Evaluation of the LipiFlow System With a New Activator

Not Applicable

Completed

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: Activator LFD-2100

• Registration Number: NCT04500821
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-10-02
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Results First Submitted: 2021-10-18
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Results First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activator LFD-2100	Activator LFD-2100	LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD

Primary Outcome Measures

Name	Time	Method
Successful Completion of LipiFlow Treatment With Activator LFD-2100	1 day after completion of LipiFlow treatment	Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100

Trial Locations

Locations (3)

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Texas Eye Research Center; 🇺🇸 Hurst, Texas, United States

Empire Eye and Laser Center; 🇺🇸 Bakersfield, California, United States