WOMEN AND DRY

Shining a on This Essential Dry Segment

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101516_akorn__rp_jA.indd 1 9/22/16 1:41 PM WOMEN AND Marguerite McDonald, MD, FACS (Moderator) DRY EYE NYU School of Medicine, Ophthalmic Consultants of Long Island New York, New York Shining a Light on This Essential Dry Eye Disease Segment

esearch in recent years has found that as many Etty Bitton, OD, MSc, FAAO Ras 78.5 million Americans may suffer from dry eye Université de Montréal disease (DED), with nearly twice the number of Montreal, Quebec, Canada females ages 50 years or older reportedly suffering from the disease than males in the same age bracket.1,2,3 In the clinical realm, not only do women report DED symptoms with a higher frequency, but they also cite the severity and impact on their daily lives to be great- er. A 2013 study found that women spent signifi cantly more money per month on dry eye therapies, and Whitney Hauser, OD expressed greater dissatisfaction with treatment side Signal Ophthalmic Consulting effects and time to amelioration than their male coun- Memphis, Tennessee terparts.4 As the “healthcare gatekeepers” for their families (as described by one group of researchers), women’s personal satisfaction with available ocular care services is mission critical.5 If not promptly diagnosed, DED and its systematic Paul M. Karpecki, OD, FAAO effects on female patients’ ocular and vision health is Kentucky Eye Institute, further amplifi ed. According to the Mayo Clinic, dry eye Lexington, Kentucky complications include greater risk of eye infection and Gaddie Eye Centers, Louisville, ocular surface damage, which can lead to infl ammation, Kentucky corneal surface abrasion and ulcers, and vision prob- lems if left unaddressed.6 Beyond the physical consequences of DED is the re- sulting degradation in life quality, reported to be acutely experienced by female patients due to the inability of these patients to perform many everyday activities.6 Terrence P. O’Brien, MD This in turn heightens the risk of psychosomatic disor- Bascom Palmer Eye Institute ders, such as depression, stress and anxiety.7,8 In se- Palm Beach Gardens, Florida vere DED cases, patient utility assessment scores are, somewhat shockingly, comparable to those of acute angina and dialysis patients.9,10 This diverse panel of luminaries sheds light on the truth about today’s experience for female dry eye disease patients, and provides recommendations for diagnosing, treating and managing this unique—and essential—segment of DED sufferers.

