Trial Outcomes & Findings for Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses (NCT NCT05129124)

Last Updated: 2025-07-10

Results Overview

Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

3 minutes

Results posted on

2025-07-10

Participant Flow

There are a total of 14 study lens types (8 test contact lenses and 6 comparators contact lenses). Each study lens type will be worn once for approximately 10 minutes.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	All Participants Received Kalifilcon LD213001 Contact Lenses & Ultra for Astigmatism Contact Lenses Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses). Each study lens type will be worn once for approximately 10 minutes.
Overall Study STARTED	30 60
Overall Study Experimental: T01: +6.00 -2.75 x 180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T02: +6.00-2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T03: -3.00-2.75 x180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T04: -3.00 -2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T05: -9.00 -2.75 x 180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T06: -9.00 -2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T07: -12.00 -2.75 x 180 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study Experimental: T08: -12.00-2.75 x 090 Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses	30 60
Overall Study C01: +6.00 -2.75 x 180 Commercially Available Ultra for Astigmatism Contact Lenses	30 60
Overall Study C02: +6.00-2.75 x 090 Commercially Available Ultra for Astigmatism Contact Lenses	30 60
Overall Study C03: -3.00-2.75 x180 Commercially Available Ultra for Astigmatism Contact Lenses	30 60
Overall Study C04: -3.00 -2.75 x 090 Commercially Available Ultra for Astigmatism Contact Lenses	30 60
Overall Study C05: -9.00 -2.75 x 180 Commercially Available Ultra for Astigmatism Contact Lenses	30 60
Overall Study C06: -9.00 -2.75 x 090 Commercially Available Ultra for Astigmatism Contact Lenses	30 60
Overall Study COMPLETED	30 60
Overall Study NOT COMPLETED	0 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	All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses n=30 Participants Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses). Each study lens type will be worn once for approximately 10 minutes.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	43.8 Years STANDARD_DEVIATION 13.22 • n=30 Participants
Sex: Female, Male Female	17 Participants n=30 Participants
Sex: Female, Male Male	13 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 3 minutes

Population: Measurement Description: Lens orientation (in 5-degree increments) was measured in primary gaze (nasal = +, temporal = -)

Outcome measures

Outcome measures
Measure	All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses n=60 Eyes Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses). Each study lens type will be worn once for approximately 10 minutes.
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T01	1.3 degrees Standard Deviation 3.92
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees C01	3.3 degrees Standard Deviation 7.47
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T02	2.0 degrees Standard Deviation 4.47
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees C02	3.0 degrees Standard Deviation 9.43
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T03	1.7 degrees Standard Deviation 3.79
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees C03	4.0 degrees Standard Deviation 16.42
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T04	4.2 degrees Standard Deviation 13.90
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees C04	1.3 degrees Standard Deviation 2.60
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T05	3.3 degrees Standard Deviation 9.32
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees C05	5.3 degrees Standard Deviation 9.37
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T06	2.8 degrees Standard Deviation 12.78
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees C06	5.0 degrees Standard Deviation 16.56
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T07	5.7 degrees Standard Deviation 11.58
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees T08	3.5 degrees Standard Deviation 7.09

Adverse Events

All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses

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

Jill Schafer

Bausch + Lomb Incorporated

Phone: 0000000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place