Trial Outcomes & Findings for Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 Lenses (NCT NCT04840563)

Last Updated: 2026-08-05

Results Overview

Immediately following lens removal, the right-eye worn lens for each participant was measured for surface refractive index on a Metricon M-2010 Prism Coupler. A new lens pair was worn for each wear time. Surface refractive index is a dimensionless ratio and has no units.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Unworn lens (baseline) and immediately after 0.5, 1, 3, 5, and 10 minutes of lens wear

Results posted on

2026-08-05

Participant Flow

10 participants were screened for eligibility on April 7, 2021 at the Bausch + Lomb Incorporated Research Clinic, Rochester, New York, United States.

All 10 screened participants met all eligibility criteria and none of the exclusion criteria, and all 10 were assigned to study lens wear. There were no pre-assignment exclusions or withdrawals.

Participant milestones

Participant milestones
Measure	All Participants: Kalifilcon A, Then Dailies Total1, Then Precision1 Participants wore all three study lens types bilaterally, one lens type per pair of visits, in the single order specified by the study randomization schedule: kalifilcon A first, then Dailies Total1 (delefilcon A), then Precision1 (verofilcon A). For each lens type, a new lens pair was inserted for each wear time of 0.5, 1, 3, 5 and 10 minutes, with a 3-5 minute washout period between lens pairs. Wear times of 0.5, 1 and 3 minutes were completed at one visit and 5 and 10 minutes at the next visit, giving 2 visits per lens type and 6 visits in total. All lenses were -3.00 D.
1st: kalifilcon A (0.5-10 min) STARTED	10
1st: kalifilcon A (0.5-10 min) COMPLETED	10
1st: kalifilcon A (0.5-10 min) NOT COMPLETED	0
2nd: Dailies Total1 (0.5-10 min) STARTED	10
2nd: Dailies Total1 (0.5-10 min) COMPLETED	10
2nd: Dailies Total1 (0.5-10 min) NOT COMPLETED	0
3rd: Precision1 (0.5-10 min) STARTED	10
3rd: Precision1 (0.5-10 min) COMPLETED	10
3rd: Precision1 (0.5-10 min) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants: Kalifilcon A, Then Dailies Total1, Then Precision1 n=10 Participants All 10 enrolled participants. Each participant wore kalifilcon A, Dailies Total1 (delefilcon A) and Precision1 (verofilcon A) lenses bilaterally in the order specified by the study randomization schedule. The randomization schedule was produced prior to the start of the study. The lens order (randomization order) was the same for all participants.
Age, Continuous	34.9 years STANDARD_DEVIATION 11.95 • n=20 Participants
Sex: Female, Male Female	7 Participants n=20 Participants
Sex: Female, Male Male	3 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants
Race (NIH/OMB) White	10 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	10 Participants n=20 Participants

PRIMARY outcome

Timeframe: Unworn lens (baseline) and immediately after 0.5, 1, 3, 5, and 10 minutes of lens wear

Population: All 10 enrolled participants. For each lens type and wear time, the right-eye worn lens of each participant was measured (n = 10 lenses per lens type per wear time). Unworn (baseline) values are the mean of 10 unworn lenses of each type, measured under study ROC2-20-012.

Outcome measures

Outcome measures
Measure	Kalifilcon A Lenses n=10 Participants Commercially available kalifilcon A daily disposable spherical soft contact lens (Bausch + Lomb), -3.00 D.	Dailies Total1 n=10 Participants Commercially available Dailies Total1 (delefilcon A) daily disposable spherical soft contact lens (Alcon), -3.00 D.	Precision1 n=10 Participants Commercially available Precision1 (verofilcon A) daily disposable spherical soft contact lens (Alcon), -3.00 D.
Surface Refractive Index of Worn Lenses Unworn lens	1.4038 refractive index (dimensionless ratio) Standard Deviation 0.0002	1.3382 refractive index (dimensionless ratio) Standard Deviation 0.0001	1.3380 refractive index (dimensionless ratio) Standard Deviation 0.0002
Surface Refractive Index of Worn Lenses 0.5 minutes	1.4086 refractive index (dimensionless ratio) Standard Deviation 0.0027	1.4231 refractive index (dimensionless ratio) Standard Deviation 0.0030	1.4147 refractive index (dimensionless ratio) Standard Deviation 0.0018
Surface Refractive Index of Worn Lenses 1 minute	1.4084 refractive index (dimensionless ratio) Standard Deviation 0.0025	1.4243 refractive index (dimensionless ratio) Standard Deviation 0.0013	1.4165 refractive index (dimensionless ratio) Standard Deviation 0.0028
Surface Refractive Index of Worn Lenses 3 minutes	1.4093 refractive index (dimensionless ratio) Standard Deviation 0.0017	1.4255 refractive index (dimensionless ratio) Standard Deviation 0.0027	1.4178 refractive index (dimensionless ratio) Standard Deviation 0.0042
Surface Refractive Index of Worn Lenses 5 minutes	1.4100 refractive index (dimensionless ratio) Standard Deviation 0.0021	1.4257 refractive index (dimensionless ratio) Standard Deviation 0.0022	1.4207 refractive index (dimensionless ratio) Standard Deviation 0.0051
Surface Refractive Index of Worn Lenses 10 minutes	1.4110 refractive index (dimensionless ratio) Standard Deviation 0.0028	1.4264 refractive index (dimensionless ratio) Standard Deviation 0.0029	1.4182 refractive index (dimensionless ratio) Standard Deviation 0.0034

Adverse Events

Kalifilcon A Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dailies Total1 (Delefilcon A) Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Precision1 (Verofilcon A) 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

Jeffery Schafer, Director Clinical Research

Bausch & Lomb Incorporated

Phone: 585-754-4680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place