Trial Outcomes & Findings for Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses (NCT NCT06165627)

Last Updated: 2025-05-29

Results Overview

Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.

Results posted on

2025-05-29

Participant Flow

Of the 67 enrolled, 1 participant was discontinued following randomization but prior to exposure to the study lenses. This reporting group includes all participants exposed to any study lenses evaluated in this study (66).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	T30fA, Then Biofinity Toric Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.	Biofinity Toric, Then T30fA Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.
First Wear Period (Approx. 30 Days) STARTED	34 68	32 64
First Wear Period (Approx. 30 Days) COMPLETED	34 68	32 64
First Wear Period (Approx. 30 Days) NOT COMPLETED	0 0	0 0
Second Wear Period (Approx. 30 Days) STARTED	34 68	32 64
Second Wear Period (Approx. 30 Days) COMPLETED	34 68	32 64
Second Wear Period (Approx. 30 Days) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T30fA, Then Biofinity Toric n=34 Participants Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.	Biofinity Toric, Then T30fA n=32 Participants Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.	Total n=66 Participants Total of all reporting groups
Age, Continuous	32.6 years STANDARD_DEVIATION 7.9 • n=5 Participants	31.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	32.3 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	27 Participants n=7 Participants	57 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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 American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	17 Participants n=5 Participants	17 Participants n=7 Participants	34 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 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	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.

Population: Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response. Note, One subject in the Biofinity Toric arm lost a lens on the way to the visit. Hence, the assessment was taken on 1 eye only.