Trial Outcomes & Findings for Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses (NCT NCT05056987)

Last Updated: 2023-06-18

Results Overview

Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. 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 lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)

Results posted on

2023-06-18

Participant Flow

Participants were recruited from one investigative site located in the United Kingdom.

This reporting group includes all enrolled subjects/eyes.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	TOTAL30, Then AOHP Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses were worn for approximately 28 days. The senofilcon A contact lenses were worn for approximately 14 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.	AOHP, Then TOTAL30 Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses were worn for approximately 14 days. The lehfilcon A contact lenses were worn for approximately 28 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
First Wear Period, Day 14 or Day 28 STARTED	18 36	18 36
First Wear Period, Day 14 or Day 28 COMPLETED	17 34	16 32
First Wear Period, Day 14 or Day 28 NOT COMPLETED	1 2	2 4
Second Wear Period, Day 14 or Day 28 STARTED	17 34	16 32
Second Wear Period, Day 14 or Day 28 COMPLETED	17 34	16 32
Second Wear Period, Day 14 or Day 28 NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	TOTAL30, Then AOHP Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses were worn for approximately 28 days. The senofilcon A contact lenses were worn for approximately 14 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.	AOHP, Then TOTAL30 Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses were worn for approximately 14 days. The lehfilcon A contact lenses were worn for approximately 28 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.
First Wear Period, Day 14 or Day 28 Adverse Event	1	0
First Wear Period, Day 14 or Day 28 Withdrawal by Subject	0	2

Baseline Characteristics

Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TOTAL30, Then AOHP n=18 Participants Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses were worn for approximately 28 days. The senofilcon A contact lenses were worn for approximately 14 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.	AOHP, Then TOTAL30 n=18 Participants Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses were worn for approximately 14 days. The lehfilcon A contact lenses were worn for approximately 28 days. Lenses were worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.	Total n=36 Participants Total of all reporting groups
Age, Continuous	28.8 years STANDARD_DEVIATION 11.3 • n=93 Participants	32.9 years STANDARD_DEVIATION 10.6 • n=4 Participants	30.9 years STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	15 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)

Population: Safety analysis set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing responses.