Trial Outcomes & Findings for Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses (NCT NCT04555031)

Last Updated: 2021-11-08

Results Overview

Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

5 minutes

Results posted on

2021-11-08

Participant Flow

There were 10 participants. Each of the 10 participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion.

Participant milestones

Participant milestones
Measure	All Participants Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study, therefore each participant wore kalifilcon A lens, Dailies Total 1, Precision 1, and Biotrue ONEday. The only way to show demography for each lens is to show the same information for 10 participants that completed kalifilcon A lens wear, the 10 participants that completed Dailies Total 1 wear, the 10 participants that completed Precision 1 wear, and the 10 participants that completed Biotrue ONEday wear, but there are 10 participants total, not the 40 that the demography table would show if the duplicate information is entered for each lens to which a participant was exposed.
Age, Continuous	42.2 years STANDARD_DEVIATION 13.38 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes

Population: Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.

Outcome measures

Outcome measures
Measure	Kalifilcon A Lenses n=10 Participants kalifilcon A lenses: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Dailies Total 1 n=10 Participants Dalies Total 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Precision 1 n=10 Participants Precision 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Biotrue ONEday n=10 Participants Biotrue ONEday: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Surface Refractive Index Shifts at 5 Minutes	1.4102 No units Standard Deviation 0.00220	1.4251 No units Standard Deviation 0.00274	1.4188 No units Standard Deviation 0.00380	1.3788 No units Standard Deviation 0.00157

PRIMARY outcome

Timeframe: 10 minutes

Outcome measures

Outcome measures
Measure	Kalifilcon A Lenses n=10 Participants kalifilcon A lenses: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Dailies Total 1 n=10 Participants Dalies Total 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Precision 1 n=10 Participants Precision 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Biotrue ONEday n=10 Participants Biotrue ONEday: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Surface Refractive Index Shifts at 10 Minutes	1.4102 No units Standard Deviation 0.00241	1.4267 No units Standard Deviation 0.00113	1.4182 No units Standard Deviation 0.00286	1.3786 No units Standard Deviation 0.00080

PRIMARY outcome

Timeframe: 15 minutes

Outcome measures

Outcome measures
Measure	Kalifilcon A Lenses n=10 Participants kalifilcon A lenses: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Dailies Total 1 n=10 Participants Dalies Total 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Precision 1 n=10 Participants Precision 1: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.	Biotrue ONEday n=10 Participants Biotrue ONEday: Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Surface Refractive Index Shifts at 15 Minutes	1.4105 No units Standard Deviation 0.00163	1.4238 No units Standard Deviation 0.00213	1.4188 No units Standard Deviation 0.00306	1.3793 No units Standard Deviation 0.00150

Adverse Events

All Participants

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

Study Director

Bausch & Lomb

Phone: 5853386399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place