Meibomian Gland Dysfunction
Conditions
Brief summary
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.
Interventions
DEVICEActivator LFD-2100
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be able to participate in this study, subjects must: * Be at least 22 years old. * Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid. * Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit. * Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures. * Ability to understand and respond in English.
Exclusion criteria
Subject will not be able to be in the study, if the subject: * Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System * Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results. * Is pregnant, or is breast feeding. * Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Completion of LipiFlow Treatment With Activator LFD-2100 | 1 day after completion of LipiFlow treatment | Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100 |
Countries
United States
Participant flow
Pre-assignment details
A total of 88 eyes of 44 subjects with meibomian gland dysfunction were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Activator LFD-2100 Lipiflow treatment with Activator LFD-2100 | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Activator LFD-2100 |
|---|---|
| Age, Customized 30-39 years | 0 Participants |
| Age, Customized < 30 years | 0 Participants |
| Age, Customized 40-49 years | 1 Participants |
| Age, Customized 50-59 years | 6 Participants |
| Age, Customized 60-69 years | 19 Participants |
| Age, Customized >= 70 years | 18 Participants |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 42 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants |
| Sex: Female, Male Sex Female | 31 Participants |
| Sex: Female, Male Sex Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Successful Completion of LipiFlow Treatment With Activator LFD-2100
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Time frame: 1 day after completion of LipiFlow treatment
Population: All treated eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Activator LFD-2100 | Successful Completion of LipiFlow Treatment With Activator LFD-2100 | 100 Percent of eyes |