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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2022-03-14

Brief Summary

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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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Detailed Description

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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.

Conditions

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Evaporative Dry Eye Disease Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single ELM Treatment

To undergo the ELM procedure, the subject will sit comfortably in an exam chair.

The Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed.

Group Type ACTIVE_COMPARATOR

ELM

Intervention Type DEVICE

Treatment of dry eye with ELM device

Daily ELM Treatment

To undergo the ELM procedure, the subject will sit comfortably in an exam chair.

The Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed. Subject will take personalized ELM home and use it as directed on a daily basis

Group Type ACTIVE_COMPARATOR

ELM

Intervention Type DEVICE

Treatment of dry eye with ELM device

Interventions

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ELM

Treatment of dry eye with ELM device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes