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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iLux 2020 System | Experimental | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iLux 2020 System | Device | Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 immediately post-treatment |
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Key Inclusion Criteria:
- Sign written informed consent prior to study participation
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. CDMA Project Lead, CDMA Ocular Health | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TearFilm Innovations Investigative Site | Encinitas | California | 92924 | United States |
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This reporting group includes all enrolled participants.
Participants were recruited from one investigative site located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | iLux 2020 System | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | iLux 2020 System | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set: All subjects enrolled and treated | Posted | Mean | Standard Deviation | degrees Celsius | Day 0 immediately post-treatment | eyes | eyes |
|
|
Adverse event data was collected for each participant from time of enrollment until time of study exit, approximately 2 days.
An adverse event was defined as any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. All participants exposed to the study treatment were evaluated for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iLux 2020 System | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior CDMA Project Lead, CDMA Ocular Health | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2016 | Nov 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| years |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
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| eyes |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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