Evaporative Dry Eye DiseaseELMNCT06242860
Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease
A study testing ELM in people with Evaporative Dry Eye Disease and Meibomian Gland Dysfunction, run by Eyedetec Medical, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaporative Dry Eye Disease, Meibomian Gland Dysfunction
- What is being tested?
- ELM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years old
- Confirmed evaporative dry eye disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
EYEcenter Optometric
Citrus Heights, California, 95662
About this study
Official title: 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.
Read the 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.
- Being tested
- ELM
- Keywords
- dry eye disease, meibomian gland dysfunction, evaporative dry eye disease, eye lipid mobilizer
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELMDevice
Treatment of dry eye with ELM device
| Study group | Role | What they receive |
|---|---|---|
| Single ELM Treatment | Active comparator | 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. Receives: Device: ELM |
| Daily ELM Treatment | Active comparator | 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 Receives: Device: ELM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related adverse events
Incidence of procedure-related adverse events will be assessed
Measured: one week, four weeks
Device-related adverse events
Incidence of device-related adverse events will be assessed
Measured: one week, four weeks
Secondary outcomes (6)
SPEED II Questionnaire for Dry Eye
Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline
Measured: one week, four weeks
Slip Lamp Evaluation
Change of appearance of cornea under slit lamp evaluation compared to baseline
Measured: one week, four weeks
Meibomian Gland Imaging
Change in meibomian gland under imaging compared to baseline
Measured: one week, four weeks
Lipid Layer Thickness
Change in thickness of lipid layer compared to baseline
Measured: one week, four weeks
Tear Break Up Time
Change in tear break up time compared to baseline
Measured: one week, four weeks
Corneal Fluorescein Staining
Change in appearance of fluorescein staining compared to baseline
Measured: one week, four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start8 Feb 2022
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Evaporative Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyedetec Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CEO, Study director, Eyedetec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242860
- Sponsor's protocol ID
- PTL 1011
- Acronym
- ELM
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: will not be publishing in ICMJE journals
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.
PubMed 25136628Finis 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.
PubMed 25030896Savini 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.
PubMed 19668387
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Clinical Trial Eye Lipid Mobilizer (ELM) Using Heat and Vibration for the Treatment of Meibomian Gland Dysfunction (MGD)
- ClinicalTrials.gov ID
- NCT06242860
- Acronym / sponsor ID
- ELM / PTL 1011
- Keywords
- dry eye disease, meibomian gland dysfunction, evaporative dry eye disease, eye lipid mobilizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Eyedetec Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ELM Treatment | Active comparator | Device: ELMTo 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. |
| Daily ELM Treatment | Active comparator | Device: ELMTo 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 21 years old
- Confirmed evaporative dry eye disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELMTreatment of dry eye with ELM device | Device | Daily ELM Treatment, Single ELM Treatment |
Primary outcome
Procedure-related adverse events
Time frame: one week, four weeks
Incidence of procedure-related adverse events will be assessed
Device-related adverse events
Time frame: one week, four weeks
Incidence of device-related adverse events will be assessed
6 secondary outcomes
SPEED II Questionnaire for Dry Eye
Time frame: one week, four weeks
Slip Lamp Evaluation
Time frame: one week, four weeks
Meibomian Gland Imaging
Time frame: one week, four weeks
Lipid Layer Thickness
Time frame: one week, four weeks
Tear Break Up Time
Time frame: one week, four weeks
Corneal Fluorescein Staining
Time frame: one week, four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Results publication: PubMed 25136628Semeraro 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.
- Results publication: PubMed 25030896Finis 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.
- Results publication: PubMed 19668387Savini 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.
- Individual participant dataSharing planned: No. will not be publishing in ICMJE journals
Related trials for Evaporative Dry Eye Disease
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Dry Eye Disease, Dry Eye
Not yet recruitingPhase 4
Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye
Evaporative Dry Eye Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CEO study director
Eyedetec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELM in people with Evaporative Dry Eye Disease and Meibomian Gland Dysfunction, run by Eyedetec Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related adverse events (time frame: one week, four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242860, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.