CASE 1 IN A SERIES OF 4

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1 ONLINE CE NEWSLETTER SERIES FOR OPTOMETRISTS WITH ONLINE TESTING AND INSTANT CE CERTIFICATE Eye on Glaucoma TM Case Chronicles in Glaucoma and Ocular Surface Disease CASE 1 IN A SERIES OF 4 ORIGINAL RELEASE: AUGUST 21, 2013 EXPIRATION: AUGUST 19, 2016 This course is COPE approved for 1 credit. COPE Course ID: GL Sponsored by The State University of New York College of Optometry Administrator: MedEdicus LLC This continuing education activity is supported through an unrestricted educational grant from Merck & Co, Inc. FACULTY Murray Fingeret, OD, FAAO (Program Chair) Chief of the Optometry Section Brooklyn/St. Albans Campus Department of Veterans Affairs New York Harbor Healthcare System Clinical Professor State University of New York College of Optometry. New York, New York Ian Benjamin Gaddie, OD Owner and Director Gaddie Eye Center Louisville, Kentucky Milton Hom, OD Private Practice Azusa, California

2 Joseph Sowka, OD Professor Chief of Advanced Care Service Director of Glaucoma Service Nova Southeastern University College of Optometry Fort Lauderdale-Davie, Florida LEARNING METHOD AND MEDIUM This educational activity consists of a case report and ten (10) study questions. The participant should, in order, read the Learning Objectives contained at the beginning of this activity, read the material, answer all questions in the post test, and complete the Activity Evaluation/Credit Request form. To receive credit for this activity, please follow the instructions provided below in the section titled To Obtain CE Credit. This educational activity should take a maximum of 1.0 hour to complete. CONTENT SOURCE This continuing education (CE) activity captures content from a roundtable discussion. ACTIVITY DESCRIPTION There is a growing awareness of the impact of ocular surface disorders on the successful management of patients with ocular hypertension and glaucoma. Recent studies provide new insights into patient problems and concerns, and an increasing awareness of the significance of preservatives on ocular health. Improved versions of current therapies, and the availability of new therapies, provide opportunities for improved outcomes toward the prevention of glaucoma progression. Recently, a group of experts convened to discuss their insights and approaches for managing these patients. This CE activity brings you highlights from these case discussions in a 4-part series. TARGET AUDIENCE This educational activity is intended for optometrists. LEARNING OBJECTIVES Upon completion of Part 1 of this 4-Part CE Case Series, participants will be better able to: Assess ocular surface health in patients on ocular antihypertensives Review the evidence on the effects of preservatives on the ocular surface as they relate to ocular hypertension treatment regimens Employ appropriate ocular antihypertensive strategies in patients with glaucoma or ocular hypertension to manage OSD

3 ACCREDITATION DESIGNATION STATEMENT This course is COPE approved for 1.0 hour of CE credit for optometrists. COPE Course ID: GL DISCLOSURES Murray Fingeret, OD, had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Alcon, Inc; Allergan, Inc; Carl Zeiss Meditec, Inc; Sucampo Pharmaceuticals, Inc; and Topcon Medical Systems, Inc; Contracted Research: Canon USA, Inc; Carl Zeiss Meditec, Inc; Heidelberg Engineering; and Topcon Medical Systems, Inc. Ian Benjamin Gaddie, OD, had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Alcon, Inc; Allergan, Inc; Bausch + Lomb Incorporated; Marco Medical Management LLC; Merck & Co, Inc; OCuSOFT; and Sucampo Pharmaceuticals, Inc. Milton Hom, OD, had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Allergan, Inc; Bausch + Lomb Incorporated; NicOx SA; and SARcode Bioscience, Inc; Contracted Research: Abbott Medical Optics; Allergan, Inc; and Bausch + Lomb Incorporated. Joseph Sowka, OD, had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant/Advisory Board:Alcon, Inc; Merck & Co, Inc; and Sucampo Pharmaceuticals, Inc; Fees for promotional, advertising or non-cme services received directly from commercial interest or their Agents (eg, Speakers Bureaus): Alcon, Inc; and Carl Zeiss Meditec, Inc. DISCLOSURE ATTESTATION Each of the contributing physicians listed above has attested to the following: 1. that the relationships/affiliations noted will not bias or otherwise influence his or her involvement in this activity; 2. that practice recommendations given relevant to the companies with whom he or she has relationships/affiliations will be supported by the best available evidence or, absent evidence, will be consistent with generally accepted medical practice; and 3. that all reasonable clinical alternatives will be discussed when making practice recommendations. OFF-LABEL DISCUSSION This activity does not include off-label discussion of any agents. Please consult products for all approved indications and administration.

