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NCT Number: NCT06242860

Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease

The goal of this clinical trial is to evaluate the Eye Lipid Mobilizer (ELM) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. The main questions aim to confirm that 1) the ELM can meet its intended use by validated patient reporting outcomes and 2) to confirm that the ELM device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.

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Key information

Conditions

Evaporative Dry Eye Disease Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EYEcenter Optometric

Citrus Heights, California, 95662, United States

About this study

The purpose of the clinical study is to evaluate the Eye Lipid Mobilizer for the treatment of evaporative Dry Eye Disease associated with Meibomian Gland Dysfunction. The objective of the study is to confirm that the Eye Lipid Mobilizer (ELM) can meet its intended use by validated patient reporting outcomes.

The secondary objective is the ELM device can be used safety with no adverse events. The Eye Lipid Mobilizer (ELM) System is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 21 years old
  • Confirmed evaporative dry eye disease

Exclusion criteria

  • Ocular surgery, trauma, herpes infections
  • Unwillingness to comply with study protocol
  • Pregnant or nursing women
  • Any subject that cannot wear an eye mask
  • Participation in another ophthalmic clinical trial within past 30 days

Treatment and study plan

ELM

Device

Treatment of dry eye with ELM device

Primary outcomes

  1. Procedure-related adverse events

    Time frame: one week, four weeks

    Incidence of procedure-related adverse events will be assessed

  2. Device-related adverse events

    Time frame: one week, four weeks

    Incidence of device-related adverse events will be assessed

Secondary outcomes

  1. SPEED II Questionnaire for Dry Eye

    Time frame: one week, four weeks

    Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline

  2. Slip Lamp Evaluation

    Time frame: one week, four weeks

    Change of appearance of cornea under slit lamp evaluation compared to baseline

  3. Meibomian Gland Imaging

    Time frame: one week, four weeks

    Change in meibomian gland under imaging compared to baseline

  4. Lipid Layer Thickness

    Time frame: one week, four weeks

    Change in thickness of lipid layer compared to baseline

  5. Tear Break Up Time

    Time frame: one week, four weeks

    Change in tear break up time compared to baseline

  6. Corneal Fluorescein Staining

    Time frame: one week, four weeks

    Change in appearance of fluorescein staining compared to baseline

Other outcomes

  1. Human Factors and Usability Evaluation

    Time frame: one week, four weeks

    Patients will participate in an Acceptance VAS Questionnaire

Sponsors and collaborators

Lead sponsor

Eyedetec Medical, Inc.

Industry

Registry information

Official study title

A Prospective, Clinical Trial Eye Lipid Mobilizer (ELM) Using Heat and Vibration for the Treatment of Meibomian Gland Dysfunction (MGD)

Acronym: ELM

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

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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