Trial Outcomes & Findings for Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens (NCT NCT04207749)

NCT ID: NCT04207749

Last Updated: 2022-02-02

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

249 participants

Primary outcome timeframe

Week 1 Follow-Up

Results posted on

2022-02-02

Participant Flow

This study was conducted at 18 investigative sites located in the United States.

Of the 249 participants enrolled in this study, 15 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects/eyes (234/468).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Biofinity Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
Overall Study STARTED	78 156	156 312
Overall Study COMPLETED	74 148	149 298
Overall Study NOT COMPLETED	4 8	7 14

Reasons for withdrawal

Reasons for withdrawal
Measure	Biofinity Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
Overall Study Lost to Follow-up	0	2
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	3	0
Overall Study Unable to attend study visits due to COVID-19 pandemic	1	4

Baseline Characteristics

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofinity n=75 Participants Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 n=145 Participants LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	Total n=220 Participants Total of all reporting groups
Age, Continuous	32.7 years STANDARD_DEVIATION 8.2 • n=5 Participants	31.3 years STANDARD_DEVIATION 9.1 • n=7 Participants	31.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	105 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	40 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants	139 Participants n=7 Participants	211 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	30 Participants n=5 Participants	65 Participants n=7 Participants	95 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	32 Participants n=5 Participants	64 Participants n=7 Participants	96 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Korean	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	145 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1 Follow-Up

Population: PP. A predefined subset of data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit.

Outcome measures

Outcome measures
Measure	Biofinity n=212 eyes Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 n=400 eyes LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)	-0.06 logMAR Standard Error 0.00	-0.05 logMAR Standard Error 0.00

SECONDARY outcome

Timeframe: Week 1 Follow-Up, at least 4 hours after lens insertion

Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.