Patient Guide for the TrueTear® Intranasal Tear Neurostimulator ®
NO OTHER WARRANTY Unless modified in writing and signed by both parties, this warranty is understood to be the complete and exclusive agreement between the parties, superseding all prior agreements, oral or written, and all other communications between the parties relating to the subject matter of this agreement. No employee of Allergan or any other party is authorized to make any warranty in addition to those made in this warranty.
Patient Guide for the TrueTear® Intranasal Tear Neurostimulator Please read this entire guide. If you have any questions, discuss with your provider to make sure you understand how to use the TrueTear® Intranasal Tear Neurostimulator. The TrueTear® Intranasal Tear Neurostimulator (TrueTear® device) provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
The TrueTear® Intranasal Tear Neurostimulator Patient Guide Table of Contents Section 1: Patient Guide Glossary................................................................................................................2 Introduction..........................................................................................................4 Facts About Dry Eye Symptoms...................................................................4 Indications for Use.................................................
Glossary Adverse event Base unit Cardiac demand pacemaker or defibrillator Clinical studies Contraindications Cornea Disposable tip Dry Eye symptoms Eligibility criteria Hypersensitivity Intranasal Tear Neurostimulator (TrueTear® device) Neurostimulation Precautions Schirmer test Temporary electrical discomfort Warnings 2
An undesirable effect associated with use of a medical product. The base unit produces the neurostimulation and provides a connection to the charger. Device (cardiac demand pacemaker) placed in or in close proximity to (defibrillator) the heart to maintain cardiac rhythm. Clinical studies are conducted to evaluate the use of a drug or device. Cases where the TrueTear® device should not be used. Clear tissue located in the front of the eye covering the colored area of the eye.
Introduction This guide is intended to help you decide whether to use and how to use the TrueTear® device to provide a temporary increase in tear production and improvement in dry eye symptoms. This device provides small electrical pulses to stimulate production of your own natural tears. The electrical pulses are delivered by a disposable tip attached to the TrueTear® device that you will place in your nose for short periods of time. Your provider has determined that the TrueTear® device may work for you.
• Infection, scrape (abrasion), sore formation (ulceration) or inflammation inside the nose • Irritation or sensitivity inside the nose • Lightheadedness • Headaches • Sinus pain • Sore eye • Facial pain or pain around the eye • Increased saliva production • Sensation of teeth vibrating • Excessive runny nose • Temporary increase in symptoms associated with nasal allergies • Allergic reaction to contact materials • Potential permanent scarring of the inside of nose with prolonged use Contraindications
Contraindications, Warnings, and Precautions WARNINGS (continued) • Do not use the TrueTear® device when in the bath or shower. • Do not use the TrueTear® device while driving, operating machinery, or during any activity in which sneezing or watery eyes may put you at risk of injury. • Do not apply the TrueTear® device to the neck, chest, or areas other than the nose.
WARNINGS (continued) • D isabling arthritis, neuropathy, severe dexterity impairment or limited motor coordination that would affect your ability to use or handle the TrueTear® device • Active and severe: • Systemic allergy • Chronic seasonal allergies • Rhinitis or sinusitis requiring treatment such as antihistamines, decongestants, oral or aerosol steroids • Untreated nasal infection PRECAUTIONS Precautions provide information regarding any special care to be exercised by the provider and/or patient fo
Are You a Good Candidate for Use of the TrueTear® Intranasal Tear Neurostimulator? You are a good candidate for the TrueTear® device if you: • Are at least 22 years old. • Have dry eye symptoms. • Are able to use the TrueTear® Intranasal Tear Neurostimulator. • Do not have a cardiac demand pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device in the head or neck. • Do not have a known hypersensitivity to the any of the device materials that contact you.
Summary of Important Information • The TrueTear® device provides a temporary increase in tear production during use resulting in an improvement in dry eye symptoms in adult patients with severe dry eye symptoms.
