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Evaluation of the LipiFlow System With a New Activator

CompletedNA

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Conditions: Meibomian Gland Dysfunction

Interventions: Activator LFD-2100

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

Bakersfield, California, United States
Torrance, California, United States
Hurst, Texas, United States