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If you are left a little baffled by your first glance at TrueTear, Allergan's recently FDA approved intranasal tear neurostimulator, you aren't alone. The idea of a device inserted in your nose to produce natural tears gets a lot of confused glances. Although you're first instinct is to think this device somehow causes your eyes to water in the manner they do when you pluck a nose hair, think again. This device actually helps patients emit their own, normal and natural tears -- not an irritation driven watering response.

What is it?

Neurostimulators have been around for decades, but the technology is new for the world of eyecare. Common neurostimulator devices used in everyday healthcare include pacemakers and cochlear implants for hearing loss.  TrueTear is a neurostimulation device that emits micro-electric pulses to the nasal cavity to stimulate the lacrimal gland and the trigeminal nerve (Cranial Nerve V). The device must be inserted into the nasal cavity far enough to contact nasal mucus membrane with trigeminal nerve branches (a technique that may require some training to do correctly). To prevent infection risk, the tip that contacts the nasal mucus is disposed of daily.

The branches of the Trigeminal Nerve (or Cranial Nerve 5) extend to the mouth, nose, and eyes. via

Why is the eyecare world so excited about this new technology?  It's the first dry eye treatment that results in immediate increase to tear production, and unlike eye drops, it does not involve any chemicals and their potential side effects from entering the body. It is a treatment that could be used as needed, as much or as little as a patient needs for dry eye relief, leaving the patient in charge of controlling their signs and symptoms of dry eye.

The Clinical Data
In a study of 48 adults diagnosed with dry eye disease (as defined by a Schirmer's score of less than 10 mm in 5 minutes and an OSDI score of at least 13), the TrueTear device produced significant increase to aqueous tearing compared to an intranasal device sham control. An average Schirmer score of 25.3 mm ± 10.7 was observed during active neurostimulation, compared with only 9.2 mm ± 7.3 for the sham control application. The mean difference between Schirmer score with active stimulation versus sham was 16.1 mm.

A second study of 97 adults evaluated aqueous deficient dry eye patients for 6 months comparing a treated eye to an untreated fellow eye in the same patients. The inclusion criteria for enrolling in this study was a baseline OSDI score of at least 23, a baseline Schirmer test with anesthetic of ≤ 10 mm in 5 minutes, and corneal fluorescein staining in the same eye. Patients were instructed to use the device at least twice a day for no longer than 3 minutes at a time, and no more than 10 times a day for the enrolled "study eye."  The fellow eye was not to be to stimulated. Patients were seen for follow-up on day 7, 30, 90, and 180.

The mean difference in Schirmer score (stimulated eye versus unstimulated) was

•  18.0 mm on day 0
•  13.1 mm on day 7
•  8.1 mm on day 30
•  8.3 mm on day 90
•  9.4 mm on day 180. 

Based on these results it does appear that the initial tear production response to TrueTear is greater than it's continued response with time, and with continued use the effectiveness settles to a stable level after about 1 month of use.

There were no serious adverse events reported in either clinical study.  The most common side effects were "nasal discomfort" at 10.3%. Colloquial reports from company representatives stay that the device emits a "tingling" sensation, that could be strong enough to cause a sneeze when used on higher settings. That is why starting on a lower level device setting is advisable and only turning the voltage up if no sensation occurs.


This device is NOT approved for

• patients with implanted neurostimulator devices like pacemakers or wearable defibrillators
• patients under 22 years old or pregnancy (it's safety has not been studied at this time)
• use in water (a bath or shower), or around flammable gasses or shortwave devices
• patients with nasal or sinus surgery or untreated nasal infections
• patients with chronic or frequent nosebleeds, a bleeding disorder (eg, hemophilia), or another condition that can lead to increased bleeding 
• patients with a known allergy to the hydrogel material the nasal tip is made from

How often would my patients use this? 
Allergan recommends starting with twice daily use at Level 2 setting, with stimulation times of up to 3 minutes per use for patients with dry eye disease and aqueous deficiency. The maximum usage possible is 10 times a day (the device is limited to only 30 total minutes of neurostimulation per day). There are multiple voltage settings, levels 1 to 5, to provide increasing levels of stimulation. Allergan is reporting up to 4 hours of improved tear production per use.

The patient will need training by their doctor on how to use and properly insert the device. via

Where can I get it?
At this time, Allergan is doing a limited roll-out to selected clinics specializing in dry eye. Later in the year broader availability is expected. Patients will be buying the TrueTear device itself, and packages of the nasal tip covers that require daily replacement. There has been no statement at this time about proposed costs. TrueTear is a prescription medical device that will require a physician's prescription, and training on its use.