True Tear: Does it Work? How Much Does True Tear Cost?

We have been eagerly awaiting the launch of True Tear. My sister worked on the oculoplastics part of this machine at Stanford and she has used it on herself multiple times. She was hired as a temporary consultant but has no stock in the company. I have no stock in the company either and am not a consultant. 


It appears True Tear does work and that it does likely stimulate the goblet cells and meibomian gland cells to produce. However, I have not seen any improvement in meibography with True Tear. Also there are some concerns on the quality of the studies and there are many patient who feel it did not help them.


Currently, True Tear is offered at most locations for around $700-1100. Most insurances do not reimburse for True Tear, so it is an expensive piece of dry eye equipment.

How Does True Tear Work And Why Does “Picking Your Nose” NOT work as well:

I am still not 100% sure I can answer the last part of this question since someone who really sticks a q tip, feather, rolled up tissue, or finger high up in the nose can induce stimulate the nerve that induces sneezing, tearing, and even salivation. 

True Tear works via neurostimulation. It stimulates Cranial Nerve V’s first branch called the Ophthalmic Branch V1: this in turn stimulates/innervates the Lacrimal Gland, the Meibomian Glands, and the Goblet Cells.  True Tear 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 and which can be frustrating to patients. 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. 


What are the Positives of True Tear: First it does not involve the use of any preservatives or chemicals on the eye. Second, it usually increase tear production immediately. Third, there is evidence to show it increases meibomian gland lipid production. Fourth, it can be used as needed by the patient. Fifth, it seems to be very safe with no long term risks. 


The Clinical Data
The True Tear Data has come under some fire. In brief: 
https://www.healthnewsreview.org/news-release-review/claims-aplenty-despite-lack-of-demonstrated-clinical-benefit-from-allergans-new-device-for-dry-eyes/
In a study of 48 adults diagnosed with dry eye disease, 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.  The most common side effects were “nasal discomfort” at 10.3%. Reps report that the device emits a “tingling” sensation, that could be strong enough to cause a sneeze when used on higher settings. Dr. White below noted excessive sneezing initially that subsided after frequent use. 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? 
The company 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.

Future Studies:

I must admit I have a crazy research idea: does True Tear help shorten the course of a cold or sinus infection? I have always suspected that people who make themselves sneeze early on in a cold, shorten the course of their cold. I wonder if True Tear’s use early on in a cold could shorten the cold’s duration because it makes one sneeze more….just an idea. 




References:






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

https://www.truetear.com/Content/pdfs/TrueTear-frequently-asked-questions.pdf

This is a very funny review of True Tear by an eye surgeon. But he is a consultant.


TrueTear: The latest buzz

Neurostimulation produces mucin, aqueous and lipid, the elements of a complete tear.
Ocular Surgery News U.S. Edition, August 25, 2017
Darrell E. White, MD
“It was a scratch, not a pick!” 
– Jerry Seinfeld
Once in a very long time, something comes along in our eye care world and just electrifies everyone. Taking the pulse of the community finds pretty much everyone charged up about it. As if the dry eye space isn’t hot enough, along comes TrueTear to stimulate the masses.

I’ll be appearing here all night.
By this time you are doubtless aware of the Oculeve story. Young inventor Michael Ackermann translates an aha moment — when you simulate the nose by, say, a gentle tap with a boxing glove, you make tears — and creates an instrument to do just that. “Oculeve” is born after Ackerman rounds up some venture capital usual suspects. A couple of proof-of-concept demonstrations are followed by a successful trial or two, and SHAZAM, Allergan scoops up Oculeve and rebrands it TrueTear.

The science behind TrueTear

There is science here that most of us have not given a whole heck of a lot of thought to since the first year of medical school. The trigeminal nerve has three divisions. Did you remember that the first division (V1) is also called the ophthalmic nerve? Me either. V1 innervates the lacrimal gland, goblet cells and the meibomian glands, collectively referred to as the lacrimal functional unit, or LFU. V1 is further subdivided into the frontal, lacrimal and nasociliary nerves. That is the one that is famous for giving us Hutchinson’s sign of blisters on the tip of the nose in shingles. Note to Brent Saunders: The Hutchinson estate should get royalty payments.
Fifteen years ago we started to see slides depicting the circular feedback loop between the ocular surface and the brainstem. While we think of the trigeminal nerve as primarily a sensory nerve, there is both afferent (sensory) and efferent (end-organ stimulation) flow along V1. These now-famous Allergan slides show that disrupting this circular flow at the afferent end, by inflammation for example, can lead to DED. Afferent signals from the LFU and ocular surface land in the trigeminal nucleus in the brainstem and are processed in the pons. Return flow occurs across both sympathetic and parasympathetic fibers and can result in activation of all three elements of the LFU.


