Trial Outcomes & Findings for Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses (NCT NCT05483127)

Last Updated: 2023-11-02

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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

153 participants

Primary outcome timeframe

Day 8 of each study lens type worn during the corresponding crossover period

Results posted on

2023-11-02

Participant Flow

Participants were recruited from 11 investigative sites located in the United States.

Of the 153 enrolled, 1 participant was exited prior to randomization as a screen failure. This reporting group includes all randomized participants (152).

Participant milestones

Participant milestones
Measure	P1fA, Then MDT Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use.	MDT, Then P1fA Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use.
First Wear Period, 8 (-0/+3) Days STARTED	77	75
First Wear Period, 8 (-0/+3) Days COMPLETED	77	75
First Wear Period, 8 (-0/+3) Days NOT COMPLETED	0	0
Second Wear Period, 8 (-0/+3) Days STARTED	76	75
Second Wear Period, 8 (-0/+3) Days COMPLETED	76	75
Second Wear Period, 8 (-0/+3) Days NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	P1fA, Then MDT n=77 Participants Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use.	MDT, Then P1fA n=75 Participants Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use.	Total n=152 Participants Total of all reporting groups
Age, Continuous	34.6 years STANDARD_DEVIATION 9.4 • n=93 Participants	34.3 years STANDARD_DEVIATION 8.6 • n=4 Participants	34.4 years STANDARD_DEVIATION 9.0 • n=27 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	46 Participants n=4 Participants	94 Participants n=27 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	29 Participants n=4 Participants	58 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=93 Participants	66 Participants n=4 Participants	131 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/Ethnicity, Customized White	66 Participants n=93 Participants	66 Participants n=4 Participants	132 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Multi-Racial	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	77 participants n=93 Participants	75 participants n=4 Participants	152 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 8 of each study lens type worn during the corresponding crossover period

Population: Full Analysis Set with data at visit.