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

NCT06242860 | Completed FDA Device

• 1 other identifier: PTL 1011
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaporative Dry Eye Disease; Meibomian Gland Dysfunction

Keywords

dry eye disease; meibomian gland dysfunction; evaporative dry eye disease; eye lipid mobilizer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• SPEED II Questionnaire for Dry Eye

  one week, four weeks

• Slip Lamp Evaluation

  one week, four weeks

• Meibomian Gland Imaging

  one week, four weeks

• Lipid Layer Thickness

  one week, four weeks

• Tear Break Up Time

  one week, four weeks

Other Outcomes (1)

• Human Factors and Usability Evaluation

  one week, four weeks

Study Arms (2)

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.

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

Device: ELM

Interventions

ELM DEVICE

Treatment of dry eye with ELM device

Daily ELM Treatment; Single ELM Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 21 years old
• Confirmed evaporative dry eye disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyedetec Medical, Inc.: lead

Study Sites (1)

EYEcenter Optometric

Citrus Heights, California, 95662, United States

Location

Related Publications (3)

• 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.

  PMID: 25136628 RESULT

• 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.

  PMID: 25030896 RESULT

• 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.

  PMID: 19668387 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• CEO

  Eyedetec

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 5, 2024
• Study Start: February 8, 2022
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)