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

NCT06242860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-02-05

No results posted yet for this study

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

Interventions

DEVICE

ELM

Treatment of dry eye with ELM device

Sponsors & Collaborators

  • Eyedetec Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • CEO · Eyedetec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2022-03-14
Completion
2022-03-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242860 on ClinicalTrials.gov