Trial Outcomes & Findings for Clinical Comparison of Two Daily Disposable Contact Lenses (NCT NCT04865354)

Last Updated: 2022-07-06

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

170 participants

Primary outcome timeframe

Day 8, each study lens type

Results posted on

2022-07-06

Participant Flow

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

Of the 170 enrolled, 3 subjects were exited prior to randomization as screen failures. This reporting group includes all randomized subjects (167).

Participant milestones

Participant milestones
Measure	PRECISION1, Then Clariti 1-Day Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Clariti 1-Day, Then PRECISION1 Somofilcon 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 days in a daily disposable modality.
First Wear Period (8 Days) STARTED	83	84
First Wear Period (8 Days) COMPLETED	82	83
First Wear Period (8 Days) NOT COMPLETED	1	1
Second Wear Period (8 Days) STARTED	82	83
Second Wear Period (8 Days) COMPLETED	81	83
Second Wear Period (8 Days) NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PRECISION1, Then Clariti 1-Day Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Clariti 1-Day, Then PRECISION1 Somofilcon 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 days in a daily disposable modality.
First Wear Period (8 Days) Withdrawal by Subject	1	0
First Wear Period (8 Days) Lost to Follow-up	0	1
Second Wear Period (8 Days) Protocol deviation, dispensed wrong powers	1	0

Baseline Characteristics

Clinical Comparison of Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRECISION1, Then Clariti 1-Day n=83 Participants Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Clariti 1-Day, Then PRECISION1 n=84 Participants Somofilcon 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 days in a daily disposable modality.	Total n=167 Participants Total of all reporting groups
Age, Continuous	31.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	31.4 years STANDARD_DEVIATION 7.5 • n=7 Participants	31.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	62 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=5 Participants	76 Participants n=7 Participants	154 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	69 Participants n=5 Participants	67 Participants n=7 Participants	136 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants	84 participants n=7 Participants	167 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8, each study lens type

Population: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study with non-missing response (eye)