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

Eyedetec Medical

Status: Completed

Conditions: Evaporative Dry Eye Disease; Meibomian Gland Dysfunction

Treatments: Device: ELM

Study type: Interventional

Funder types: Industry

Identifiers

NCT06242860

PTL 1011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Single ELM Treatment

Active Comparator group

Description:

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.

Treatment:

Device: ELM

Daily ELM Treatment

Active Comparator group

Description:

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

Treatment:

Device: ELM