December 2019

CORNEA

Device Focus
Where does TrueTear fit in dry eye options?


By Rich Daly EyeWorld Contributing Writer


TrueTear
Source: William J. Faulkner, MD

 

As the dry eye device market becomes increasingly crowded, some surgeons are finding areas where one device is especially effective.
The nasal nerve stimulator TrueTear (Allergan) is a more expensive dry eye treatment than artificial tears, Stephen Pflugfelder, MD, said, but “because the patients are stimulating their own tears, it could be a mainstay in therapy with patients who are willing to use it.”
Patients Dr. Pflugfelder finds the device serves well include:
• Patients who read often and whose eyes get dry toward the end of the day
• Patients comfortable using it
• Patients who fly often
“That’s been my most frequent usage,” Dr. Pflugfelder said of frequent fliers. “But there’s no reason why it couldn’t be used daily as a substitute for artificial tears.”
William J. Faulkner, MD, has used TrueTear as a secondary or tertiary choice.
Meibomian gland dysfunction (MGD) “is rampant and should be addressed in all dry eye patients,” Dr. Faulkner said. “Additionally, immunomodulators and even steroids would be trialed first.”
He said a developmental drug using nasal spray to achieve the same goals as TrueTear may be a “game changer.”
John Sheppard, MD, has found moving TrueTear up the treatment algorithm can be very helpful in severe dry eye patients referred to him.
“I tend to get sicker patients who have been through a lot of things,” Dr. Sheppard said. “If I am referred a new dry eye patient who is taking nothing but tears, it’s very unlikely the patient will be immediately started on TrueTear.”
Other patients served well by TrueTear, according to Dr. Sheppard, include:
• Patient subgroups frustrated by traditional treatments
• Patients with very abnormal corneal nerves as shown by confocal microscopy
• Patients with traumatically based nerve injury
“In patients where I think there is a neurogenic component, TrueTear moves way up the algorithm, right behind the basic tear replacement, nutrition, and anti-inflammatory medication,” Dr. Sheppard said. “I’ve had great success with TrueTear in patients for whom anti-inflammatories have failed.”

How it works

A neurostimulator approved by the FDA in 2017, TrueTear uses two silicone prongs placed in the nose to stimulate the anterior ethmoidal nerve, which creates a reflex arc that stimulates the nerve that causes tearing, said Dr. Pflugfelder. The tear glands react by temporarily creating normal, physiologic tears.
Tear analysis confirms equivalent concentrations of total lipids, proteins, lysozyme, and lactoferrin as compared to basal tears, Dr. Faulkner said. Patients self-administer the treatment and power is adjustable from level 1–5. Dosing usually starts at 4 times daily for 30–60 seconds and may be adjusted up or down based on response. The device may be used for up to 30 minutes per 24-hour period. And no tachyphylaxis has been demonstrated.
One study sampled and interviewed 28 patients on their initial experience with TrueTear and found overall positive results, including 71% with a favorable impression. Average rating on 1–10 scale was 6.92. Among those patients, 25% purchased the device immediately, despite a lack of insurance coverage for the device, and non-purchasers all said they would consider purchasing it later.¹
“Since that publication we have used this in a small number of patients,” said Dr. Faulkner. “I have some very loyal and appreciative patients. The main objection seems to be cost and no insurance coverage. However, treatment is easy and natural and effects are immediate.”

Outer limits of treatment

The device can be helpful in patients with Sjogren’s patients or graft-versus-host disease, Dr. Faulkner said.
“However, with very severe disease some patients perceive no positive results,” Dr. Faulkner said. “Similarly, the most severe MGD patients may not do well also.”
Dr. Sheppard warned against using the device in patients whose Schirmer’s test found no tear production.
“Those patients are few and far in between—they are desperate,” Dr. Sheppard said. “If there is complete atrophy of the goblet cells and the lacrimal apparatus, then your chance of getting a good benefit are pretty low for obvious reasons.”
TrueTear costs $650 for the device, charger, and 1 month of tips, each lasting 48 hours (15 tips are included). Subsequent tips cost $43.50 each month, according to prices provided to Dr. Faulkner.

About the doctors

Stephen Pflugfelder, MD
Professor and director
Ocular Surface Center
Department of Ophthalmology
Baylor College of Medicine
Houston

William J. Faulkner, MD
Director, Scott E. Burk
Urgent Eye Clinic
Cincinnati Eye Institute/Cincinnati Vision Partners
Assistant clinical professor
Department of Ophthalmology
University of Cincinnati
Cincinnati

John Sheppard, MD
Professor of ophthalmology, microbiology, and molecular biology
Clinical director, Thomas R. Lee Center for Ocular Pharmacology
Eastern Virginia Medical School
Norfolk, Virginia

Reference

1. Faulkner WJ, Granat S. Intranasal neurostimulation for dry eye: first impressions. Curr Tre Ophthalmol. 2019;2(1):123–125.

Relevant financial interests

Faulkner: None
Pflugfelder: Clinical trial with Baylor College of Medicine Houston
Sheppard: Allergan

Contact information

Faulkner: wfaulkner@cvphealth.com
Pflugfelder: stevenp@bcm.edu
Sheppard: jsheppard@vec2020.com

Where does TrueTear fit in dry eye options? Where does TrueTear fit in dry eye options?
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