Evaluation of the LipiFlow System With a New Activator

Johnson & Johnson (J&J)

Status: Completed

Conditions: Meibomian Gland Dysfunction

Treatments: Device: Activator LFD-2100

Study type: Interventional

Funder types: Industry

Identifiers

NCT04500821

DRYE-105-ACTS

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Activator LFD-2100

Experimental group

Description:

LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD

Treatment:

Device: Activator LFD-2100