TrueTear takes advantage of the fact that there are fibers of the nasociliary nerve close to the mucosal surface inside the nose. Your “target area” is just under the spot where glasses sit. The soft silicone gel tips of the TrueTear unit easily access this area. Once in contact with the inner surface of the nose, you simply press the large button in the middle of an instrument that looks kind of like one of those disposable leg shaver “egg” things, and BINGO — 
Does it work? You bet it does. Contrary to what most people assume, especially most people who have been punched in the nose, TrueTear produces more than just a reflex flood of aqueous tears from the lacrimal gland. In fact, the entire LFU is stimulated. What results is an increase in what can only be described as a complete tear. All three of the elements in a natural tear — mucin, aqueous and lipid — are found in essentially normal proportions in the tears that follow TrueTear stimulation of V1.
But does it really work? Is there a significant effect on DED on real, live people? Again, you bet it does. Eighty DED docs, your humble scribe included, had a chance to learn about TrueTear and give it a whirl along with some of our staff members. On its lowest of five power settings, TrueTear produced a significant flow of tears in my eyes after 5 seconds every single time. Like some 50% of people, I then went on to sneeze at 8 seconds every single time. (Allergan researchers tell us that this tends to go away with time.) I have had significant symptomatic DED for 30+ years; my eyes felt fantastic for hours after my TrueTear treatment.

Heck, Preeya Gupta has a deviated septum. She was amazed to find that she could actually breathe out of her left nostril for the first time in 15 years. (Off-label indication; very colorful personal communication.)

How it will work

TrueTear has been rolled out in what could be called a “soft release” to those 80 DED docs. It is more like an alpha trial of the business model, and it may or may not resemble what things will look like when TrueTear is widely available. Having said that, there are certain aspects of this trial that will extend into the general release. The base unit is a rechargeable instrument that will be sold as a durable medical good. Think insulin pump and you get the idea. Those silicone gel tips will then be sold by prescription in packs of 30. Each tip can be reused for 24 hours after its first “fire” for a total of 60 minutes of stimulation, more than enough to last 24 hours before it is disabled. Both instrument and tips will be eligible for insurance coverage.
It is fascinating to think about who might be in the target market for TrueTear. Obvious candidates include severe DED patients who are literally out of options and those individuals who simply cannot manipulate eye drop dispensers of any kind. What is really fun is to give a bit of free reign to your imagination for the rest. How about busy executives who spend all day in front of a screen, especially those who might wear eye makeup that would be ruined by applying artificial tears? One only has to suffer a single cross-country red eye to realize how handy a couple of TrueTear zaps might be if you have a meeting on the other end of that flight, like Laura Periman discovered. There are videos showing that prolonged stimulation can actually bring forth secretions from meibomian glands that are producing thick, semi-solid meibum. The possibilities are bounded only by our imagination.
Kind of like the possibilities to have some fun with this: bounded only by our imagination. Let’s be honest, everything about this fairly screams funny. Your eyes are dry and you need some tears, so you stick this thing up your nose and “light it up.” Can’t you just see it at those 0-dark-30 pre-dawn sessions at AAO and ASCRS? Everybody getting “buzzed” so that they can see the slides? Seinfeld gives us the obvious response when someone “catches” us using TrueTear: It’s a pulse, not a pick!
Be sure to tip your bartenders and waiters.
  • For more information:
  • Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: dwhite2@skyvisioncenters.com.
Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.







FREQUENTLY ASKED QUESTIONS


Frequently Asked Questions


Do I need a prescription to use the device?


Yes. You need a prescription from your eye care professional to obtain the TrueTear™ device.


How and where can I purchase the device?
The TrueTear™ device is a prescription-only device.
Ask your eye care professional about TrueTear™.


Is there a warranty available for the device?


Allergan warrants to the original purchaser of the TrueTear™ device that the device is free from defects
in materials and workmanship for three (3) years from the date of original purchase. This warranty
extends to only the original purchaser and is not transferable. Keep your invoice or receipt safe as this
is your proof of purchase, and the date marked on it shall be deemed the date of purchase. For all
warranty terms and conditions, please see the Instructions for Use that accompanied your TrueTear™
device or truetear.com.


USING THE DEVICE


How far do I need to insert the tip into my nose?


Insert the tip into your nose as far as is comfortable. Make sure the tip is inserted all the way to the top
and front of the nose.


How do I know if the stimulation is working?


You are stimulating the correct location if you feel a tingling sensation in your nose and your eyes begin
to tear.


How soon will I feel my eyes tear?


Tearing can occur within seconds. Depending on your individual anatomy and tear deficiency, tearing
can take a shorter or longer time.


What stimulation level do I have to use to tear?
Stimulation intensity level is different for every patient and can vary on any given day. The TrueTear™
device allows you to adjust your intensity level according to your own needs. Most patients started at
level 2 in the clinical trial.
Please see Indication and Important Safety Information on page 6.


FREQUENTLY ASKED QUESTIONS
3
Does it matter if I stimulate for 30 seconds or 3 minutes?
Stimulation can vary depending on the individual patient. Stimulate until you see/feel tear production.
Stimulation longer than 3 minutes is not recommended, and the patient should wait for at least 60
minutes before stimulating again.
How often and how long do I need to use the device?
The device is capable of single-day stimulation up to a limit of 30 minutes. Stimulation longer than
3 minutes per session is not recommended, and the patient should wait for at least 60 minutes before
stimulating again. For most patients, using the device at least twice a day as needed is recommended.
Refer to the Instructions for Use or check with your eye doctor.
Can I use the device in the shower?
No. Do not use the TrueTear™ device in the bath or shower.
How long do I need to charge the device?
Charging time is dependent on how often you use the device. It normally takes 4 hours to complete
a full charge. We recommend charging the device overnight.
My device shuts off automatically after 1 minute. Is this normal?
Yes. The TrueTear™ device has a built-in timer allowing for 1 minute of stimulation each time. For longer
stimulation time, simply start another cycle, although stimulation longer than 3 minutes per session is
not recommended, and the patient should wait for at least 60 minutes before stimulating again.


SIDE EFFECTS
Will I experience nasal pain while using TrueTear™?
In a 180-day study, 10 out of 97 patients (10.3%) reported nasal pain, discomfort or burning. If you
experience pain, discomfort or burning while using TrueTear™, remove the device immediately and
report this adverse event to 1-800-678-1605 and talk to your eye doctor.
Is it possible to feel an electrical shock in my nose when the TrueTear™
tip is inserted?
In a 180-day study, 5 out of 97 patients (5.2%) reported temporary electrical discomfort (a mild shock).
If you feel a mild shock while using TrueTear™, remove the device immediately and report this adverse
event to 1-800-678-1605 and talk to your eye doctor.
Please see Indication and Important Safety Information on page 6.


FREQUENTLY ASKED QUESTIONS


Can using TrueTear™ cause nosebleeds?


In a 180-day study, 5 out of 97 patients (5.2%) reported a device-related nosebleed. If your nose begins
to bleed while using TrueTear™, remove the device immediately and report this adverse event to
1-800-678-1605 and talk to your doctor.


Should I be aware of any other side effects?


There were additional side effects reported during the clinical studies. For a complete list of additional
adverse events, please consult the


Instructions for Use.
DISPOSABLE TIPS


Can I use the tip for more than one day?
No. The tip should be replaced daily or every 24 hours. The tip contains a hydrogel that wears down
after one day of use. Once the hydrogel is dried out, the tip will no longer provide stimulation.
Additionally, make sure to use the tip before the expiration date printed on the packaging.


Can I clean the tip by running it under hot or cold water?
No. To clean the TrueTear™ device, you can use an alcohol pad to gently wipe the daily disposable
tip, being careful not to rub the hydrogel areas.


How do I clean my base unit, charger, and cover?
Use alcohol pads to clean the durable parts of the device including the base, charger, and cover.
Clean the inside of the cover weekly or more often as needed to ensure proper hygiene.


Are the tip and cover dishwasher safe?
No, they are not. The best way to clean them is by wiping them with alcohol pads.


Can I throw the tip away in a regular trash can?
Yes. The TrueTear™ daily diposable tip can go in the regular trash for disposal.
Please see Indication and Important Safety Information on page 6.




FREQUENTLY ASKED QUESTIONS:
MOBILE APP


What does the TrueTear™ mobile app do?
The app is designed to help you view and track your device usage and battery level, learn more ways
for using the device, and get assistance if you encounter any problems with the device. Since
environmental conditions such as humidity, temperature, pollen count, and pollution index may affect
your eyes, these and other local weather information are shown throughout the app.


