Trial Outcomes & Findings for Kalifilcon A Toric Compared to Commercially Available Lenses (NCT NCT06098937)
NCT ID: NCT06098937
Last Updated: 2024-12-10
Results Overview
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
5 minutes after lens insertion
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Kalifilcon A Daily Disposable Toric Compared to Total1, Precision1, and MyDay Toric.
Participants received kalifilcon A daily disposable toric, commercially available Total1 for Astigmatism, Precision1 for Astigmatism, and MyDay Toric.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Kalifilcon A Daily Disposable Toric
|
30
|
|
Overall Study
Total1 for Astigmatism
|
30
|
|
Overall Study
Precision1 for Astigmatism
|
30
|
|
Overall Study
MyDay Toric Lenses
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Kalifilcon A Toric Compared to Commercially Available Lenses
Baseline characteristics by cohort
| Measure |
Kalifilcon A Daily Disposable Toric, Total1, Precision1, and MyDay Toric.
n=30 Participants
Participants received kalifilcon A daily disposable toric, Total1 for Astigmatism, Precision1 for Astigmatism, and MyDay Toric.
|
|---|---|
|
Age, Continuous
Age 28 to 70
|
46.6 years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after lens insertionPrimary gaze orientation is measured in degrees using a slit lamp and reticule.
Outcome measures
| Measure |
Kalifilcon A Daily Disposable Toric
n=30 Participants
Participants received kalifilcon A daily disposable toric
|
Total1 for Astigmatism
n=30 Participants
Participants received commercially available Total1 for Astigmatism
|
Precision1 for Astigmatism
n=30 Participants
Participants received Precision1 for Astigmatism
|
MyDay Toric
n=30 Participants
Participants received MyDay Toric
|
|---|---|---|---|---|
|
Primary Gaze Orientation for 5 Minutes
|
3.3 degrees
Standard Deviation 5.19
|
2.8 degrees
Standard Deviation 4.16
|
2.4 degrees
Standard Deviation 3.96
|
3.6 degrees
Standard Deviation 5.45
|
Adverse Events
Kalifilcon A Daily Disposable Toric, Total1, Precision1, and MyDay Toric.
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, OD, MS Director, Clinical Research
Bausch & Lomb
Phone: 585-338-5664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place