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OpenTrials
Completed

NCT Number: NCT04500821

Evaluation of the LipiFlow System With a New Activator

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.

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Key information

Conditions

Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Empire Eye and Laser Center, Bakersfield, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activator LFD-2100

Device

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

Primary outcomes

  1. Successful Completion of LipiFlow Treatment With Activator LFD-2100

    Time frame: 1 day after completion of LipiFlow treatment

    Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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