Clinical trial NCT06242860: Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease
Official title: A Prospective, Clinical Trial Eye Lipid Mobilizer (ELM) Using Heat and Vibration for the Treatment of Meibomian Gland Dysfunction (MGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaporative Dry Eye Disease
Meibomian Gland Dysfunction
Keywords: dry eye disease
meibomian gland dysfunction
evaporative dry eye disease
eye lipid mobilizer
Lead sponsor: Eyedetec Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure-related adverse events
timeFrame: one week, four weeks
measure: Device-related adverse events
timeFrame: one week, four weeks
Secondary outcomes:
measure: SPEED II Questionnaire for Dry Eye
timeFrame: one week, four weeks
measure: Slip Lamp Evaluation
timeFrame: one week, four weeks
measure: Meibomian Gland Imaging
timeFrame: one week, four weeks
measure: Lipid Layer Thickness
timeFrame: one week, four weeks
measure: Tear Break Up Time
timeFrame: one week, four weeks
measure: Corneal Fluorescein Staining
timeFrame: one week, four weeks
Other outcomes:
measure: Human Factors and Usability Evaluation
timeFrame: one week, four weeks
Locations:
city: Citrus Heights
country: United States
facility: EYEcenter Optometric
state: California
Study officials:
affiliation: Eyedetec
name: CEO
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.