Trial Outcomes & Findings for Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses (NCT NCT05129072)

Results Overview

Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

60 minutes

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Kalifilcon A Daily Disposable Toric LD213001 Lens kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens
Overall Study STARTED	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kalifilcon A Daily Disposable Toric LD213001 Lens n=75 Participants kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens
Age, Categorical <=18 years	0 Participants n=75 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=75 Participants
Age, Categorical >=65 years	0 Participants n=75 Participants
Age, Continuous	49.2 Years STANDARD_DEVIATION 11.27 • n=75 Participants
Sex: Female, Male Female	32 Participants n=75 Participants
Sex: Female, Male Male	43 Participants n=75 Participants
Region of Enrollment United States	75 participants n=75 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: 30 eyes wore the +3D, 0D, -3D, -6D, and -9D contact lenses. 26 eyes wore the +6D contact lenses.

Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis.

Outcome measures

Outcome measures
Measure	Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens n=56 Lenses kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens
Spherical Aberration Measurement T01 (kali +6D)	0.162 microns Standard Deviation 0.187
Spherical Aberration Measurement T02 (kali +3D)	0.090 microns Standard Deviation 0.120
Spherical Aberration Measurement T03 (kali 0D)	0.017 microns Standard Deviation 0.133
Spherical Aberration Measurement T04 (kali -3D)	0.052 microns Standard Deviation 0.145
Spherical Aberration Measurement T05 (kali -6D)	0.062 microns Standard Deviation 0.158
Spherical Aberration Measurement T06 (kali -9D)	0.102 microns Standard Deviation 0.164

SECONDARY outcome

Timeframe: 60 minutes

Population: 30 eyes wore the +3D, 0D, -3D, -6D, and -9D contact lenses. 26 eyes wore the +6D contact lenses.

Number of lenses the investigator could identify the toric etch mark

Outcome measures

Outcome measures
Measure	Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens n=56 Lenses kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens
Visibility of Toric Etch Mark by the Investigator T01 kali +6D	26 Lenses
Visibility of Toric Etch Mark by the Investigator T06 kali -9D	30 Lenses
Visibility of Toric Etch Mark by the Investigator T02 kali +3D	30 Lenses
Visibility of Toric Etch Mark by the Investigator T03 kali +0D	30 Lenses
Visibility of Toric Etch Mark by the Investigator T04 kali -3D	30 Lenses
Visibility of Toric Etch Mark by the Investigator T05 kali -6D	30 Lenses

Adverse Events

Kalifilcon A Daily Disposable Toric LD213001 Lens

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

Steffen Robert, Senior Director Clinical Affairs

Bausch + Lomb Incorporated

Phone: 15853386399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place