– Marguerite McDonald, MD, FACS

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101516_akorn__rp_jA.indd 2 9/22/16 1:41 PM The Face of Dry Eye What Are the Symptoms of Dry Eye? Disease Dry eye symptoms may include any of the following: Dr. McDonald: Are the dry eye • Stinging or burning of the eye disease statistics cited earlier • A sandy or gritty feeling as if something is in the eye estimating nearly double the • Episodes of excess following very dry eye periods number of women than men, • A stringy discharge from the eye representative of what you are • and redness of the eye 2,3 seeing in your practice? • Episodes of Dr. Karpecki: This does rep- • Heavy resent the majority of patients • Inability to cry when emotionally stressed that I see. In fact, the ratio is • Discomfort with contact lenses at least 2:1 women to men in • Decreased tolerance for reading, working on the computer or any activity that patients over age 50—or, age requires sustained visual attention 44, in my estimate. I’m also • Eye fatigue noticing a clear hormonal component with DED since the National Eye Institute. What are the symptoms of dry eye? Available at: https://nei.nih.gov/health/dryeye/dryeye (last preponderance of these patients accessed May 1, 2016). are perimenopausal. If you look at the 2014 Beaver Dam understand that dry eye and maintain the integrity of the Offspring Study as evidence, ocular surface diseases tend to ocular surface. This includes the incidence of dry eye in the be progressive. In fact, many the —the fi rst interface patient population under age eye care providers have begun for clear vision as well as the 40 was relatively equal between to view these diseases with an . When the cornea men and women.11 approach similar to .12 is not kept adequately lubri- Dr. Bitton: We, too, fi nd this Severe DED cases can lead cated it will progress to severe to be the core demographic of to irreversible ocular surface dryness, which will eventually dry patients—especially damage when not under proper deteriorate vision. Even tran- post-menopausal women. management, and similar to sient blur throughout the day Dr. O’Brien: The data high- glaucoma, dry eye disease can can impact daily activities, in- lighted are also consistent with permanently impair goblet cells, cluding computer use, reading, my experiences in clinical prac- limbal stem cell and lacrimal driving, etc. Keeping the tear tice, where women are nearly glands, potentially impacting a fi lm stable and uniform using two times as likely to have dry patient’s visual function if left a product such as TheraTears® eye disease as men. unaddressed. Dry Eye Therapy Lubricant Dr. Hauser: Agreed. DED is a Eye Drops will provide a clear Consequences of chronic, progressive condition. refractive surface, and lubricate Neglecting Dry Eye Just like any other disease that the corneal surface for unwav- Dr. McDonald: Can you talk goes unmanaged, the associated ering vision throughout the day. about the systemic impacts of —such as leaving dry eye disease untreat- fl uctuating vision, redness and Symptom Presentation ed and how this can negatively irritation—only worsen with in the Female Patient impact on a woman’s ocular time. Dr. McDonald: Do men and health and overall well-being? Dr. Bitton: The tear fi lm has women with dry eye typically Dr. O’Brien: We have come to many roles, one of which is to present with different symp- toms/complaints? Dr. Karpecki: In my experi- ence, women are more likely to seek clinical help at an earlier stage of DED; thus, symptoms such as transient blur, burning, dryness and irritation are more common. Men tend to wait until advanced stages to come to my offi ce, and then frequent- Patient reports fl uctuating vision at the end of the day, chronic redness and transient ly complain of blurred vision, irritation. Photos: Whitney Hauser, OD which, upon investigation, has

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101516_akorn__rp_jA.indd 3 9/22/16 1:41 PM Expert DED Management Protocol: Dry Eye Summit The 2014 Dry Eye Summit put forth basic management recommendations for dry eye disease that include the following protocol:

1. For all patients: • Ocular lubrication • Lid hygiene • Nutrition (includes oral nutraceuticals and dietary interventions) 2. Topical anti-infl ammatories when necessary

Improving The Screening, Diagnosis, And Treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit. Available at: https://www.reviewofoptometry.com/ CMSDocuments/2015/6/0615_BioSciencei.pdf (last accessed May 23, 2016).

progressed beyond transient where their discomfort occurs, only do women report to us blur from an unstable tear fi lm along with a list of DED symptoms with a higher to signifi cant SPK [superfi cial that they’ve used in the past. frequency, but they also cite the punctate ] and epi- They are very open about how severity and impact on their thelial desiccation. They may DED is affecting them, beyond daily lives to be greater. exhibit redness, the physical manifestations. and even ocular neuropathic Dr. Hauser: I have also found A Comprehensive hyperactivity and female patients to be more Approach to Diagnosis pain, which are very diffi cult to forthcoming about their ocular Dr. McDonald: Please walk treat.13 symptoms and general well-be- us through your diagnostic Dr. Bitton: I haven’t noticed ing. Many offer a narrative that approach when female patients differences insofar as the provides me with a keener arrive at your practice with actual symptoms that men and of the physical and emotional DED symptoms and how this women mention, but I have impact that DED is having in strategy might differ for a male observed distinctions in the their lives. patient. way they communicate the in- Dr. O’Brien: We have tracked Dr. Hauser: A case history is formation. Female patients are gender-specifi c reporting dif- always a critical component more descriptive, verbally and ferences with regard to DED of any clinical exam, but it’s otherwise; many will come in that may impact management especially important for female with a detailed log of when and and patient satisfaction. Not patients who report dry eye

