Evaluation of the LipiFlow System With a New Activator

NCT04500821 | Completed Results FDA Device

• 1 other identifier: DRYE-105-ACTS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Activator LFD-2100

EXPERIMENTAL

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

Device: Activator LFD-2100

Interventions

Activator LFD-2100 DEVICE

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

Activator LFD-2100

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (3)

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Texas Eye Research Center

Hurst, Texas, 76054, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Luis Vargas, MD
• Organization: Johnson & Johnson Surgical Vision

LVarga17@ITS.JNJ.com

714-247-8200

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical vision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 5, 2020
• Study Start: October 2, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)