Trial Outcomes & Findings for Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens (NCT NCT04476784)

Last Updated: 2021-10-26

Results Overview

Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. 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

66 participants

Primary outcome timeframe

Day 1, Day 30 after 6-8 hours of wear, each product

Results posted on

2021-10-26

Participant Flow

Subjects were enrolled at 5 investigative sites located in the United States.

This reporting group includes all subjects/eyes (66/132) exposed to any study lenses evaluated in this study as treated (Safety Analysis Set)

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID018869, Then Biofinity Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Biofinity, Then LID018869 Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
First Wear Period (30 Days ± 2 Days) STARTED	31 62	35 70
First Wear Period (30 Days ± 2 Days) COMPLETED	30 60	35 70
First Wear Period (30 Days ± 2 Days) NOT COMPLETED	1 2	0 0
Second Wear Period (30 Days ± 2 Days) STARTED	30 60	35 70
Second Wear Period (30 Days ± 2 Days) COMPLETED	30 60	35 70
Second Wear Period (30 Days ± 2 Days) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	LID018869, Then Biofinity Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Biofinity, Then LID018869 Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
First Wear Period (30 Days ± 2 Days) Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID018869, Then Biofinity n=31 Participants Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Biofinity, Then LID018869 n=35 Participants Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Total n=66 Participants Total of all reporting groups
Age, Continuous	32.6 years STANDARD_DEVIATION 8.0 • n=5 Participants	33.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	33.2 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 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	31 Participants n=5 Participants	35 Participants n=7 Participants	66 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	35 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 30 after 6-8 hours of wear, each product

Population: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.