The Tear Film’s Critical Role The 2007 International Dry Eye WorkShop (DEWS) report, putting forth a new defi nition of dry eye disease (DED) from an earlier defi nition presented at the 1995 National Eye Institute Industry Dry Eye Workshop, highlights the critical role the tear fi lm plays relative to dry eye disease:1 Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discom- fort, visual disturbance, and tear fi lm instability, with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear fi lm and infl ammation of the ocular surface. In deciding upon its phrasing, the committee agreed that the updated language needed to refl ect new knowledge about the roles of tear hyperosmolarity and ocular surface infl ammation in dry eye, along with dry eye’s impact on visual function.

A 2012 article in Clinical and Experimental concluded the following about osmolarity and tear fi lm dynamics2,3,4,5 • Equilibrium in tear fi lm production, retention and elimination is vital to promote ocular surface health • Alterations to any tear fi lm dynamic component will destabilize homeostasis, and lead to ocular surface changes • An imbalance in tear dynamics can be assessed via tear fi lm osmolarity

1. The defi nition and classifi cation of dry eye disease: report of the Defi nition and Classifi cation Subcommittee of the International Dry Eye WorkShop (2007) Ocul Surf. 2007;5(2):75–92. 2. Farris RL. Tear osmolarity—a new gold standard? Adv Exp Med Biol. 1994;350:495-503. 3. Tomlinson A, Khanal S, Ramaesh K, et al. Tear fi lm osmolarity: determination of a referent for dry eye diagnosis. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4309-15. 4. Versura P, Profazio V, Campos EC. Performance of tear osmolarity compared to previous diagnostic tests for dry eye diseases. Curr Eye Res. 2010 Jul;35(7):553-64. 5. Stahl U, Willcox M, Stapleton F. Osmolality and tear fi lm dynamics. Clin Exp Optom 2012; 95: 1: 3–11.

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101516_akorn__rp_jA.indd 4 9/22/16 1:41 PM Increased Tear Film Osmolarity & Dry Eye Regardless of the cause of the DED, whether from aqueous deciency or tear evaporation, the result is the same: increased tear fi lm osmolarity.

• Aqueous defi ciency and increased tear Tear gland dysfunction evaporation can both Aqueous defi ciency lead to hyperosmolarity Decreased corneal sensation Increased Tear Osmolarity=Dry Eye Increased eye exposure Evaporative oil gland dysfunction

Gilbard JP. The Diagnosis and Management of Dry Eyes. Otolaryngol Clin N Am. 2005;38;5:871-85.

symptoms. I often investigate patient history, I aggressively hormonal changes due to birth screen for conditions that put control pills, and women at higher risk for dry perimenopause/menopause. eye or ocular surface disease. Women aren’t always aware Presence of certain systemic that prescriptions originating diseases, use of specifi c medica- from their OB/GYN offi ce to tions, previous cosmetic eyelid address other conditions can surgery or laser vision correc- impact their eye health. Ad- tion, and particular dietary A patient displaying a scant tear meniscus. ditionally, I probe deeper into and environmental exposures Photo: Paul M. Karpecki, OD, FAAO the possibility of autoimmune can play a role in diagnosis. conditions for female patients, Evidence of aqueous tear-defi - asking about joint pain, fatigue, cient dry eye in the setting of educate patients about how their behavior can affect their We will explain to heavy makeup users where ocular health. For example, we will explain to heavy makeup the meibomian glands are located, the role of the users where the meibomian meibomian glands, and the importance of lid hygiene glands are located, the role of the meibomian glands, and the and removing oil, debris and other contaminants that can importance of lid hygiene and build up on the eyelids and . - Dr. Bitton removing oil, debris and other contaminants that can build up on the eyelids and eyelashes. muscle weakness and dry dry mouth and arthritis might Using TheraTears® Sterilid® mouth. Though autoimmune trigger me to test for Sjögren’s twice a day can help the patient diseases affect less than 10% syndrome, in cooperation with maintain a healthy lid margin. of the population, nearly 80% the patient’s internal medicine Dr. Karpecki: For female of those people are women.14 doctor or rheumatologist. patients, I more commonly And diseases like Sjögren’s Dr. Bitton: Typically, I don’t perform ocular surface stain- syndrome can take as long as vary my approach to testing be- ing to assess for Sjögren’s a decade to diagnose. In terms tween genders, although we do syndrome, and recommend of diagnostic testing, I may be ask additional questions about blood testing for the disease. more likely to order tests for DED, dry mouth and overall Given that androgen defi ciency aqueous-defi cient dry eye, in- dryness of mucous membranes can cause dry eye, I am also cluding phenol-red thread and to tease out the possibility of evaluating for symptoms such tear meniscus height. Sjogren’s syndrome. But during as dry mouth or dryness of Dr. O’Brien: In building the the workup, we take time to any mucous membranes, and

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101516_akorn__rp_jA.indd 5 9/22/16 1:42 PM other factors that may provide contraceptives, , Dr. Hauser: Women of all diagnostic clues. as well as HR.15 ages use creams, lotions and At times it may be effi cacious other beauty products around Customizing Therapy for the to comanage with a woman’s their eyes, but doctors rarely Female DED Sufferer gynecologist, internist, rheu- address the potential contribu- Dr. McDonald: Are there matologist, psychologist or tion to ocular surface disease. treatments that you consider psychiatrist to make alterations I regularly ask patients about specifi cally/primarily for female to therapies. the products they use and patients? Dr. Karpecki: I approach how they remove them. One Dr. O’Brien: I look at the treatment for all patients using eyelid cleanser I recommend for overall wellness picture of my a similar strategy as we dis- ongoing management, espe- female patients before laying cussed at the Dry Eye Summit cially for my female patient is out my protocol. Sometimes (see Expert Basic DED Man- TheraTears® SteriLid®. Patients that means subtracting or agement Protocol: Dry Eye prefer the natural formulation adjusting medications being Summit on page 4.) For the containing tea tree oil. And the taken for other conditions that majority of practitioners, this product removes oil, debris and are having unintended negative means starting patients with other contaminants that can effects on the tear fi lm and ocu- ocular lubrication, lid hygiene build up on eyelids and - lar surface. A 2001 study found and nutrition, and then adding es, as part of an easy, 60-sec- that women who use hormone additional treatments as the onds process that the woman replacement therapy (HRT), disease necessitates. A recent can incorporate into their daily particularly estrogen alone, study showed that the combi- regimen. Women seem to be were at increased risk of dry nation of these three treatments more open to aggressive strate- eye syndrome; clinicians should (using: TheraTears® Dry Eye gies to slow DED progression. be aware of this potential com- Therapy Lubricant Eye Drops, I have seen greater reception by plication and build a detailed TheraTears® SteriLid® Eyelid female patients to new proce- history of women’s medica- Cleanser, and TheraTears® Eye dures, and I fi nd less resistance tions, including prescribed/ Nutrition) improved dry eye to and greater compliance with nonprescribed treatments, oral signs and symptoms.16 ocular nutrition recommenda- tions, in my female patients. Transforming Lives With Proper Care Women tend to appreciate a Dr. McDonald: How can the right/appropriate DES care positively impact female wellness model versus waiting patients? to treat a worsening chronic Dr. Bitton: One patient, a 73-year-old female, who came to me for severe condition. evaporative dry eye, could barely open her eyes during the fi rst visit. The woman lived alone and found that she could no longer run quick errands to the bank, Turning to Nutritional pharmacy or grocery store because the dryness had gotten so pervasive. She Supplements admitted that she had lost her independence, and felt angry and embarrassed Dr. McDonald: Are there any that she had to depend on others to do her chores. She felt like a burden to her nutritional supplements geared son and was hesitant to call him. As she recounted her situation, she cried out of toward women with DED? complete desperation. The patient had elevated tear fi lm osmolarity and, hence, If so, which, if any, do you was placed on proper lubricants (e.g., TheraTears® Dry Eye Therapy) that im- incorporate in your treatment/ proved the quality of her tear fi lm. The patient slowly became more independent, management plan? even if it meant she had to break up errands into several trips a day. Follow-up Dr. O’Brien: The use of visits reveal she is improving, so much so that she joined a knitting group. omega-3 essential fatty acid I smile every time I see the patient’s name on my schedule, and this woman supplementation may benefi t continues to thank me for restoring her independence. female DED patients, according 17 Dr. Hauser: Female patients tend to speak very candidly with me during the to a 2013 study. Researchers exam. Perhaps they have a high level of comfort, because they feel like we’re found specifi c improvements talking woman-to-woman. At the conclusion, patients will often say something for disease like, ‘Thank you, I fi nally understand.’ Many doctors think that women with dry and , noting that eye disease just want a cure. Naturally, that would be ideal. However, what most omega-3 fatty acids “have a of them want is answers. Why do I have this? What’s happening to me? Provid- defi nite role in dry eye disease.” ing knowledge and information validates their physical symptoms and emotional (The extent to which omega-3 struggle with the disease. affected tear production and secretion was unknown, as

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101516_akorn__rp_jA.indd 6 9/22/16 1:42 PM not only from a prevalence standpoint but from a holistic perspective. Therefore, it is cru- cial to fi rst aggressively screen women for the presence of dry eye. Secondly, it is imperative that clinicians consider the sys- temic as well as overall effects of DED on the female patient. A systematized approach to restoration of the tear fi lm including qualitative and quantitative strategies, as well as cleansing the lid margins and surroundings to reduce exces- Superfi cial punctate keratitis (SPK) in the lower quadrant is typical of dry eye, especially sive microbial colonization, and with an incomplete blink. Photo: Etty Bitton, OD, MSc, FAAO balancing nutrition towards a noninfl ammatory state ensures investigators indicated further DED patients who became so optimal success in improving exploration was needed.17) despondent prior to seeing me, symptoms and signs, patient Vitamin E can augment an they sought medical assistance satisfaction, and ultimately, omega-3 strategy, since long- for their associated depression. quality of life. ■

term use of fi sh oil may de- Dr. Hauser: Quality of life is 1. Rumpakis J. Economics of Apathy. Rev Optom. plete vitamin E levels. Thus, I one of the most underestimated 2013;150(10) 65-72. ® 2. Schaumberg DA, Sullivan DA, Buring JE, et al. MR recommend TheraTears Eye components of caring for the Prevalence of among US women. Am J Ophthalmol 2003;136 (2) 318-26. Nutrition supplement, which female dry eye patient. Worsen- 3. Schaumberg DA, Dana R, Buring JE, et al. Prevalence of includes vitamin E while ex- ing symptoms, such as blurred dry eye disease among US men: estimates from the Physi- cians’ Health Studies. Arch Ophthalmol. 2009;127(6):763-8. hibiting a favorable balance of vision and irritation, can affect 4. Schaumberg DA, Uchino M, Christen WG, et al. Patient essential fatty acid precursors. the work and home life, which reported differences in dry eye disease between men and women: impact, management and patient satisfaction. PLoS Dr. Karpecki: In some female seems to further magnify symp- One:2013 8(9)e76121. 5. Hemard JB, Monroe PA, Atkinson ES, et al. Rural women’s cases of DED, I feel more toms further for patients and satisfaction and stress as family health care gatekeepers. confi dent in successful results if perpetuate the vicious cycle of Women Health. 1998;28(2):55-77. 6. Dry Eyes: Complications. Mayo Foundation for Medical a patient is taking an omega-3 unhappiness. Education and Research. Available at: http://www.mayoclinic. fatty acid that combines EPA/ Dr. Karpecki: What has org/diseases-conditions/dry-eyes/basics/complications/con- 20024129 (last accessed May 4, 2016). DHA with fl axseed oil, which fascinated me over the years 7. Yilmaz U, Gokler ME, Unsal A. Dry eye disease and depression-anxiety-stress: A hospital-based case control tends to be better metabolized is, when I successfully treat study in Turkey. Pak J Med Sci. 2015; 31(3): 626-31. by women than men. a female patient with DED, 8. van der Vaart R, Weaver MA, Lefebvre C, et al. The association between dry eye disease and depression and they just as often mention how anxiety in a large population-based study. Am J Ophthalmol. 2015 Mar;159(3):470- The Invisible Cost much I’ve affected their lives 9. Buchholz P, Steeds CS, Stern LS, et al. Utility assessment of Dry Eye as their eyes. I’ve had women to measure the impact of dry eye disease. Ocul Surf. 2006;4:155-61. Dr. McDonald: How have you tell me about the confi dence 10. Schiffman RM, Walt JG, Jacobsen G, Doyle JJ, Lebovics observed DED affects women restored in their work and G, Sumner W. Utility assessment among patients with dry eye disease. Ophthalmology. 2003;110:1412–9. from a quality-of-life stand- social lives, now that they no 11. Paulsen AJ, Cruickshanks KJ, Fischer ME et al. Dry eye in the beaver dam offspring study: prevalence, risk factors, point? longer face the world with red, and health-related quality of life. Am J Ophthalmol. 2014 Dr. Bitton: Women don’t just tired-looking eyes, or intrusive Apr;157(4):799-806. 12. Rao S. Progression: The New Approach to Dry Eye. give me their patient history questions about whether they Review of Ophthalmology. 2008;15(10):55-58. 13. Rosenthal P, Borsook D. Ocular neuropathic pain. Br J when they come to see me; have been crying. Other pa- Ophthalmol. 5 May; 2015. [Epub ahead of print]. they tell me about all of the tients say they can fi nally stop 14. Fairweather D, Frisancho-Kiss S, Rose NR. Sex Differences in Autoimmune Disease from a Pathological activities that they’ve limited or worrying that people will think Perspective. Am J Pathol. 2008 Sep; 173(3): 600-9. stopped completely (e.g., leisure they have been drinking alcohol 15. Schaumberg DA, Buring JE, Sullivan DA, et al. Hormone replacement therapy and dry eye syndrome. JAMA. 2001 Nov reading, knitting, going out to or taking drugs. 7;286(17):2114-9. 16. Srinivasan S, Ngo W, Jones LW, et al. The Relief of dinner/shows/activities) due Dr. O’Brien: As has been Dry Eye Signs and Symptoms Using a Combination of to external factors such as air shown by this panel and sup- Lubricants, Lid Hygiene and Ocular Nutraceuticals. ARVO Annual Meeting Abstract. Investigative Ophthalmology & conditioning, wind and heat- porting research, it is clear that Visual Science. 2015 June;56: 4465. 17. Bhargava R, Kumar P, Kumar M, et al. A randomized ing vents, exaggerating their dry eye disease affects women controlled trial of omega-3 fatty acids in dry eye syndrome. condition. I have had female more profoundly than men— Int J Ophthalmol. 2013 Dec 18;6(6):811-6.

7 REVIEW OF OPHTHALMOLOGY • OCTOBER 2016

101516_akorn__rp_jA.indd 7 9/22/16 1:42 PM Not Just Eye Drops, Dry Eye Therapy™

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*These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Reference: 1. Srinivasan S, Ngo W, Jones L. The relief of dry eye signs and symptoms using a combination of lubricants, lid hygiene, and ocular nutraceuticals. Poster presented at: ARVO annual meeting; April 2015; Denver, CO. © 2016 Akorn Consumer Health | A Division of Akorn, Inc. | M16-029

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