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`Diseases and Conditions
`
`Dry eyes
`
`By Mayo Clinic Staff
`
`Dry eyes is a common condition that occurs when your tears aren't able to provide
`adequate lubrication for your eyes. Tears can be inadequate for many reasons. For
`example, dry eyes may occur if you don't produce enough tears or if you produce poor-
`quality tears.
`
`Dry eyes feel uncomfortable. If you have dry eyes, your eyes may sting or burn. You may
`experience dry eyes in certain situations, such as on an airplane, in an air-conditioned
`room, while riding a bike or after looking at a computer screen for a few hours.
`
`Treatments for dry eyes may make you more comfortable. These treatments can include
`lifestyle changes and eyedrops. You'll likely need to take these measures indefinitely to
`control the symptoms of dry eyes.
`
`Signs and symptoms, which usually affect both eyes, may include:
`
`• A stinging, burning or scratchy sensation in your eyes
`• Stringy mucus in or around your eyes
`• Sensitivity to light
`• Eye redness
`• A sensation of having something in your eyes
`• Difficulty wearing contact lenses
`• Difficulty with nighttime driving
`• Watery eyes, which is the body's response to the irritation of dry eyes
`• Blurred vision or eye fatigue
`When to see a doctor
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`http://www.mayoclinic.org/diseases-conditions/dry-eyes/basics/treatment/con-20024129?p=1
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`MYLAN - EXHIBIT 1079
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`See your doctor if you've had prolonged signs and symptoms of dry eyes, including red,
`irritated, tired or painful eyes. Your doctor can take steps to determine what's bothering
`your eyes or refer you to a specialist.
`
`Dry eyes are caused by a lack of adequate tears. Your tears are a complex mixture of
`water, fatty oils and mucus. This mixture helps make the surface of your eyes smooth
`and clear, and it helps protect your eyes from infection.
`
`For some people, the cause of dry eyes is decreased tear production. For others it's
`increased tear evaporation and an imbalance in the makeup of your tears.
`Decreased tear production
`Dry eyes can occur when you're unable to produce enough tears. The medical term for
`this condition is keratoconjunctivitis sicca(ker-uh-toe-kun-junk-tih-VY-tis SIK-uh).
`Common causes of decreased tear production include:
`
`• Aging
`• Certain medical conditions, including diabetes, rheumatoid arthritis, lupus,
`scleroderma, Sjogren's syndrome, thyroid disorders and vitamin A deficiency
`• Certain medications, including antihistamines, decongestants, hormone replacement
`therapy, antidepressants, and drugs for high blood pressure, acne, birth control and
`Parkinson's disease
`• Laser eye surgery, though symptoms of dry eyes related to this procedure are usually
`temporary
`• Tear gland damage from inflammation or radiation
`Increased tear evaporation
`Common causes of increased tear evaporation include:
`
`• Wind, smoke or dry air
`• Blinking less often, which tends to occur when you're concentrating, for example,
`while reading, driving or working at a computer
`• Eyelid problems, such as out-turning of the lids (ectropion) and in-turning of the lids
`(entropion)
`Imbalance in tear composition
`The tear film has three basic layers: oil, water and mucus. Problems with any of these
`layers can cause dry eyes. For example, the oil film produced by small glands on the
`edge of your eyelids (meibomian glands) might become clogged. Blocked meibomian
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`glands are more common in people with inflammation along the edge of their eyelids
`(blepharitis), rosacea or other skin disorders.
`
`Factors that make it more likely that you'll experience dry eyes include:
`
`• Being older than 50. Tear production tends to diminish as you get older. Dry eyes are
`common in people over 50.
`• Being a woman. A lack of tears is more common in women, especially if they
`experience hormonal changes due to pregnancy, using birth control pills or
`menopause.
`• Eating a diet that is low in vitamin A, which is found in liver, carrots and broccoli, or
`low in omega-3 fatty acids, which are found in fish, walnuts and vegetable oils
`• Wearing contact lenses
`
`People who have dry eyes may experience these complications:
`• Eye infections. Your tears protect the surface of your eyes from infection. Without
`adequate tears, you may have an increased risk of eye infection.
`• Damage to the surface of your eyes. If left untreated, severe dry eyes may lead to
`eye inflammation, abrasion of the corneal surface, corneal ulcer and vision problems.
`• Decreased quality of life. Dry eyes can make it difficult to perform everyday
`activities, such as reading.
`
`You're likely to start by seeing your family doctor. He or she may then refer you to an eye
`specialist (ophthalmologist). Because appointments can be brief, it's a good idea to be
`well-prepared for your appointment.
`What you can do
`• List any symptoms you're experiencing, including any that may seem unrelated to
`the reason for which you scheduled the appointment.
`• List key personal information, including any recent life changes.
`• Make a list of all medications, vitamins and supplements that you're taking.
`• List questions to ask your doctor.
`
`For dry eyes, some basic questions to ask your doctor include:
`
`• What's the most likely cause of my dry eyes?
`• Do I need any tests?
`• Can dry eyes get better on their own?
`• What are my treatment options?
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`• What are the potential side effects of each treatment?
`• I have other health conditions. How can I best manage these conditions together?
`• Is a generic drug available for the medicine you're prescribing me?
`• Do you have any brochures or other printed material that I can take with me?
`• What websites do you recommend?
`• Do I need to plan for a follow-up visit?
`
`Don't hesitate to ask additional questions that may occur to you during your appointment.
`What to expect from your doctor
`Your doctor may ask:
`
`• Can you describe your symptoms?
`• Do you recall when you first began experiencing symptoms?
`• Have your symptoms been continuous or occasional?
`• Do other members of your family have dry eyes?
`• Have you tried over-the-counter eyedrops? Did they provide relief?
`• Are your symptoms worse in the morning or late in the day?
`• What medications do you take?
`• Have you had any radiation to the head or neck?
`What you can do in the meantime
`To relieve your signs and symptoms while you wait for your appointment, try over-the-
`counter eyedrops. Look for lubricating eyedrops (artificial tears) and avoid those that
`advocate reducing redness in the eyes. Eyedrops that reduce eye redness can cause
`additional eye irritation.
`
`Tests and procedures that may be used to determine the cause of your dry eyes include:
`• A comprehensive eye exam. An eye exam that includes a complete history of your
`overall health and your eye health can help your doctor diagnose the cause of your
`dry eyes.
`• Measuring the volume of your tears. Your doctor may measure your tear
`production using the Schirmer test. In this test, blotting strips of paper are placed
`under your lower eyelids. After five minutes your doctor measures the amount of strip
`soaked by your tears.
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`http://www.mayoclinic.org/diseases-conditions/dry-eyes/basics/treatment/con-20024129?p=1
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`• Determining the quality of your tears. Other tests use special dyes in eyedrops to
`determine the surface condition of your eyes. Your doctor looks for staining patterns
`on the corneas and measures how long it takes before your tears evaporate.
`
`For most people with occasional or mild dry eye symptoms, it's enough to regularly use
`over-the-counter eyedrops (artificial tears). If your symptoms are persistent and more
`serious, you have other options. What you do depends on what's causing your dry eyes.
`
`Some treatments focus on reversing or managing a condition or factor that's causing
`your dry eyes. Other treatments can improve your tear quality or stop your tears from
`quickly draining away from your eyes.
`Treating the underlying cause of dry eyes
`In some cases, treating an underlying health issue can help clear up the signs and
`symptoms of dry eyes. For instance, if a medication is causing your dry eyes, your doctor
`may recommend a different medication that doesn't cause that side effect. If you have an
`eyelid condition, such as out-turning lids (ectropion), your doctor may refer you to an eye
`surgeon who specializes in plastic surgery of the eyelids (oculoplastic surgeon). Or if you
`have rheumatoid arthritis, your doctor may refer you to a rheumatologist.
`Medications
`Prescription medications used to treat dry eyes include:
`• Drugs to reduce eyelid inflammation. Inflammation along the edge of your eyelids
`can keep oil glands from secreting oil into your tears. Your doctor may recommend
`antibiotics to reduce inflammation. Antibiotics for dry eyes are usually taken by mouth,
`though some are used as eyedrops or ointments.
`• Eyedrops to control cornea inflammation. Inflammation on the surface of your
`eyes (cornea) may be controlled with prescription eyedrops that contain the immune-
`suppressing medication cyclosporine (Restasis) or corticosteroids. Corticosteroids are
`not ideal for long-term use due to possible side effects.
`• Eye inserts that work like artificial tears. If you have moderate to severe dry eye
`symptoms and artificial tears don't help, another option may be a tiny eye insert that
`looks like a clear grain of rice. Once a day, you place the hydroxypropyl cellulose
`(Lacrisert) insert between your lower eyelid and your eyeball. The insert dissolves
`slowly, releasing a substance that's used in eyedrops to lubricate your eye.
`• Tear-stimulating drugs. Drugs called cholinergics (pilocarpine, cevimeline) help
`increase tear production. These drugs are available as pills, gel or eyedrops. Possible
`side effects include sweating.
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`• Eyedrops made from your own blood. These are called autologous blood serum
`drops. They may be an option if you have severe dry eye symptoms that don't
`respond to any other treatment. To make these eyedrops, a sample of your blood is
`processed to remove the red blood cells and then mixed with a salt solution.
`Other procedures
`Other procedures that may be used to treat dry eyes include:
`• Closing your tear ducts to reduce tear loss. Your doctor may suggest this
`treatment to keep your tears from leaving your eye too quickly. This can be done by
`partially or completely closing your tear ducts, which normally serve to drain tears
`away.
`
`Tear ducts can be plugged with tiny silicone plugs (punctal plugs). These are
`removable. Or tear ducts can be plugged with a procedure that uses heat. This is a
`more permanent solution called thermal cautery.
`• Using special contact lenses. Ask your doctor about newer contact lenses designed
`to help people with dry eyes.
`
`Some people with severe dry eyes may opt for special contact lenses that protect the
`surface of your eyes and trap moisture. These are called scleral lenses or bandage
`lenses.
`• Unblocking oil glands. Dry eyes caused by blocked oil glands may be helped by a
`treatment called LipiFlow thermal pulsation. During the treatment, a device that looks
`like an eyecup is placed over your eye. It delivers a gentle, warm massage to the
`lower eyelid. The procedure takes less than 15 minutes. It's not clear whether this
`method is better at clearing blocked oil glands than regular warm compresses and
`eyelid washing.
`• Using light therapy and eyelid massage. A technique called intense-pulsed light
`therapy followed by massage of the eyelids helps people with severe dry eyes. In one
`study, the therapy was given monthly to 78 people, and 68 of them experienced
`reduced symptoms.
`
`You may be able to manage your dry eyes with frequent eyelid washing and use of over-
`the-counter (OTC) eyedrops or other products that help lubricate your eyes. If your
`condition is long term (chronic), use eyedrops even when your eyes feel fine to keep
`them well-lubricated.
`Selecting and using OTC products for dry eyes
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`http://www.mayoclinic.org/diseases-conditions/dry-eyes/basics/treatment/con-20024129?p=1
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`A variety of nonprescription products for dry eyes are available, including eyedrops
`(artificial tears), gels, gel inserts and ointments. Talk with your doctor about which might
`be best for you.
`
`Artificial tears may be all you need to control mild dry eye symptoms. Some people need
`to put drops in several times a day, and some use them only once a day.
`
`Consider these factors when selecting an OTC product:
`• Preservative vs. nonpreservative drops. Preservatives are added to some
`eyedrops to prolong shelf life. You can use eyedrops with preservatives up to four
`times a day. But using the preservative drops more often can cause eye irritation.
`Nonpreservative eyedrops come in packages that contain multiple single-use vials.
`After you use a vial, you throw it away. If you rely on eyedrops more than four times a
`day, nonpreservative drops are safe.
`• Drops vs. ointments. Lubricating eye ointments coat your eyes, providing longer
`lasting relief from dry eyes. But these products are thicker than eyedrops and can
`cloud your vision. For this reason, ointments are best used just before bedtime.
`Eyedrops can be used at any time and won't interfere with your vision.
`• Drops that reduce redness. It's best to avoid these as your solution for dry eyes, as
`prolonged use can cause irritation.
`Washing your eyelids to control inflammation
`For people with blepharitis and other conditions that cause eyelid inflammation that
`blocks the flow of oil to the eye, frequent and gentle eyelid washing may help. To wash
`your eyelids:
`• Apply a warm washcloth to your eyes. Wet a clean cloth with warm water. Hold the
`cloth over your eyes for five minutes. Rewet the cloth with warm water when it cools.
`Gently rub the washcloth over your eyelids — including the base of the eyelashes —
`to loosen any debris.
`• Use a mild soap on your eyelids. Use baby shampoo or another mild soap. Put the
`cleanser on your clean fingertips and gently massage your closed eyes near the base
`of your eyelashes. Rinse completely.
`
`Your doctor may recommend that you do this daily, even when your dry eye symptoms
`have been relieved. Stopping this daily routine may allow your symptoms to return.
`
`Further study is needed, but some alternative medicine approaches may help relieve
`your dry eye symptoms. Discuss the benefits and risks with your doctor.
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`http://www.mayoclinic.org/diseases-conditions/dry-eyes/basics/treatment/con-20024129?p=1
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`• Fatty acids. Adding omega-3 and omega-6 fatty acids to your diet may help relieve
`dry eye signs and symptoms. These are available as supplements and in foods such
`as flaxseed, salmon, sardines and vegetable oils.
`• Castor oil eyedrops. These eyedrops may improve symptoms by reducing tear
`evaporation.
`• Acupuncture. Some people have seen their dry eye symptoms improve after
`acupuncture therapy.
`
`If you experience dry eyes, pay attention to the situations that are most likely to cause
`your symptoms. Then find ways to avoid those situations in order to prevent your dry
`eyes symptoms. For instance:
`• Avoid air blowing in your eyes. Don't direct hair dryers, car heaters, air conditioners
`or fans toward your eyes.
`• Add moisture to the air. In winter, a humidifier can add moisture to dry indoor air.
`• Consider wearing wraparound sunglasses or other protective eyewear. Safety
`shields can be added to the tops and sides of eyeglasses to block wind and dry air.
`Ask about shields where you buy your eyeglasses.
`• Take eye breaks during long tasks. If you're reading or doing another task that
`requires visual concentration, take periodic eye breaks. Close your eyes for a few
`minutes. Or blink repeatedly for a few seconds to help spread your tears evenly over
`your eyes.
`• Be aware of your environment. The air at high altitudes, in desert areas and in
`airplanes can be extremely dry. When spending time in such an environment, it may
`be helpful to frequently close your eyes for a few minutes at a time to minimize
`evaporation of your tears.
`• Position your computer screen below eye level. If your computer screen is above
`eye level, you'll open your eyes wider to view the screen. Position your computer
`screen below eye level so that you won't open your eyes as wide. This may help slow
`the evaporation of your tears between eye blinks.
`• Stop smoking and avoid smoke. If you smoke, ask your doctor for help devising a
`quit-smoking strategy that's most likely to work for you. If you don't smoke, stay away
`from people who do. Smoke can worsen dry eyes symptoms.
`• Use artificial tears regularly. If you have chronic dry eyes, use eyedrops even when
`your eyes feel fine to keep them well-lubricated.
`References
`
`1. AskMayoExpert. Dry eye disease. Rochester, Minn.: Mayo Foundation for Medical Education and
`Research; 2014.
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`2. Dry eye. American Optometric Association. http://www.aoa.org/patients-and-public/eye-and-vision-
`problems/glossary-of-eye-and-vision-conditions/dry-eye?sso=y. Accessed June 2, 2015.
`
`3. What is dry eye? American Academy of Ophthalmology. www.geteyesmart.org/eyesmart/diseases/dry-
`eye/index.cfm. Accessed June 2, 2015.
`
`4. Yao W, et al. Dry eye syndrome: An update in office management. The American Journal of Medicine.
`2011;124:1016.
`
`5. Stevenson W, et al. Dry eye disease. Archives of Ophthalmology. 2012;130:90.
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`6. Shtein RM. Dry eyes. www.uptodate.com/home. Accessed June 2, 2015.
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`7. Dry eye syndrome Summary Benchmark — 2014. American Academy of Ophthalmology.
`http://www.aao.org/summary-benchmark-detail/dry-eye-syndrome-summary-benchmark--october-2012.
`Accessed June 2, 2015.
`
`8. Rand AL, et al. Nutritional supplements for dry eye syndrome. Current Opinion in Ophthalmology.
`2011;22:279.
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`9. Facts about dry eye. National Eye Institute. http://www.nei.nih.gov/health/dryeye/dryeye.asp. Accessed
`June 2, 2015.
`
`10. Yanoff M, et al., eds. Dry eye. In: Ophthalmology. 4th ed. Edinburgh, U.K.: Mosby Elsevier; 2014.
`https://www.clinicalkey.com. Accessed June 2, 2015.
`
`11. Skalicky SE, et al. New agents for treating dry eye syndrome. Current Allergy and Asthma Reports.
`2013;13:322.
`
`12. Toyos R, et al. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction: A
`3-year retrospective study. Photomedicine and Laser Surgery. 2015;33:41.
`
`13. Marcet MM, et al. Safety and efficacy of lacrimal drainage system plugs for dry eye syndrome.
`Ophthalmology. In press. Accessed June 2, 2015.
`
`14. Eye disorders. Natural Standard. https://naturalmedicines.therapeuticresearch.com. Accessed June 2,
`2015.
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`15. Castor bean. Natural Medicines Comprehensive Database. http://naturaldatabase.therapeuticresearch.com.
`Accessed June 2, 2015.
`
`16. Rocha EM, et al. Hormones and dry eye syndrome: An update on what we do and don't know. Current
`Opinion in Ophthalmology. 2013;24:348.
`
`17. Omega-3 fatty acid. Natural Medicines Comprehensive Database.
`http://naturaldatabase.therapeuticresearch.com. Accessed June 3, 2015.
`
`18. Vitamin A. Natural Medicines Comprehensive Database. http://naturaldatabase.therapeuticresearch.com.
`Accessed June 3, 2015.
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`19. Finis D, et al. Evaluation of an automated thermodynamic treatment (LipiFlow) system for meibomian gland
`dysfunction: A prospective, randomized, observer-masked trial. Ocular Surface. 2014;2:146.
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`20. Robertson DM (expert opinion). Mayo Clinic, Rochester, Minn. June, 12, 2015.
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`21. Zouboulis CC, et al., eds. A treatment strategy for rosacea. In: Pathogenesis and Treatment of Acne and
`Rosacea. Berlin Heidelberg: Springer-Verlag, 2014.
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`22. Preferred practice pattern: Dry eye syndrome. San Francisco, Calif.: American Academy of Ophthalmology.
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`464b9d15b748. Accessed June 14, 2012.
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`July 24, 2015
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`Original article: http://www.mayoclinic.org/diseases-conditions/dry-eyes/basics/treatment/con-20024129
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