Trial Outcomes & Findings for Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3 (NCT NCT04942925)

Last Updated: 2022-09-07

Results Overview

Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No inferential testing was pre-specified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2022-09-07

Participant Flow

Study participants were recruited from 4 investigative sites located in the United States.

This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Precision1, Then Infuse Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	Infuse, Then Precision1 Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
First Wear Period (8 -0/+3 Days) STARTED	32 64	28 56
First Wear Period (8 -0/+3 Days) COMPLETED	32 64	26 52
First Wear Period (8 -0/+3 Days) NOT COMPLETED	0 0	2 4
Second Wear Period (8 -0/+3 Days) STARTED	32 64	26 52
Second Wear Period (8 -0/+3 Days) COMPLETED	32 62	26 52
Second Wear Period (8 -0/+3 Days) NOT COMPLETED	0 2	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Precision1, Then Infuse Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	Infuse, Then Precision1 Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
First Wear Period (8 -0/+3 Days) Adverse Event	0	1
First Wear Period (8 -0/+3 Days) Withdrawal by Subject	0	1

Baseline Characteristics

Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Precision1, Then Infuse n=32 Participants Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	Infuse, Then Precision1 n=28 Participants Kalifilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.	Total n=60 Participants Total of all reporting groups
Age, Continuous	34.9 years STANDARD_DEVIATION 8.2 • n=93 Participants	35.1 years STANDARD_DEVIATION 8.3 • n=4 Participants	35.0 years STANDARD_DEVIATION 8.2 • n=27 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	18 Participants n=4 Participants	39 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	10 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants	28 Participants n=4 Participants	56 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	27 Participants n=93 Participants	23 Participants n=4 Participants	50 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	32 participants n=93 Participants	28 participants n=4 Participants	60 participants n=27 Participants

PRIMARY outcome

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

Population: Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response