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Nasolacrimal Lavage as a Treatment for Ocular Surface Toxic Soup Syndrome

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Novel Extranasal Tear Stimulation: Pivotal Study Results.

Marco H Ji^1,2, Darius M Moshfeghi¹, Laura Periman³

¹Horngren Family Vitreoretinal Center, Byers Eye Institute, Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, CA, USA.

Translational Vision Science & Technology

|November 27, 2020

Summary

The iTEAR device effectively improved dry eye disease (DED) symptoms and tear production in patients. This novel neuromodulation treatment demonstrated safety and efficacy for DED management.

Keywords:

dry eye disease dry eyes lacrimal gland neurostimulation

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Area of Science:

Ophthalmology
Neuromodulation
Medical Devices

Background:

Dry eye disease (DED) is a prevalent condition affecting millions globally.
Current DED treatments have limitations, necessitating novel therapeutic approaches.
External neuromodulation offers a potential non-invasive strategy for DED management.

Purpose of the Study:

To assess the efficacy and safety of the iTEAR device, a portable sonic neuromodulation tool, for treating dry eye disease (DED).
To evaluate the impact of external nasal nerve stimulation on tear production and DED symptoms.

Main Methods:

A multicenter, open-label, single-arm clinical trial involving adult patients diagnosed with DED.
Participants used the iTEAR device bilaterally on the external nasal nerve twice daily for 30 seconds.
Primary efficacy endpoint: change in Schirmer index at day 30. Secondary endpoint: change in Ocular Surface Disease Index (OSDI) scores.

Main Results:

The iTEAR device significantly improved the Schirmer index (mean change 9.4 mm) and reduced OSDI scores (mean improvement 14.4) by day 30.
Statistically and clinically significant improvements were observed across all time points.
The treatment was well-tolerated, with only two mild adverse events reported.

Conclusions:

The iTEAR device demonstrates favorable safety and efficacy for the treatment of dry eye disease (DED).
External nasal nerve stimulation via the iTEAR device is a promising therapeutic option for DED.
Further research may explore long-term outcomes and broader applications of this neuromodulation technology.