Instructions for Use OVERVIEW OF THE TRUETEAR® DEVICE COMPONENTS The TrueTear® device consists of three parts. 1 A disposable tip, which is inserted into the nasal cavity and provides the contact surface for the stimulation in the nose 2 A base, which produces the stimulation 3 A case that protects and charges the device in between uses The disposable tip (tip) is connected to the base for stimulation. The tip provides the contact for conducting the stimulation current, which is produced by the base.
USING AND CHARGING THE DEVICE NOTE: Only use the provided AC adapter. 1 Open the case and place the base with the attached tip inside the case. the base (front) should face up. 2 Close the case. If the case is not closed, the base may not charge properly. 3 Connect the provided cable and adapter to the case and plug the adapter into an active (120-240V) outlet. 4 The case bottom will glow orange when the device is charging and glow blue when the device is fully charged.
STIMULATION INSTRUCTIONS 1 Remove a new disposable tip from the pouch. Figure 3.
3 Connect the tip to the base by aligning the post on the underside of the tip with notch on base, then rotate forward until the tip snaps into place, as shown in Figure 4. Figure 4. Align the tab to the notch for setup. The tip only fits one way.
There are 5 stimulation intensity levels. The base vibrates briefly when the + or - button is pressed to indicate an increase or decrease in stimulation level. The blue lights will be lit to indicate the stimulation level selected.
Always start on level 1. Insert tip into your nose, as far as is comfortable. Rest thumb on the + or — button. Press + or — to change levels if desired. Figure 6. Target zone for correct insertion of disposable tip. 5. The + button is for increasing the intensity and the – button is for decreasing the intensity.
6 You may reposition the tip inside the nose for desired stimulation. The feeling should be mild at its maximum intensity. 7 Remove the tip from your nose at any time if you feel uncomfortable during stimulation. 8 The device turns off automatically after three (3) minutes. You can also turn it off manually by pressing the - button for 2 seconds. The device will vibrate and the lights will turn off to indicate the device is off. Note: You can turn the device off as soon as tears start forming.
RECOMMENDED STIMULATION SCHEDULE Use the TrueTear® device at least twice a day, as needed. Stimulation longer than 3 minutes is not recommended, and you should wait for at least 60 minutes before proceeding to the next application. The device has a built-in single-day usage limit of 30 minutes. If this daily limit has been reached, the TrueTear® device will turn on and then off immediately. The device will not deliver stimulation. Replace the tip every 28 days with a new tip.
3 Do NOT place or submerge any part of the device or the case in water or other liquid. 4 Handle with care. Store the TrueTear® device in its case in a clean, cool, and dry location. Avoid exposure to extreme temperatures and humidity. CAUTION: Avoid touching the metal contacts on the tip if the device has been exposed to high temperature extremes (such as in a hot car). The expected service life for the base and case is 3 years from the date of purchase.
Bluetooth® The TrueTear® device includes Bluetooth® Smart wireless technology. This optional feature can be turned on to allow you to view your TrueTear® device data and track your usage on your smartphone via the TrueTear® mobile app. The Bluetooth® feature does not have to be on for you to use the TrueTear® device. For more information on using Bluetooth® and the TrueTear® mobile app, please visit www.truetear.com/app.
If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna • Increase the separation between the equipment and receiver • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected • Consult the dealer or an experienced radio/TV tech
of in normal waste stream Charger is protected agains 12.5 mm Ø and greater. Prot falling water drops. Symbol IEC 60601-1-2: 2014-02 Description Basic Standard Phenomenon IEC 61000-4-2 Electrostatic discharge Caution Base Unit is protected again mm Ø and greater. P falling± 8water drops when en Contact discharge: kV Test Specification of 12.
