Evaluation of the LipiFlow System With a New Activator

Completed · Not applicable

Conditions studied: Meibomian Gland Dysfunction

In brief

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.

Key facts

Study ID

NCT04500821

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

44

Starts

2020-10-02

Expected to finish

2020-10-30

Last updated by the study team

2022-01-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Empire Eye and Laser Center — Bakersfield, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Texas Eye Research Center — Hurst, Texas, United States

Full record on ClinicalTrials.gov

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