Evaluation of the LipiFlow System With a New Activator

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500821
• Other study ID #: DRYE-105-ACTS
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2022
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• Activator LFD-2100
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD

Locations

Country	Name	City	State
United States	Empire Eye and Laser Center	Bakersfield	California
United States	Texas Eye Research Center	Hurst	Texas
United States	Wolstan & Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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