Novel Extranasal Tear Stimulation: Pivotal Study Results

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.