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

Meibomian Gland Dysfunction Clinical Trial

— ELM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06242860
• Other study ID #: PTL 1011
• Status: Completed
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: March 14, 2022

Study information

• Verified date: January 2024
• Source: Eyedetec Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye Disease
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Device:
• ELM
Treatment of dry eye with ELM device

Locations

Country	Name	City	State
United States	EYEcenter Optometric	Citrus Heights	California

Sponsors (1)

Lead Sponsor	Collaborator
Eyedetec Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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- — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Human Factors and Usability Evaluation	Patients will participate in an Acceptance VAS Questionnaire	one week, four weeks
Primary	Procedure-related adverse events	Incidence of procedure-related adverse events will be assessed	one week, four weeks
Primary	Device-related adverse events	Incidence of device-related adverse events will be assessed	one week, four weeks
Secondary	SPEED II Questionnaire for Dry Eye	Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline	one week, four weeks
Secondary	Slip Lamp Evaluation	Change of appearance of cornea under slit lamp evaluation compared to baseline	one week, four weeks
Secondary	Meibomian Gland Imaging	Change in meibomian gland under imaging compared to baseline	one week, four weeks
Secondary	Lipid Layer Thickness	Change in thickness of lipid layer compared to baseline	one week, four weeks
Secondary	Tear Break Up Time	Change in tear break up time compared to baseline	one week, four weeks
Secondary	Corneal Fluorescein Staining	Change in appearance of fluorescein staining compared to baseline	one week, four weeks