Trial Outcomes & Findings for Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1 (NCT NCT04527978)

Last Updated: 2021-11-23

Results Overview

Distance 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 formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

Results posted on

2021-11-23

Participant Flow

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

Of the 56 subjects enrolled in the study, 1 subject was discontinued after randomization and prior to exposure to the study lenses. This reporting group includes all randomized and exposed subjects (55).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	PRECISION1, Then Biotrue ONEday Verofilcon A contact lenses worn first, with nesofilcon 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.	Biotrue ONEday, Then PRECISION1 Nesofilcon 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	27 54	28 56
First Wear Period (8 -0/+3 Days) COMPLETED	26 52	28 56
First Wear Period (8 -0/+3 Days) NOT COMPLETED	1 2	0 0
Second Wear Period (8 -0/+3 Days) STARTED	26 52	28 56
Second Wear Period (8 -0/+3 Days) COMPLETED	26 52	28 56
Second Wear Period (8 -0/+3 Days) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	PRECISION1, Then Biotrue ONEday Verofilcon A contact lenses worn first, with nesofilcon 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.	Biotrue ONEday, Then PRECISION1 Nesofilcon 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	1	0

Baseline Characteristics

Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRECISION1, Then Biotrue ONEday n=27 Participants Verofilcon A contact lenses worn first, with nesofilcon 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.	Biotrue ONEday, Then PRECISION1 n=28 Participants Nesofilcon 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=55 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 6.3 • n=99 Participants	34.3 years STANDARD_DEVIATION 8.9 • n=107 Participants	34.0 years STANDARD_DEVIATION 7.7 • n=206 Participants
Sex: Female, Male Female	20 Participants n=99 Participants	25 Participants n=107 Participants	45 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=99 Participants	27 Participants n=107 Participants	51 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	25 Participants n=99 Participants	26 Participants n=107 Participants	51 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	27 participants n=99 Participants	28 participants n=107 Participants	55 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

Population: Safety Analysis Set with non-missing response