Evaporative Dry Eye Disease, Meibomian Gland Dysfunction
Conditions
Keywords
dry eye disease, meibomian gland dysfunction, evaporative dry eye disease, eye lipid mobilizer
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.
Interventions
DEVICEELM
Treatment of dry eye with ELM device
Sponsors
Eyedetec Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-related adverse events | one week, four weeks | Incidence of device-related adverse events will be assessed |
| Procedure-related adverse events | one week, four weeks | Incidence of procedure-related adverse events will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slip Lamp Evaluation | one week, four weeks | Change of appearance of cornea under slit lamp evaluation 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 |
| Corneal Fluorescein Staining | one week, four weeks | Change in appearance of fluorescein staining compared to baseline |
| Lipid Layer Thickness | one week, four weeks | Change in thickness of lipid layer 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Human Factors and Usability Evaluation | one week, four weeks | Patients will participate in an Acceptance VAS Questionnaire |
Countries
United States
Outcome results
None listed