September 2018

COVER FEATURE

Neurostimulation device helps patients produce
their own tears


by Vanessa Caceres EyeWorld Contributing Writer


Patient using TrueTear
Source: William Faulkner, MD

 

Dry eye specialists adjust to the addition of TrueTear to their treatment toolbox

Dry eye patients can have trouble finding treatments that alleviate their signs and symptoms. TrueTear (Allergan, Dublin, Ireland), which received marketing authorization from the U.S. Food and Drug Administration in April of last year, offers a unique option to help this patient group.
Ophthalmologists are getting a handle on which patients are best suited for TrueTear, how to explain it, and how often they should use the device.

How it works

The TrueTear device provides low level neurostimulation via the nose. This sends an afferent signal via the ethmoidal branch of the ophthalmic division of cranial nerve V to the brain, said William Faulkner, MD, director, Scott E. Burk Urgent Eye Clinic, Cincinnati Eye Institute, and voluntary assistant clinical professor, Department of Ophthalmology, University of Cincinnati. An efferent signal via cranial nerve VII results in stimulation of the lacrimal glands. “The result is the production of physiologic tears with the delicate normal balance of lipid, aqueous, and mucous components,” he said.
This is all done by inserting the device in the nose for up to 3 minutes at a time. The user can adjust the low level voltage from 1 to 5. Instructions from the manufacturer recommend starting at 2.
The concept of neurostimulation may be a new one for dry eye, but it’s not new in medicine, Dr. Faulkner said. Neurostimulation has been used for decades with chronic pain, post-herpetic neuralgia, complex migraines, peripheral vascular disease, obstructive sleep apnea, and other conditions, he said.
John Sheppard, MD, president, Virginia Eye Consultants, Norfolk, Virginia, thinks that TrueTear will appeal the most to those who want a natural, homeopathic alternative. At the same time, they can use it synergistically as they continue other dry eye treatments, including artificial tears, punctal plugs, nutritionals, lid hygiene, thermal pulsation, and prescription medications.
Patients who don’t want to use drops or who have trouble administering drops—such as those with arthritis in the neck or hands—are potential candidates for TrueTear, Dr. Sheppard said. Patients with post-surgical corneal nerve injury, neurotrophic viral disease, or toxic exposure to preservatives may also lean on TrueTear for help, he added.
Stephen Pflugfelder, MD, Baylor College of Medicine, Houston, sees TrueTear as ideal for dry eye patients with episodic pain, particularly office workers who may find their eyes get more irritated as the day goes on. “It also can be for people traveling a lot or going into dry environments. It’s good for any aqueous tear patient who has the capability of responding to it,” he said.
The device is not suited for patients with a cardiac pacemaker, a defibrillator, or another metal device in the head and neck, according to device instructions.1 It is also contraindicated in those with chronic nosebleeds or a bleeding disorder.

Is it effective?

Before it entered the market, TrueTear efficacy was proven with two studies that showed how it increased tear production as measured by Schirmer score compared with a control group.2 Patient tear production was tracked for up to 180 days. There were only mild adverse events.
A randomized, double-masked, placebo-controlled study that Dr. Pflugfelder helped lead found that the device helped to stimulate degranulation of goblet cells in the conjunctiva among 15 subjects.3
In an unpublished study, Dr. Faulkner found that 71% of 28 patients with moderate to severe dry eye had a favorable impression of TrueTear and rated it 6.92 on a scale of 1 to 10. Among the 28 patients, 25% bought the device immediately; everyone in the study said they would consider purchasing it later. The patients in his study were not satisfied with their current dry eye treatments; 18% of the patients had been diagnosed with Sjögren’s syndrome.
“Patient acceptance has been generally good for the moderate to severe patients who have tried multiple other treatments and who are interested in a drug-free, drop-free option,” Dr. Faulkner said.
Dr. Sheppard and colleagues performed a double sham, single-day masked study of TrueTear neurostimulation compared to nasal prongs alone without current and to current applied extranasally. TrueTear produced significant increases in Schirmer tear secretion, while the two shams showed insignificant tear production changes.
“Our study validates the mechanism of action and highly specific nature of targeted trigeminal nerve stimulation,” he said.

