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

Not Applicable

Completed

• Conditions: Evaporative Dry Eye Disease; Meibomian Gland Dysfunction

• Registration Number: NCT06242860
• Lead Sponsor: Eyedetec Medical, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-02-08
• Primary Completion: 2022-03-14
• Study Completion: 2022-03-14
• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Procedure-related adverse events	one week, four weeks	Incidence of procedure-related adverse events will be assessed
Device-related adverse events	one week, four weeks	Incidence of device-related adverse events will be assessed

Secondary Outcome Measures

Name	Time	Method
Slip Lamp Evaluation	one week, four weeks	Change of appearance of cornea under slit lamp evaluation compared to baseline
Corneal Fluorescein Staining	one week, four weeks	Change in appearance of fluorescein staining compared to baseline
SPEED II Questionnaire for Dry Eye	one week, four weeks	Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline
Lipid Layer Thickness	one week, four weeks	Change in thickness of lipid layer compared to baseline
Meibomian Gland Imaging	one week, four weeks	Change in meibomian gland under imaging compared to baseline
Tear Break Up Time	one week, four weeks	Change in tear break up time compared to baseline

Trial Locations

Locations (1)

EYEcenter Optometric; 🇺🇸 Citrus Heights, California, United States