869 n=154 eyes Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Distance VA (logMAR) With Study Lenses - Completed Eyes Dispense	-0.07 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.06
Distance VA (logMAR) With Study Lenses - Completed Eyes Week 1 follow-up	-0.08 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.06
Distance VA (logMAR) With Study Lenses - Completed Eyes Week 2 follow-up Snellen	-0.07 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.06
Distance VA (logMAR) With Study Lenses - Completed Eyes Month 1 follow-up	-0.07 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.06
Distance VA (logMAR) With Study Lenses - Completed Eyes Month 2 follow-up	-0.06 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.07
Distance VA (logMAR) With Study Lenses - Completed Eyes Month 3 follow-up	-0.07 logMAR Standard Deviation 0.06	-0.06 logMAR Standard Deviation 0.11

PRIMARY outcome

Timeframe: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up

Population: This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early with data at corresponding in-person visit.