Trial Outcomes & Findings for Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear (NCT NCT03614130)

Last Updated: 2021-09-30

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

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

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

Results posted on

2021-09-30

Participant Flow

Subjects were recruited from 2 investigative sites located in the United States.

This reporting group includes all enrolled subjects.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID011121 (OD) / Biofinity (OS) LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear	Biofinity (OD) / LID011121 (OS) Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Overall Study STARTED	10 20	12 24
Overall Study COMPLETED	10 20	12 24
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID011121 (OD) / Biofinity (OS) n=10 Participants LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear	Biofinity (OD) / LID011121 (OS) n=12 Participants Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear	Total n=22 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 7.7 • n=5 Participants	38.3 years STANDARD_DEVIATION 10.3 • n=7 Participants	40.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

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

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	LID011121 n=22 Participants LID011121 contact lens worn in the right eye or left eye, as randomized, for approximately 6 nights of extended (overnight) wear	Biofinity n=22 Participants Comfilcon A contact lens worn in the right eye or left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Visual Acuity (VA) With Study Lenses, Collected by Eye Day 1 Dispense	-0.04 logMAR Standard Deviation 0.06	-0.06 logMAR Standard Deviation 0.06
Visual Acuity (VA) With Study Lenses, Collected by Eye Day 2 Follow-up	-0.06 logMAR Standard Deviation 0.11	-0.09 logMAR Standard Deviation 0.06
Visual Acuity (VA) With Study Lenses, Collected by Eye Week 1 Follow-up/Exit	-0.06 logMAR Standard Deviation 0.07	-0.08 logMAR Standard Deviation 0.06

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LID011121 - 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