4 GRANTOR STATEMENT This CE activity is supported through an unrestricted educational grant from Merck & Co, Inc. TO OBTAIN CE CREDIT We offer instant certificate processing and support Green CE. Please take this post test and evaluation online by going to and clicking the Educational Activities/Post-Test & CE Certificate box. Upon passing, you will receive your certificate immediately. You must answer 7 out of 10 questions correctly in order to pass, and may take the test up to 2 times. Upon registering and successfully completing the post test, your certificate will be made available online and you can print it or file it. Please make sure you take the online post test and evaluation on a device that has printing capabilities. There are no fees for participating in and receiving CE credit for this activity. DISCLAIMER The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of The State University of New York College of Optometry; MedEdicus LLC; Merck & Co, Inc; or Review of Optometry. CASE PRESENTATION Dr Hom: A 56-year-old woman, first-time patient, presented to my clinic for an evaluation. She has no history of glaucoma and she has no complaints of dry eye or other symptoms of ocular surface disease (OSD). Refractive Correction: R x 90 L x Per normal protocol in my practice, the patient undergoes both Ocular Surface Disease Index (OSDI) and Subjective Evaluation of Symptom of Dryness (SESoD) screenings. Her OSDI score is 18, signifying mild dry eye, and her SESoD answer is "Never," indicating that she had no complaints of dry eye in the past week. Upon expression of the patient's lower lids, grade 2 meibomian gland dysfunction is present in both eyes. Mild debris can be seen on the patient's upper lid lashes, indicating mild blepharitis. (Figure 1) External examination finds palpebral conjunctival redness grade 2-3. (Figure 2)

5 Installation of fluorescein dye finds grade 2 conjunctival staining in both eyes, indicating roughened or damaged ocular surface (Figures 3A, 3B, 3C); there are, however, no signs of corneal staining in either eye.

6 The patient s Schirmer test score is 8 mm in each eye, demonstrating borderline aqueous tear deficiency.

7 Her baseline intraocular pressure (IOP) is 27/29 mm Hg. Fundoscopic examination finds a cup-to-disc ratio of 0.6. Visual field defects are present in both eyes, commensurate with glaucoma. Ganglion cell complex (GCC) analysis shows superior thinning in the right eye. GCC: RE 72/67 LE 74/76 (Figure 4)

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9 Corneal pachymetry as measured by optical coherence tomography finds central corneal thickness of 523 microns OD and 535 microns OS. ASSESSMENT Based on the results of the patient's examination, she is diagnosed with glaucoma, with preexisting mild OSD. DISCUSSION Dr Sowka: Dr Hom, what prompted you to use the OSDI screening if the patient did not have complaints of dry eye? Dr Hom: Because my practice specializes in OSD, virtually all my patients are prescreened and scored with the OSDI and the SESoD by an assistant before I see them. Admittedly, this examination sequence is in reverse order to the procedure followed by nonspecialist optometrists, who would probably use these screening questionnaires only after patients complain of OSD symptoms. As was the case with this patient, however, performing an OSDI helps me to take notice of problems I might otherwise miss if I relied solely on patient history. Dr Fingeret: Dr Hom, please explain the tools that you used to assess this patient's ocular surface. Dr Hom: The OSDI is a validated questionnaire that is frequently used to assess dry eye severity. It contains 12 questions covering 3 different domains: ocular symptoms, vision-related function, and environmental triggers. 1,2 (Table 1) Table 1. OSDI Questions and Scoring 1,3 Domain Questions All of the time Most of the time Half of the time Som e of the time None of the time Domain 1: Ocular Symptoms Have you experienced any of the following during the last week? 1. Eyes that are sensitive to light? Eyes that feel gritty? Painful or sore eyes? Blurred vision? Poor vision? Subtotal for answers 1 to 5 (A) Domain 2: Vision-Related Function

10 Have problems with your eyes limited you in performing any of the following during the last week? 6. Reading? N /A 7. Driving at night? N /A 8. Working with a computer or bank machine (ATM)? N /A 9. Watching TV? N /A Domain 3: Environmental Triggers Have your eyes felt uncomfortable in any of the following situations during the last week? Subtotal for answers 6 to 9 (B) 10. Windy conditions? N /A 11. Places or areas with low humidity (very dry)? N /A 12. Areas that are air conditioned? N /A Subtotal for answers 10 to 12 (C) Add subtotals A + B + C to obtain D (D) Total number of questions answered (do not include questions answered N/A) (E) OSDI Score = [(sum of scores D) x 25)] / number of questions answered E OSDI instrument introduced in 1997 by Outcomes Research Group; Allergan, Inc; Irvine, California. When calculated, the OSDI is assessed based on scores between 0 and 100, with higher scores representing a greater degree of dry eye disease. 1 (Table 2) The OSDI questionnaire takes approximately 3 minutes for the patient to complete, 4 and my assistant scores it before I see the patient. Table 2. OSDI Grading and Degree of Dry Eye Disease 4 OSDI Score Degree of Dry Eye Disease 0-12 Normal Mild Dry Eye

11 23-32 Moderate Dry Eye Severe Dry Eye The other screening test that I use in clinical practice is the SESoD, which calculates the frequency-of-dryness score. 2,4 It asks the patient a single question: "Over the past week, how often did you experience dryness?" 5 Patients must choose an answer from this list: never, seldom, sometimes, frequently, and always. 2 I have found that some of the answers may correlate to degree of eye dryness. 2 (Table 3) Table 3. Dr Hom s Assessment of Dry Eye Severity Based on SESoD Patient s Self-Assessed Dry Eye Frequency Sometimes Frequently Always Dry Eye Severity Mild Dry Eye Moderate Dry Eye Severe Dry Eye In this case, the patient's OSDI score was 18, indicating mild dry eye, despite the fact the she stated that she did not experience any dry eye symptoms over the past week. I often see conflicting results between what my patients report about the frequency with which they experience dry eye and the results of their dry eye screens. Moreover, there often is a disconnect between signs and symptoms of OSD, which makes it difficult to determine the presence or severity of OSD in some patients. This patient's OSDI score, the redness of her palpebral conjunctiva, the fluorescein staining of her conjunctiva, the existence of borderline aqueous tear deficiency, and the evidence of meibomian gland dysfunction indicate that there is an underlying OSD. There was no evidence of corneal staining despite the presence of conjunctival staining. This is a common presentation and illustrates an important clinical concept. I have found that corneal staining is not a sensitive indicator of dry eye, particularly of mild dry eye: I usually do not see corneal staining until the patient has moderate to severe dry eye. On the other hand, I have found conjunctival staining to be a much more reliable indicator of dry eye. Thus, it is important for clinicians to not limit their investigation to corneal staining, because it is conjunctival staining that can provide clues to the state of the patient's ocular health. 2 Dr Fingeret: Dr Hom, because your OSD screening is more complete because of your specialized type of practice, is there an ocular surface screening assessment that could be routinely performed on every patient with glaucoma? How might an optometrist screen for ocular surface problems? Dr Hom: An easy way to assess the ocular surface is to start by asking the single question of the SESoD: "Over the past week, how often did you experience dryness?" If

12 the patient responds with a frequency greater than "seldom," the clinician could then decide to make use of the OSDI questionnaire. 2 However, even for patients with ocular hypertension without complaints of dry eye symptoms, having a baseline OSDI score on record can be particularly useful in monitoring the effect of ocular antihypertensive treatment on the ocular surface. A baseline score can be compared with a patient's posttreatment OSDI scores to monitor dry eye severity during treatment. 2 Dr Fingeret: What are suitable glaucoma therapies for this patient, given newly diagnosed glaucoma and a mild OSD presentation? Dr Sowka: In this asymptomatic patient, who presents with mild signs of OSD, any first- line ocular antihypertensive, such as a prostaglandin analog, would be acceptable. In that she is asymptomatic and mild OSD was found only on screening, I do not feel that we automatically need to avoid benzalkonium chloride (BAK)-containing medications at this point. Considering that half the prostaglandin analogs contain BAK, and depending on affordability and what her insurance formulary dictates, there is a strong chance that this patient will initially be started on a BAK-containing medication. In all likelihood, she would tolerate this well. Now, if the patient reports any dry eye symptoms after starting initial treatment for glaucoma, a change to an ocular antihypertensive that is not preserved with BAK would then be indicated. One option is travoprost preserved with sofzia, which has been shown to improve ocular surface signs and symptoms while still effectively lowering IOP in patients switched to this agent from a BAK-preserved prostaglandin analog. 6 Also, a preservative-free agent would be appropriate for this patient. Dr Gaddie: I think Dr Sowka s approach is the most commonly practiced among general optometrists and ophthalmologists, but I agree with Dr Hom that identifying patients with mild to moderate dry eye, who are often asymptomatic, is desirable. Use of the OSD questionnaires coupled with a comprehensive ocular surface examination will reveal a surprising number of dry eye patients. Dr Hom: Prior to initiation of any ocular antihypertensive therapy, consideration should be given to the patient's preexisting OSD. We know that BAK is a preservative that is included in multiuse ophthalmic preparations to preserve the sterility of the bottle contents. 7 BAK is also a detergent, and enhances the penetration of the active medication into the cornea. However, chronic exposure to BAK has been shown to increase symptoms of ocular discomfort. 7,8 There is ample evidence in the literature that BAK can be toxic to the ocular surface even at low concentrations. 7,9,10 BAK can disrupt the corneal and conjunctival epithelium, 11,12 promote infiltration of inflammatory cells, 13 destroy goblet cells, 14 and trigger programmed and pathologic cell death even at low concentrations. 15 Dr Fingeret: Dr Hom, how did you manage this patient?

