Trial Outcomes & Findings for Clinical Performance of Two Commercial, Daily Disposable Contact Lenses (NCT NCT05010512)

Last Updated: 2022-11-08

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

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

Results posted on

2022-11-08

Participant Flow

This study was conducted at 8 investigative sites in the United States.

Of the 112 enrolled, one subject was exited prior to randomization as a screen failure. This reporting group includes all randomized subjects (111).

Participant milestones

Participant milestones
Measure	DT1, Then Infuse Delefilcon 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 on a daily wear, daily disposable basis.	Infuse, Then DT1 Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
Period 1, 8 (-0/+3) Days STARTED	55	56
Period 1, 8 (-0/+3) Days COMPLETED	55	56
Period 1, 8 (-0/+3) Days NOT COMPLETED	0	0
Period 2, 8 (-0/+3) Days STARTED	55	56
Period 2, 8 (-0/+3) Days COMPLETED	55	56
Period 2, 8 (-0/+3) Days NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DT1, Then Infuse n=55 Participants Delefilcon 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 on a daily wear, daily disposable basis.	Infuse, Then DT1 n=56 Participants Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.	Total n=111 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 8.2 • n=5 Participants	32.4 years STANDARD_DEVIATION 7.4 • n=7 Participants	33.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	53 Participants n=7 Participants	102 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/Ethnicity, Customized White	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	56 participants n=7 Participants	111 participants n=5 Participants

PRIMARY outcome

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

Population: FAS with non-missing response (eye)