Trial Outcomes & Findings for Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens (NCT NCT04422990)

Last Updated: 2022-03-29

Results Overview

Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

Week 1 Follow-Up

Results posted on

2022-03-29

Participant Flow

Participants were recruited from 14 sites located in the United States.

Of the 158 enrolled, 11 subjects were not dispensed study lenses and were exited from the study as screen failures. This reporting group includes all subjects who were dispensed study lenses (147).

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Biofinity Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	LID018869 Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
Overall Study STARTED	50 100	97 194
Overall Study COMPLETED	47 94	96 192
Overall Study NOT COMPLETED	3 6	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Biofinity Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	LID018869 Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
Overall Study Withdrawal by Subject	0	1
Overall Study Travel	3	0

Baseline Characteristics

Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofinity n=49 Participants Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	LID018869 n=92 Participants Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Total n=141 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 9.7 • n=99 Participants	33.1 years STANDARD_DEVIATION 10.8 • n=107 Participants	33.2 years STANDARD_DEVIATION 10.4 • n=206 Participants
Sex: Female, Male Female	36 Participants n=99 Participants	61 Participants n=107 Participants	97 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	31 Participants n=107 Participants	44 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=99 Participants	87 Participants n=107 Participants	136 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/Ethnicity, Customized White	12 Participants n=99 Participants	20 Participants n=107 Participants	32 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Chinese	31 Participants n=99 Participants	61 Participants n=107 Participants	92 Participants n=206 Participants
Race/Ethnicity, Customized Japanese	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Race/Ethnicity, Customized Korean	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Race/Ethnicity, Customized Other Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: Week 1 Follow-Up

Population: PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group.

Outcome measures

Outcome measures
Measure	Biofinity n=176 eyes Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	LID018869 n=340 eyes Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up	-0.06 logMAR Standard Error 0.00	-0.06 logMAR Standard Error 0.00

SECONDARY outcome

Timeframe: Week 1 Follow-Up

Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.