Trial Outcomes & Findings for Product Performance of a New Silicone Hydrogel Contact Lens (NCT NCT04901897)

NCT ID: NCT04901897

Last Updated: 2021-07-08

Results Overview

logMAR is the logarithm of the minim angle of resolution

Recruitment status

COMPLETED

Study phase

Target enrollment

805 participants

Primary outcome timeframe

Baseline, 2 Week Follow up

Results posted on

2021-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Kalifilcon A kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	Delefilcon A DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Senofilcon A Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Overall Study STARTED	398	202	205
Overall Study COMPLETED	393	200	203
Overall Study NOT COMPLETED	5	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Product Performance of a New Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kalifilcon A n=398 Participants kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	Delefilcon A n=202 Participants DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Senofilcon A n=205 Participants Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens	Total n=805 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	10 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	20 Participants n=483 Participants
Age, Continuous	30.5 years STANDARD_DEVIATION 5.72 • n=93 Participants	30.0 years STANDARD_DEVIATION 6.11 • n=4 Participants	29.3 years STANDARD_DEVIATION 5.78 • n=27 Participants	30.3 years STANDARD_DEVIATION 5.95 • n=483 Participants
Sex: Female, Male Female	262 Participants n=93 Participants	125 Participants n=4 Participants	140 Participants n=27 Participants	527 Participants n=483 Participants
Sex: Female, Male Male	136 Participants n=93 Participants	77 Participants n=4 Participants	65 Participants n=27 Participants	278 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Asian	56 Participants n=93 Participants	30 Participants n=4 Participants	26 Participants n=27 Participants	112 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	8 Participants n=483 Participants
Race (NIH/OMB) Black or African American	47 Participants n=93 Participants	17 Participants n=4 Participants	25 Participants n=27 Participants	89 Participants n=483 Participants
Race (NIH/OMB) White	281 Participants n=93 Participants	147 Participants n=4 Participants	146 Participants n=27 Participants	574 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline, 2 Week Follow up

logMAR is the logarithm of the minim angle of resolution

Outcome measures

Outcome measures
Measure	Kalifilcon A n=796 eyes kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	Delefilcon A n=404 eyes DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Senofilcon A n=410 eyes Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Mean Change in logMAR Contact Lens Visual Acuity	-0.056 logMAR Standard Deviation 0.0727	-0.069 logMAR Standard Deviation 0.0733	-0.069 logMAR Standard Deviation 0.0718

PRIMARY outcome

Timeframe: 2 Week Follow up

Population: Participants with 2 week follow up and responded to the question.

Outcome measures

Outcome measures
Measure	Kalifilcon A n=391 Participants kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	Delefilcon A n=200 Participants DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Senofilcon A n=199 Participants Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"	317 Participants	160 Participants	166 Participants

PRIMARY outcome

Timeframe: 2 Week Follow up

Population: Participants with 2 week follow up and responded to the question.

Outcome measures

Outcome measures
Measure	Kalifilcon A n=392 Participants kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	Delefilcon A n=201 Participants DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Senofilcon A n=201 Participants Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"	358 Participants	184 Participants	188 Participants

Adverse Events

Kalifilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A

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

Daniel Donatello

Bausch & Lomb

Phone: 5853385306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER