What is TrueTear®

TrueTear® is the first of its kind in eye care. TrueTear® provides a temporary increase in tear production during neurostimulation in adult patients.
 

The neurostimulation approach with TrueTear™ is a proven technology that is used in well know devices like pacemakers, cochlear implants and TENS Devices for chronic back pain. TrueTear™ is the first and only neurostimulation device for the treatment of Dry Eye Disease and is FDA approved to safely stimulate the nerves that supply the Lacrimal Function Unit (LFU); which is the part of your eyes that supplies the natural, healthy tears that keeps our eyes moist, comfortable and clear.  The LFU is very complex, with multiple components and parts that can become damaged and breakdown in the Dry Eye Disease cycle. Past Dry Eye treatments usually focus on helping one or a few of the damaged parts only, but TrueTear™ has the ability to help the entire LFU naturally. It does this in a drug free way that basically turns your eyes natural tear system back on.

With TrueTear®, tearing can occur within seconds, however it can take a shorter or longer time depending on the patient. The effect is temporary, but patients can use TrueTear® at least twice a day, as needed. The device may be used for up to 30 minutes per 24 hour period. It can fit right into patient’s daily routine.

Why TrueTear®?


• Drug-free, drop-free option for temporarily producing more of your own tears
• Uses state-of-the-art neurostimulation technology
• Tip emits tiny pulses of energy to stimulate a nerve inside the nasal cavity, and the tear glands respond 

Benefits 


• The tear glands react by temporarily making more of your own natural tears that include proteins and lipids
• Neurostimulation has been used for decades (use TENS therapy as an example)
• TrueTear® works: patients in the clinical study saw 2.5 x increase in tear production 
• Use TrueTear® at least twice a day, as needed. The device may be used for up to 30 minutes per 24 hour period
• Tips are disposable and easy to order
• Unit comes with a cover, so it’s safe to take it with you and use discreetly
• Mild side effects
• Good candidates for TrueTear® are at least 22 years old and have dry eye from inadequate tear product

TrueTear® Instructional Video
Frequently Asked Questions

Do I need a prescription to use the device?

Yes. You need a prescription from your eye care professional to use 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 my device?

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. For all warranty terms and conditions, please see the Instructions for Use that accompanied your TrueTear® device or truetear.com.

How far do I need to insert the tips 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 TrueTear® is working?

You have the tip in 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 intensity level do I have to use to tear?

Each 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 a clinical trial.

Does it matter if I use the device for 30 seconds or 3 minutes?

Use of the device can vary depending on the individual patient. Use until you see/feel tears coat the surface of your eye. Using the device longer than 3 minutes is not recommended, and the patient should wait for at least 60 minutes before inserting into the nose again.

How often and how long do I need to use the device?

The device is capable of single-day use up to a limit of 30 minutes. Use longer than 3 minutes per session is not recommended, and the patient should wait for at least 60 minutes before inserting into the nose 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 when 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 when changing the tip.

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 use each time. To use longer than 1 minute, simply start another cycle, although using the device longer than 3 minutes per session is not recommended, and the patient should wait for at least 60 minutes before using again.

Will I experience nasal pain when 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 doctor.

Is it possible to feel an electrical shock in my nose when the TrueTear® tips are 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 doctor.

 

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.

How long can I use one tip?

The tip should be replaced every two days or every 48 hours. The tip contains a hydrogel that wears down after two days of use. Once the hydrogel is dried out, the tip will no longer work. 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 disposable tip, being careful not to rub the hydrogel areas.

How do I clean my base unit, charger, and carry 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 if needed to ensure proper hygiene. 

 

Are the tips 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 tips away in a regular trashcan?

Yes. The TrueTear® diposable tip can go in the regular trash for disposal.

Contraindications
Contraindications are situations where it is advisable not to use the TrueTear™ device. If you have any of the following, you shouldNOT use this device:


• A cardiac (for your heart) pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic  device (eg, cochlear implant) in the head or neck
• Chronic or frequent nosebleeds, a bleeding disorder (eg, hemophilia), or another condition that can lead to
increased bleeding
• A known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of your nose

For more information visit: www.truetear.com or contact your provider at (910) 484-2284.