Do I have to use the TrueTear™ mobile app in order to use my TrueTear™ device?
No. The TrueTear™ mobile app is not required in order to use your TrueTear™ device.


How much does the TrueTear™ mobile app cost, and does it work on both iOS™
and Android®?
The TrueTear™ mobile app is a free app that is currently available for iOS only. We are working
on one for Android.


How do I pair and sync my TrueTear™ device and App?
Make sure Bluetooth® is enabled on your mobile device. Once you have created an account, the app
will walk you through the pairing process. Enter the serial number located on the back of the base unit,
into the app. Hold down the “-” button on the base unit for 3 seconds until a blue LED indicator flashes,
then tap the “Pair Now” button in the app.
To sync after use: with your mobile device nearby, simply use the TrueTear™ device as usual or place
the base unit into the charger. During these times the TrueTear™ device will automatically connect with
your paired mobile device.


Can I pair my TrueTear™ device with more than one mobile device?
Yes. You can pair your TrueTear™ device with multiple mobile devices; however, your device can only
be actively paired with one mobile device at any given time.


Why are all of the icons greyed out?
To protect your device data, most of the features within the app such as pairing a device require you to
have an account and an active internet connection. Make sure you’re signed in to your account and are
either connected to a Wi-Fi network or have good cell service.


What do the trend charts do?
Trend charts in the TrueTear™ mobile app summarize your use over the last two weeks by time of day
and day of the week. You can use these charts yourself or share them with your healthcare provider to
get feedback on your prescribed usage.
Please see Indication and Important Safety Information on page 6.


FREQUENTLY ASKED QUESTIONS
6 TRU105777_V3 08/ 1 7
TRUETEAR™ CONSUMER INDICATION AND
IMPORTANT SAFETY INFORMATION
INDICATION
TrueTear™ provides a temporary increase in tear production during neurostimulation in adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not use TrueTear™ if you have a cardiac pacemaker, implanted or wearable defibrillator, or other
implanted metallic or electronic device (eg, cochlear implant) in the head or neck, chronic or recurrent
nosebleeds, a bleeding disorder (eg, hemophilia), a condition that can lead to increased bleeding, or a
known hypersensitivity (allergy) to the hydrogel material.
WARNINGS
Do not use TrueTear™ around electronic monitoring equipment (eg, heart monitors or electrocardiogram
alarms), in the bath/shower, while driving, operating machinery, or during activity in which sneezing/
watery eyes may cause risk, areas other than the nose, within 3 feet of shortwave or microwave therapy
equipment, around flammable anesthetic mixture (air, oxygen or nitrous oxide). Do not continue using
TrueTear™ if your nose is irritated. Safety/effectiveness not established for longer than 6 months or for
treating aqueous-deficient dry eye disease. Safety not established in pregnancy, patients under 22 years
of age, patients with nasal or sinus surgery (including nasal cautery) or significant trauma, severe nasal
airway obstruction or vascularized polyp; active, severe systemic or chronic seasonal allergies; rhinitis or
sinusitis requiring treatment; untreated nasal infection; and disabling arthritis, neuropathy, severe
dexterity impairment or limited motor coordination.


PRECAUTIONS
Consult your doctor on TrueTear™ instructions before use and on discontinuing use if pain, discomfort or
numbness in the nose persists after reducing for higher levels/longer sessions. Remove studs, nose
rings, or other nose jewelry before use. Do not use prescription eye medications or nasal sprays 30
minutes before or after using TrueTear™. Consult your doctor before use if you have suspected or
diagnosed heart disease. Keep away from children.


ADVERSE EVENTS
Nasal pain, discomfort or burning; short-term electrical discomfort; nosebleed; nasal congestion;
headaches; trace blood in nostril; facial pain; sore eye; sinus pain; pain around the eye; runny nose;
nasal ulcers; and light-headedness.
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full
Directions for Use, please visit www.allergan.com/truetear/usa.htm or call 1-800-678- 1605. Please call
1-800-433-8871 to report an adverse event.


© 2017 ALLER GAN . ALL R I G H T S R ESERV ED. T RUE T E AR™ AND I T S D ESIGN AR E T R ADEMAR KS OF
OCULE V E, IN C . , AN ALLER G AN AFFILI A T E .

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