Frequency of use

Instructions for TrueTear show that it can be used up to 10 times a day for up to 30 minutes total. However, it is often used less frequently.
“In clinical trials, patients used the device an average of 130 seconds a day over 6 months, averaging two to three times a day,” Dr. Faulkner said. “Frequency of use diminished over time as symptoms improved.”
Actual usage tends to vary based on the extent of dry eye that a patient has, said Richard Lewis, MD, Sacramento, California. The device’s versatility in terms of usage and voltage is something that Dr. Sheppard views as positive. “It’s adaptable and applicable to idiosyncratic needs,” Dr. Sheppard said. “The patient controls the duration, frequency, and dose.”

Insurance, pricing concerns

Although TrueTear offers a new potential treatment option, it is currently under a cash-pay model. “The launch has been hampered by poor insurance coverage and high access fees,” Dr. Lewis said. “The cash price is quite high, and there are no ‘samples’ for patients to learn to use and appreciate the device. All of this has made adoption slow.”
In his small study, Dr. Faulkner found that a number of patients wanted to wait to see if the device would eventually be covered by insurance; if it is, they would consider using it regularly.
At Dr. Sheppard’s office, some patients do not want to buy anything that is not covered by insurance. Nevertheless, he still has found an opportunity for many with TrueTear. “I think with education and knowledge, neurostimulation can solve a number of clinical and compliance problems, especially realizing that a large number of promised medications and lid procedures will actually never be employed. Observations now confirm that there is a lower utilization of over-the-counter tears once TrueTear therapy is established. Furthermore, this is the first truly patient-controlled dry eye therapy, where the patient chooses dose, frequency, and duration based on their own response and their own daily variability. With such versatility, economy, and control, there may be tremendous cost savings for patients,” he explained.

Pearls to explain TrueTear

Prescribing a device that patients have to put in their nose instead of using eye drops takes some extra chair time. There are several pearls to make patient education easier. “Once you get over the novelty of putting something in the nose, it makes a lot of sense,” Dr. Sheppard said.
1. Use the available information from the manufacturer. On the TrueTear website, there is a patient guide and a video, both of which physicians said are helpful and useful to share with patients. “[The video] saves substantial chair time as well as being an excellent introduction to the device and directions on its use,” Dr. Faulkner said.
2. Have a device available to use in your office. Patients can spend time with someone on your staff who can demonstrate it and let patients try it out, Dr. Pflugfelder said. This helps to eliminate some of the hesitation about TrueTear and gives patients a chance to see if it works well for them. “The majority of patients are OK with it if it gets their eyes moist,” Dr. Pflugfelder said. Dr. Faulkner’s study found that intranasal placement did not seem to be a significant negative factor in selecting whether to use the device or not.
3. Discuss cost savings. If you think the device would help many of your patients, have someone who will help patients analyze the costs of the device versus the cost of other dry eye treatments and medications they use. This can help them see if there is a long-term cost savings, Dr. Sheppard said.
4. Place device use in context. Dr. Sheppard and his staff still discuss other dry eye lifestyle and diet modifications, including the consumption of essential fatty acids and environmental optimization.

References

1. Instructions for use. www.truetear.com
2. Allergan Announces Positive Pivotal Trial Results for Oculeve Intranasal Tear Neurostimulator. May 16, 2016. www.allergan.com/news/news/thomson-reuters/allergan-announces-positive-pivotal-trial-results.
3. Gumus K, et al. Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on conjunctival goblet cell degranulation. Am J Ophthalmol. 2017;177:159–168.

Editors’ note: Dr. Lewis has financial interests with Aerie Pharmaceuticals (Irvine, California), Allergan, and Alcon (Fort Worth, Texas). Dr. Pflugfelder has financial interests with Allergan and Bausch + Lomb (Bridgewater, New Jersey). Dr. Sheppard has financial interests with Alcon, Allergan, and Bausch + Lomb. Dr. Faulkner has no financial interests related to his comments.

Contact information

Faulkner
: wfaulkner@cincinnatieye.com
Lewis: rlewiseyemd@yahoo.com
Pflugfelder: stevenp@bcm.edu
Sheppard: docshep@hotmail.com

Neurostimulation device helps patients produce their own tears Neurostimulation device helps patients produce their own tears
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