13 Dr Hom: This patient was treatment-naïve but already had signs of OSD. I chose to prescribe a preservative-free prostaglandin to avoid aggravating any underlying OSD. There is evidence to support this decision. For example, a study by Rossi and colleagues found that preservative-free tafluprost effectively lowered IOP without causing OSD in newly diagnosed glaucoma patients. 16 Dr Fingeret: It is essential that optometrists consider carefully the effects of preservatives on the ocular surface when selecting ocular antihypertensive therapy. Intolerance to the deleterious effects of preservatives in ocular antihypertensives may adversely affect adherence to glaucoma therapy. 17,18 REFERENCES 1. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000;118(5): Hom MM, Nguyen AL, Bielory L. Allergic conjunctivitis and dry eye syndrome. Ann Allergy Asthma Immunol. 2012;108(3): Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011;52(12): Miller KL, Walt JG, Mink DR, et al. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010;128(1): Hom MM, Bruce AS. Prelens tear stability: relationship to symptoms of dryness. Optometry. 2009;80(4): Horsley MB, Kahook MY. Effects of prostaglandin analog therapy on the ocular surface of glaucoma patients. Clin Ophthalmol. 2009;3: Noecker RJ, Herrygers LA, Anwaruddin R. Corneal and conjunctival changes caused by commonly used glaucoma medications. Cornea. 2004;23(5): Katz G, Springs CL, Craven ER, Montecchi-Palmer M. Ocular surface disease in patients with glaucoma or ocular hypertension treated with either BAK-preserved latanoprost or BAK-free travoprost. Clin Ophthalmol. 2010;4: Ammar DA, Kahook MY. The effects of combination glaucoma medications on ocular surface epithelial cells. Adv Ther. 2009;26(10): Baudouin C. Side effects of antiglaucomatous drugs on the ocular surface. Curr Opin Ophthalmol. 1996;7(2): Kaur IP, Lal S, Rana C, Kakkar S, Singh H. Ocular preservatives: associated risks and newer options. Cutan Ocul Toxicol. 2009;28(3): Denoyer A, Ossant F, Arbeille B, et al. Very-high-frequency ultrasound corneal imaging as a new tool for early diagnosis of ocular surface toxicity in rabbits treated with a preserved glaucoma drug. Ophthalmic Res. 2008;40(6): Baudouin C, Riancho L, Warnet JM, Brignole F. In vitro studies of antiglaucomatous prostaglandin analogues: travoprost with and without benzalkonium chloride and preserved latanoprost.invest Ophthalmol Vis Sci. 2007;48(9): Liang H, Baudouin C, Labbe A, Riancho L, Brignole-Baudouin F. Conjunctiva- associated lymphoid tissue (CALT) reactions to antiglaucoma prostaglandins with or without BAK-preservative in rabbit acute toxicity study. PloS One. 2012;7(3):e33913.

14 15. De Saint Jean M, Brignole F, Bringuier AF, Bauchet A, Feldmann G, Baudouin C. Effects of benzalkonium chloride on growth and survival of Chang conjunctival cells. Invest Ophthalmol Vis Sci.1999;40(3): Rossi GC, Pasinetti GM, Raimondi M, et al. Efficacy and ocular surface tolerability of preservative-free tafluprost %: a 6-month, single-blind, observational study on naïve ocular hypertension or glaucoma patients. Expert Opin Drug Saf. 2012;11(4): Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003;12(5): Schwartz GF, Quigley HA. Adherence and persistence with glaucoma therapy. Surv Ophthalmol. 2008;53 suppl 1:S57-S68. Back to top Print Take Exam