Evaluation of the LipiFlow System With a New Activator

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Activator LFD-2100


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activator LFD-2100<br>LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD | Device: Activator LFD-2100<br>* LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |