Trial Outcomes & Findings for Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear (NCT NCT04403542)

Last Updated: 2023-08-22

Results Overview

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 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit

Results posted on

2023-08-22

Participant Flow

Subjects were recruited from 3 investigative sites located in the United States.

This reporting group includes all enrolled subjects.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID018869 (OD) / Biofinity (OS) Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear	Biofinity (OD) / LID018869 (OS) Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Overall Study STARTED	18 36	18 36
Overall Study COMPLETED	18 36	18 36
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID018869 (OD) / Biofinity (OS) n=18 Participants Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear	Biofinity (OD) / LID018869 (OS) n=18 Participants Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear	Total n=36 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 7.9 • n=5 Participants	33.9 years STANDARD_DEVIATION 10.5 • n=7 Participants	33.2 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	16 Participants n=7 Participants	34 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	LID018869 n=36 eyes Lehfilcon A contact lens worn in the right eye or left eye, as randomized, for approximately 1 week of continuous wear	Biofinity n=36 eyes Comfilcon A contact lens worn in the right eye or left eye, as randomized, for approximately 1 week of continuous wear
Distance Visual Acuity (VA) With Study Lenses Day 1 Dispense	-0.03 logMAR Standard Deviation 0.05	-0.04 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses Day 2 Follow-up	-0.03 logMAR Standard Deviation 0.05	-0.03 logMAR Standard Deviation 0.05
Distance Visual Acuity (VA) With Study Lenses Week 1 Follow-up/Exit	-0.03 logMAR Standard Deviation 0.05	-0.03 logMAR Standard Deviation 0.05

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LID018869 Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biofinity Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nonocular/Systemic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CDMA Project Lead, Vision Care

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER