Evaporative Dry Eye, Meibomian Gland Dysfunction
Conditions
Brief summary
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.
Detailed description
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.
Interventions
DEVICEiLux 2020 System
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
Sponsors
Tear Film Innovations, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: \- Sign written informed consent prior to study participation Key
Exclusion criteria
* History of ocular surgery within 1 year * Active ocular infection * Ocular surface abnormality; lid surface abnormalities * Pregnant, nursing or not utilizing adequate birth control measures * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment | Day 0 immediately post-treatment | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one investigative site located in the United States.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| iLux 2020 System Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | iLux 2020 System |
|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 15.1 |
| Race/Ethnicity, Customized Hispanic/Latino | 1 participants |
| Race/Ethnicity, Customized Not Reported | 3 participants |
| Race/Ethnicity, Customized White | 11 participants |
| Region of Enrollment United States | 15 participants |
| Sex/Gender, Customized Male | 7 participants |
| Sex/Gender, Customized Not reported | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
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.
Time frame: Day 0 immediately post-treatment
Population: Safety Analysis Set: All subjects enrolled and treated
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux 2020 System | Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment | Corneal temperature | 37.7 degrees Celsius | Standard Deviation 0.5 |
| iLux 2020 System | Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment | Eyelid temperature | 38.5 degrees Celsius | Standard Deviation 0.8 |
| iLux 2020 System | Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment | Surface temperature | 38.2 degrees Celsius | Standard Deviation 0.7 |