Trial Outcomes & Findings for Evaluation of the LipiFlow System With a New Activator (NCT NCT04500821)
NCT ID: NCT04500821
Last Updated: 2022-01-24
Results Overview
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
1 day after completion of LipiFlow treatment
Results posted on
2022-01-24
Participant Flow
A total of 88 eyes of 44 subjects with meibomian gland dysfunction were enrolled.
Unit of analysis: Eyes
Participant milestones
| Measure |
Activator LFD-2100
Lipiflow treatment with Activator LFD-2100
|
|---|---|
|
Overall Study
STARTED
|
44 88
|
|
Overall Study
COMPLETED
|
44 88
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the LipiFlow System With a New Activator
Baseline characteristics by cohort
| Measure |
Activator LFD-2100
n=44 Participants
Lipiflow treatment with Activator LFD-2100
|
|---|---|
|
Age, Customized
< 30 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
30-39 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
6 Participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
19 Participants
n=99 Participants
|
|
Age, Customized
>= 70 years
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Sex · Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Sex · Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
42 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 day after completion of LipiFlow treatmentPopulation: All treated eyes
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Outcome measures
| Measure |
Activator LFD-2100
n=88 Eyes
LipiFlow treatment with Activator LFD-2100
|
|---|---|
|
Successful Completion of LipiFlow Treatment With Activator LFD-2100
|
100 Percent of eyes
Interval 96.0 to 100.0
|
Adverse Events
Right Eye (OD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Left Eye (OS)
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 The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
- Publication restrictions are in place
Restriction type: OTHER