Trial Outcomes & Findings for Orientation Characteristics of Daily Disposable Toric Contact Lenses (NCT NCT06069609)
NCT ID: NCT06069609
Last Updated: 2025-07-01
Results Overview
Primary gaze orientation 5 minutes after lens insertion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Assessed 5 minutes after lens insertion
Results posted on
2025-07-01
Participant Flow
30 Subjects were screened for eligibility between August 11, 2023 and August 15, 2023.
30 of 30 subjects were randomized.
Participant milestones
| Measure |
Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism
Participants first received kalifilcon A Daily Disposable Toric then received control lens on day of study visit.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Kalifilcon A Daily Disposable Toric
|
30
|
|
Overall Study
Acuvue Oasys 1-Day for Astigmatism
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Orientation Characteristics of Daily Disposable Toric Contact Lenses
Baseline characteristics by cohort
| Measure |
Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism
n=30 Participants
All 30 subjects that completed the study received both kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism
|
|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : More than one race
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed 5 minutes after lens insertionPrimary gaze orientation 5 minutes after lens insertion
Outcome measures
| Measure |
Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism
n=30 Participants
All 30 subjects that completed the study received both kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism
|
|---|---|
|
Primary Gaze Orientation
kalifilcon A toric lenses at 5 min
|
2.4 Degrees
Standard Deviation 3.62
|
|
Primary Gaze Orientation
Acuvue Oasys 1-Day for Astigmatism at 5 min
|
7.9 Degrees
Standard Deviation 13.54
|
Adverse Events
Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism
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