EyeWorld Asia-Pacific December 2018 Issue
16 EWAP FEATURE September 2017 severe patients who have tried mul- tiple 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 in- creases in Schirmer tear secretion, while the two shams showed insig- nificant tear production changes. “Our study validates the mech- anism 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. Howev- er, it is often used less frequently. “In clinical trials, patients used the device an average of 130 sec- onds a day over 6 months, averag- ing 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 Lew- is, 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 idio- syncratic 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 adop- tion 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 con- sider 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 educa- tion and knowledge, neurostimula- tion can solve a number of clinical and compliance problems, espe- cially realizing that a large number of promised medications and lid procedures will actually never be employed. Observations now con- firm that there is a lower utiliza- tion 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 versa- tility, 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 informa- tion 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. Pflug- felder said. This helps to eliminate some of the hesitation about Tru- eTear 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 place- ment did not seem to be a signifi- cant 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 optimiza- tion. EWAP 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 Pharmaceuti- cals (Irvine, California), Allergan, and Alcon (Fort Worth, Texas). Dr. Pflugfelder has financial interests with Allergan and Bausch + Lomb (Bridgewater, New Jersey). Dr. Shep- pard 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 – from page 15 D ce er 2018
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