Trial Outcomes & Findings for Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses (NCT NCT05050578)

Last Updated: 2023-03-16

Results Overview

Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Recruitment status

COMPLETED

Study phase

Target enrollment

166 participants

Primary outcome timeframe

Day 30, each study lens type

Results posted on

2023-03-16

Participant Flow

Subjects were recruited from 10 investigative sites located in the United States.

Of the 166 enrolled, 3 subjects were exited from the study prior to randomization as screen failures, and 1 randomized subject was discontinued prior to exposure to the study lenses. This reporting group includes all subjects exposed to the study lenses, as treated (162).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID018869, Then AOHP Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	AOHP, Then LID018869 Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.
Period 1, 30 Days STARTED	82 164	80 160
Period 1, 30 Days COMPLETED	80 160	79 158
Period 1, 30 Days NOT COMPLETED	2 4	1 2
Period 2, 30 Days STARTED	80 160	79 158
Period 2, 30 Days COMPLETED	80 160	78 156
Period 2, 30 Days NOT COMPLETED	0 0	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	LID018869, Then AOHP Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	AOHP, Then LID018869 Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.
Period 1, 30 Days Lost to Follow-up	1	1
Period 1, 30 Days Withdrawal by Subject	1	0
Period 2, 30 Days Protocol Violation	0	1

Baseline Characteristics

Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID018869, Then AOHP n=82 Participants Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	AOHP, Then LID018869 n=80 Participants Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection.	Total n=162 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 8.2 • n=5 Participants	33.1 years STANDARD_DEVIATION 8.5 • n=7 Participants	32.8 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	49 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants	69 Participants n=7 Participants	139 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	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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	20 Participants n=5 Participants	18 Participants n=7 Participants	38 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30, each study lens type

Population: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this clinical study with data at Day 30.