Trial Outcomes & Findings for 1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia (NCT NCT05325931)
NCT ID: NCT05325931
Last Updated: 2026-08-06
Results Overview
Mean Binocular logMAR Visual Acuity at Distance (6m)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
One week (follow-up visit)
Results posted on
2026-08-06
Participant Flow
30 patients were screened for eligibility between February 25, 2022 and March 15, 2022.
30 subjects were enrolled and randomized 1:1 to one of two treatment sequences. (No screen failures.)
Participant milestones
| Measure |
Kalifilcon A Daily Disposable Multifocal First, Then Samfilcon A for Presbyopia
Participants wore kalifilcon A Daily Disposable Multifocal (Test) lenses bilaterally on a daily-disposable (single-use, discarded after each removal) basis, at least 8 hours/day for approximately 1 week (First Intervention), then crossed over to Ultra for Presbyopia (samfilcon A, Comparator) lenses bilaterally on the same daily-disposable basis for approximately 1 week (Second Intervention). There was no washout period.
|
Samfilcon A for Presbyopia First, Then Kalifilcon A Daily Disposable Multifocal
Participants wore Ultra for Presbyopia (samfilcon A, Comparator) lenses bilaterally on a daily-disposable (single-use, discarded after each removal) basis, at least 8 hours/day for approximately 1 week (First Intervention), then crossed over to kalifilcon A Daily Disposable Multifocal (Test) lenses bilaterally on the same daily-disposable basis for approximately 1 week (Second Intervention). There was no washout period.
|
|---|---|---|
|
First Intervention (1 Week)
STARTED
|
15
|
15
|
|
First Intervention (1 Week)
COMPLETED
|
15
|
15
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
15
|
15
|
|
Second Intervention (1 Week)
COMPLETED
|
15
|
14
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Kalifilcon A Daily Disposable Multifocal First, Then Samfilcon A for Presbyopia
Participants wore kalifilcon A Daily Disposable Multifocal (Test) lenses bilaterally on a daily-disposable (single-use, discarded after each removal) basis, at least 8 hours/day for approximately 1 week (First Intervention), then crossed over to Ultra for Presbyopia (samfilcon A, Comparator) lenses bilaterally on the same daily-disposable basis for approximately 1 week (Second Intervention). There was no washout period.
|
Samfilcon A for Presbyopia First, Then Kalifilcon A Daily Disposable Multifocal
Participants wore Ultra for Presbyopia (samfilcon A, Comparator) lenses bilaterally on a daily-disposable (single-use, discarded after each removal) basis, at least 8 hours/day for approximately 1 week (First Intervention), then crossed over to kalifilcon A Daily Disposable Multifocal (Test) lenses bilaterally on the same daily-disposable basis for approximately 1 week (Second Intervention). There was no washout period.
|
|---|---|---|
|
Second Intervention (1 Week)
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total - All Participants, Combined Across Treatment Sequences
n=29 Participants
Total - All participants, combined across treatment sequences. Baseline characteristics are summarized for the 29 participants who completed both study lens types. One enrolled participant discontinued during the second period and is not included in the baseline summary.
|
|---|---|
|
Age, Continuous
|
53.9 Years
STANDARD_DEVIATION 5.5 • n=29 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: One week (follow-up visit)Population: The 29 participants who completed both study lens types and had 1-week follow-up visual acuity measured. One enrolled participant discontinued during the second period (missed final visit) and had no second-period data.
Mean Binocular logMAR Visual Acuity at Distance (6m)
Outcome measures
| Measure |
Kalifilcon A Daily Disposable Multifocal (Test)
n=29 Participants
Participants during the period they wore the Test lens (kalifilcon A daily disposable multifocal), regardless of sequence.
|
Ultra (Samfilcon A) for Presbyopia (Comparator)
n=29 Participants
Participants during the period they wore the Comparator lens (Ultra for Presbyopia, samfilcon A), regardless of sequence.
|
|---|---|---|
|
Visual Acuity (Distance)
|
-0.091 logMAR
Standard Deviation 0.0788
|
-0.074 logMAR
Standard Deviation 0.0691
|
PRIMARY outcome
Timeframe: One week (follow-up)Population: The 29 participants who completed both study lens types and had 1-week follow-up visual acuity measured. One enrolled participant discontinued during the second period (missed final visit) and had no second-period data.
Mean Binocular logMAR Visual Acuity at Near (40cm)
Outcome measures
| Measure |
Kalifilcon A Daily Disposable Multifocal (Test)
n=29 Participants
Participants during the period they wore the Test lens (kalifilcon A daily disposable multifocal), regardless of sequence.
|
Ultra (Samfilcon A) for Presbyopia (Comparator)
n=29 Participants
Participants during the period they wore the Comparator lens (Ultra for Presbyopia, samfilcon A), regardless of sequence.
|
|---|---|---|
|
Visual Acuity (Near)
|
0.179 logMAR
Standard Deviation 0.1679
|
0.182 logMAR
Standard Deviation 0.1771
|
Adverse Events
Kalifilcon A Multifocal (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultra (Samfilcon A) for Presbyopia (Comparator)
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
Phone: 5856032402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place