Evaluation of the LipiFlow System With a New Activator

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

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.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Activator LFD-2100

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye and Laser Center
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Texas
    • Hurst, Texas, United States, 76054
      • Texas Eye Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activator LFD-2100; LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD	Device: Activator LFD-2100; LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: DRYE-105-ACTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No