Trial Outcomes & Findings for Clinical Performance of Two Daily Disposable Soft Contact Lenses (NCT NCT05138783)

Last Updated: 2023-04-18

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 of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

Day 8 (-0/+3 days), each study lens type

Results posted on

2023-04-18

Participant Flow

Subjects were recruited from 8 investigative sites in the US.

Of the 129 enrolled, 3 subjects were screen failures prior to randomization. This reporting group includes all randomized subjects, as treated (126).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	PRECISION1, Then Biotrue Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day.	Biotrue, Then PRECISION1 Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day.
First Wear Period, 8 -0/+3 Days STARTED	62 124	64 128
First Wear Period, 8 -0/+3 Days COMPLETED	62 124	64 128
First Wear Period, 8 -0/+3 Days NOT COMPLETED	0 0	0 0
Second Wear Period, 8 -0/+3 Days STARTED	62 124	64 128
Second Wear Period, 8 -0/+3 Days COMPLETED	62 124	64 128
Second Wear Period, 8 -0/+3 Days NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Two Daily Disposable Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRECISION1, Then Biotrue n=62 Participants Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day.	Biotrue, Then PRECISION1 n=64 Participants Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day.	Total n=126 Participants Total of all reporting groups
Age, Continuous	31.4 years STANDARD_DEVIATION 8.2 • n=5 Participants	33.5 years STANDARD_DEVIATION 7.3 • n=7 Participants	32.4 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	58 Participants n=7 Participants	110 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	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing data	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8 (-0/+3 days), each study lens type

Population: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this clinical study with data at Day 8.