Trial Outcomes & Findings for Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens (NCT NCT05660577)
NCT ID: NCT05660577
Last Updated: 2024-04-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
3 weeks
Results posted on
2024-04-09
Participant Flow
Participant milestones
| Measure |
e Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
|
|---|---|
|
Overall Study
STARTED
|
301
|
|
Overall Study
COMPLETED
|
292
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
e Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
|
|---|---|
|
Overall Study
Discontinued
|
9
|
Baseline Characteristics
Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
Baseline characteristics by cohort
| Measure |
Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens
n=294 Participants
New silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
|
|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 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
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
252 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
294 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksOutcome measures
| Measure |
Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens
n=294 Participants
New silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
|
|---|---|
|
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
|
241 Participants
|
Adverse Events
Bausch + Lomb (Kalifilcon A) Daily Disposable Multifocal Contact Lens
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place