Trial Outcomes & Findings for Tear Film Innovations iLux Safety Study (NCT NCT03055897)
NCT ID: NCT03055897
Last Updated: 2023-04-12
Results Overview
Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified.
COMPLETED
NA
15 participants
Day 0 immediately post-treatment
2023-04-12
Participant Flow
Participants were recruited from one investigative site located in the United States.
This reporting group includes all enrolled participants.
Participant milestones
| Measure |
iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tear Film Innovations iLux Safety Study
Baseline characteristics by cohort
| Measure |
iLux 2020 System
n=15 Participants
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
7 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not reported
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 immediately post-treatmentPopulation: Safety Analysis Set: All subjects enrolled and treated
Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified.
Outcome measures
| Measure |
iLux 2020 System
n=30 eyes
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
|---|---|
|
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
Corneal temperature
|
37.7 degrees Celsius
Standard Deviation 0.5
|
|
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
Eyelid temperature
|
38.5 degrees Celsius
Standard Deviation 0.8
|
|
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
Surface temperature
|
38.2 degrees Celsius
Standard Deviation 0.7
|
Adverse Events
iLux 2020 System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior CDMA Project Lead, CDMA Ocular Health
Alcon Research, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER