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Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activator LFD-2100 | Experimental | LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activator LFD-2100 | Device | LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Completion of LipiFlow Treatment With Activator LFD-2100 | Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100 | 1 day after completion of LipiFlow treatment |
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Inclusion Criteria:
To be able to participate in this study, subjects must:
Exclusion Criteria:
Subject will not be able to be in the study, if the subject:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye and Laser Center | Bakersfield | California | 93309 | United States | ||
| Wolstan & Goldberg Eye Associates |
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
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A total of 88 eyes of 44 subjects with meibomian gland dysfunction were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Activator LFD-2100 | Lipiflow treatment with Activator LFD-2100 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Activator LFD-2100 | Lipiflow treatment with Activator LFD-2100 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Successful Completion of LipiFlow Treatment With Activator LFD-2100 | Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100 | All treated eyes | Posted | Number | 95% Confidence Interval | Percent of eyes | 1 day after completion of LipiFlow treatment | Eyes | Eyes |
|
|
During the course of the study until completion, 1 up to 2 days.
Analysis population include all eyes (88 eyes) of 44 participants treated with Lipiflow with Activator LFD-2100. All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for each eye separately.
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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 | Right Eye (OD) | LipiFlow treatment with Activator LFD-2100 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luis Vargas, MD | Johnson & Johnson Surgical Vision | 714-247-8200 | LVarga17@ITS.JNJ.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2020 | Oct 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2020 | Oct 18, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Torrance |
| California |
| 90505 |
| United States |
| Texas Eye Research Center | Hurst | Texas | 76054 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Eyes |
|
|
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Left Eye (OS) | LipiFlow treatment with Activator LFD-2100 | 0 | 44 | 0 | 44 | 0 | 44 |
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.