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

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

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.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction; Evaporative Dry Eye Disease
• Intervention / Treatment: Device: ELM

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Citrus Heights, California, United States, 95662
      • EYEcenter Optometric

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: ELM; Treatment of dry eye with ELM device
Active Comparator: 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	Device: ELM; Treatment of dry eye with ELM device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related adverse events	Incidence of procedure-related adverse events will be assessed	one week, four weeks
Device-related adverse events	Incidence of device-related adverse events will be assessed	one week, four weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Factors and Usability Evaluation	Patients will participate in an Acceptance VAS Questionnaire	one week, four weeks

Collaborators and Investigators

• Sponsor: Eyedetec Medical, Inc.
• Investigators: Study Director: CEO, Eyedetec

Publications and helpful links

General Publications

• Semeraro F, Forbice E, Braga O, Bova A, Di Salvatore A, Azzolini C. Evaluation of the efficacy of 50% autologous serum eye drops in different ocular surface pathologies. Biomed Res Int. 2014;2014:826970. doi: 10.1155/2014/826970. Epub 2014 Jul 22.
• Finis D, Pischel N, Konig C, Hayajneh J, Borrelli M, Schrader S, Geerling G. [Comparison of the OSDI and SPEED questionnaires for the evaluation of dry eye disease in clinical routine]. Ophthalmologe. 2014 Nov;111(11):1050-6. doi: 10.1007/s00347-014-3042-z. German.
• Savini G, Prabhawasat P, Kojima T, Grueterich M, Espana E, Goto E. The challenge of dry eye diagnosis. Clin Ophthalmol. 2008 Mar;2(1):31-55. doi: 10.2147/opth.s1496.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: meibomian gland dysfunction; dry eye disease; evaporative dry eye disease; eye lipid mobilizer
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: PTL 1011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will not be publishing in ICMJE journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No