Summary of Clinical Studies Two pivotal clinical studies have been conducted with the TrueTear® device. Both studies evaluated the device’s safety and effectiveness in dry eye patients. Both pivotal studies (OCUN-009 and OCUN-010) demonstrated the device’s capability temporarily to increase tear production during stimulation. OCUN-010 also demonstrated the TrueTear® device’s capability to improve dry eye symptoms as a result of stimulation. The next section summarizes both pivotal studies.
Schirmer Scores - Study Eye 40.0 Schirmer Score (mm) 35.0 30.0 25.0 20.0 15.0 10.0 5.0 0.0 a b Sham Sham Intranasal Intranasal Extranasal Extranasal Applicationc Application Figure 10. Tear production score (Schirmer).
Eligible participants were enrolled in the study and provided with a TrueTear® device for home use. Participants were instructed to use the TrueTear® device at least two times a day and as often as 10 times per day, as needed, and no more than three minutes per use. Study participants were examined at Baseline and days 7, 30, 90, and 180. Ninety-seven (97) people with dry eye symptoms were enrolled at three sites in the U.S.
were shown to have meaningful improvement in their symptoms. There were more subjects with severe dry eye symptoms that had a meaningful improvement in symptoms from baseline as measured with the OSDI than the number with meaningful worsening of symptoms at day 7 and at day 30. Safety and effectiveness of intranasal electrical stimulation was evaluated over a 6-month period of time. The safety and effectiveness of the TrueTear® device for longer periods of use has not been established.
Warranty Information Allergan warrants to the original purchaser of the TrueTear® device that your 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.
WARRANTY CLAIM PROCEDURE You must notify Allergan of the claimed defect within the warranty period by writing or calling: Allergan, 4410 Rosewood Drive, Pleasanton, CA 94588; Telephone: 1-866-502-TEAR (8327) and Fax: 1-855-637-4959. The claim must include the date of purchase, model number, serial number, and a description of the claimed defect. Allergan’s authorization must be obtained prior to returning the TrueTear® device.
Quick Start Instructions Getting started with your TrueTear® device ® 28
Do I have everything I need? a. Base b. Case c. USB cable d. AC adapter All images shown in this guide are for referencing only. a. c. b. d.
1. Get ready. Plug case into wall outlet. Place the TrueTear® base in the case. Close the case to charge. Ensure the base is fully charged before first use. A full charge typically takes less than 4 hours. A steady orange light on the bottom of the case indicates that it is charging. The light will turn blue to indicate that charging is complete.
2. Get set. Remove a new disposable tip from the pouch. Align tab on disposable tip with notch on base, and connect. Replace the tip every 28 days with a new tip. Failure to do so will prevent the device from delivering stimulation.
3. Activate! a. Hold the + button on the base for 2 seconds to turn on the device. d. For effective stimulation, insert the tip towards the top and front of the nose. b. Use the + and – buttons to select the desired stimulation level. c. Place thumb near buttons of base, and gently insert the tip into the nose with the back of the base facing out. Ready A steady white light will appear on the base indicating that the device is on.
e. Gradually adjust the intensity (using the + and – buttons) until you feel a gentle tingling sensation in your nose. This feeling indicates you are stimulating the correct tissue location and tears will form. f. The device turns off automatically after three (3) minutes. You can also turn it off manually by pressing the - button for 2 seconds. Target location The tip may be repositioned in your nose to achieve desired stimulation. Stimulation level There are 5 stimulation levels.
4. Keep it clean. Wipe base, disposable tip, and case with an alcohol pad after use. Do not submerge or immerse the base & AC adapter in water or any other liquid. Place base in the case to protect the device until your next use. Keep device in a clean, cool, and dry location. Avoid exposure to extreme temperatures and humidity.
Please refer to your Instructions for Use for additional details or call Allergan® at 1-866-502-TEAR(8327). © 2019 Allergan. All rights reserved. TrueTear® and its design are trademarks of Oculeve, Inc., an Allergan affiliate. Allergan® and its design are trademarks of Allergan, Inc. www.allergan.
