CASE 2 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 2 IN A SERIES OF 4 ORIGINAL RELEASE: OCTOBER 4, 2013 EXPIRATION: OCTOBER 4, 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 Joseph Sowka, OD Professor Chief of Advanced Care Service Director of Glaucoma Service Nova Southeastern University College of Optometry Fort Lauderdale-Davie, Florida

2 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 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 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.

3 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. 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 Gaddie: The patient is a 53-year-old woman with primary open-angle glaucoma who was initially treated with travoprost with non-benzalkonium chloride (BAK) preservative (brand formulation) (Travatan Z). Her intraocular pressures (IOPs) were well controlled on this medication, decreasing from 21 mm Hg in each eye to 14 mm Hg in each eye. At the beginning of this year, her insurance company forced her to switch from this branded travoprost to latanoprost preserved with BAK (generic formulation). Within a month of the switch, the patient began to experience severe itching, welt-like lesions around her face, neck, eyes, and adnexa. She sought treatment from her dermatologist and was treated empirically with topical steroids, without success. At this time, the patient came to my office for her scheduled IOP check.

4 EXAMINATION Allergy History: None Past Medical History: Hypertension, acid reflux Nonocular Medications: Hormone replacement therapy, losartan Ocular History: 9-year history of primary open-angle glaucoma Visual Acuity (Best Corrected With Compound Myopic Astigmatic Spectacle Prescription): 20/20 OD 20/20 OS Anterior Segment Examination: Conjunctiva: Normal Eyelids: Mild squamous blepharitis OU Cornea: Normal Anterior chamber (including angle assessment): Anterior chamber clear with wide open angle; gonioscopy revealed scleral spur present 360 degrees OU with 1 + pigmented trabecular meshwork Lens: Trace nuclear sclerosis OU IOP: 14 OD 15 OS Pachymetry: 600 OD 605 OS Optic Nerve/Retinal Nerve Fiber Layer (RNFL)/Retina: Optic Nerve (Figures 1A and 1B)

5 Figure 1A. Retinal photograph of the patient's optic nerve of the right eye. Figure 1B. Retinal photograph of the patient's optic nerve of the left eye. Photos Courtesy of Ian Benjamin Gaddie, OD RNFL/Retina: (Figure 2)

Figure 2. Optical coherence tomography report for the optic nerve head and RNFL of both eyes. There is thinning of the RNFL, greater in the right eye. Small Disc Size OU (1.46 mm and 1.

6 Figure 2. Optical coherence tomography report for the optic nerve head and RNFL of both eyes. There is thinning of the RNFL, greater in the right eye. Small Disc Size OU (1.46 mm and 1.63 mm) Inferior, superior, nasal, and temporal (ISNT) Rule is obeyed/myopic-stretched appearance No hemorrhage present Zone Alpha and Beta Parapapillary atrophy present OU/Some crescent OS C/D.7.65 Cirrus Optical Coherence Tomography imaging performed Inferior RNFL void located in the inferior vascular bundle region OU Looks like a symmetrical, congenital variation of RNFL. Also, superior/temporal RNFL wedge defect OS>OD Visual fields (SITA Standard): Good reliability OU No glaucomatous defects OU ASSESSMENT The patient appeared to be having an allergic reaction. My initial thought was that she had touched something to which she was allergic and then touched her face and eyes. However, after she described

7 her recent history, I began to suspect that her allergic reaction might have been related to the change in her ocular antihypertensive medication. I referred her to another dermatologist with expertise in pathology, and we collaborated in managing her condition. The dermatologist treated her symptomatically at first, using intramuscular steroid injections and topical creams. When that treatment did not eliminate her symptoms, the dermatologist and I systematically removed, first, all her topical dermatologic medications and then the latanoprost with BAK. Her symptoms ceased after all medications were discontinued. Her dermatologist also performed biopsies of her facial nodules and performed skin patch testing, all of which produced negative results. DISCUSSION Dr Fingeret: Common patient reactions to ocular medications are shown below. (Table) How would we evaluate this patient to determine if she had an allergic reaction to latanoprost with BAK? Dr Sowka: Many of these reactions are often diagnosed by process of elimination. A concrete test would be exposure to BAK alone to see if the reaction was repeated. Would anyone consider conducting a challenge-rechallenge trial of her ocular antihypertensive? Table. Types of Patient Reactions to Ocular Medications 1,2 Type of Reaction Definition Possibility of Continuing Agent Symptoms Local or Systemic Reaction Sensitivity Greater than commonly experienced adverse effects to an agent Yes, but with discomfort Discomfort, irritation Local Intolerance High degree of sensitivity that precludes continued use of the agent No Burning, stinging, irritation Local Allergy Immune system hypersensitivity reaction No Itching, rash, welts, skin peeling, hyperemia, chemosis (swelling of conjunctival tissue around the cornea) Local and/or Systemic Dr Gaddie: That is in essence what I did. Because her reaction to generic latanoprost was severe, I rechallenged her with a different BAK-preserved prostaglandin analog, bimatoprost preserved with BAK. As mentioned earlier, after the dermatologist and I discontinued all her therapies, her reaction resolved. After 6 weeks without medication to treat her glaucoma, I initiated bimatoprost ophthalmic solution, and the patient had a recurrence of allergic symptoms. At this point, I began to suspect it was the BAK preservative common to both ocular antihypertensives involved that may have been the culprit in her allergic reactions, both initially and upon rechallenge. The dermatologist had not tested for BAK allergy, however, and her other skin patch testing results were negative. The dermatologist and I suspected that the patient had experienced an allergy to BAK, because when we took away the BAK, the reaction went away. When we resumed a BAK-preserved ocular antihypertensive, the allergic reaction returned. Dr Sowka: This was a good challenge because both latanoprost and bimatoprost, assuming that the 0.01% concentration was used, are among the highest BAK-containing products. Dr Hom: In this case, I believe that Dr Gaddie's plan to rechallenge the patient with the suspected allergen was a good one. I observed another clue indicating that the patient may have experienced an

8 allergic reaction: typically, if patients have any allergic symptoms such as a rash that appears at a site other than at the point of contact with the allergen, that indicates an allergic reaction may be occurring. The fact that Dr Gaddie observed welts on the patient's neck and areas around the eye, rather than in the eye, points to an allergic reaction. Although an allergic reaction may manifest in the eye as hyperemia or chemosis, this patient's reaction would not likely be a typical presentation for BAK irritation. Because of the nature of my practice, I would assess for allergic symptoms presenting on the patient's ocular surface. I probably would have given the patient a TOSS Questionnaire, although it is not validated. A TOSS (Total Ocular Symptom Score) Questionnaire is based on answers to 4 questions that quantify the frequency with which a patient experiences eye irritation during a previous week's time. The questionnaire asks: 1. How often do you have itching? 2. How often do you have watering? 3. How often do you have swelling? 4. How often do you have redness? The patient can answer: none of the time (0), some of the time (1), half the time (2), most of the time (3), or all of the time (4). The corresponding numerical values (set in parentheses) to these answers are calculated as follows to determine the patient's TOSS score: TOSS Score = [(sum of scores) x 25] / (number of questions answered) I would compare this case patient's baseline TOSS score with subsequent TOSS scores at follow-up visits to assess changes in the degree of her eye irritation. Dr Fingeret: Does the TOSS Questionnaire help us if the patient's eyes are white and the test answers are all negative? Dr Hom: Yes, while the patient's eyes may have appeared white and normal at the time of the visit, they may not have been so during the previous week. Asking the TOSS questions all of which include the words how often allows the clinician to determine the frequency of eye irritation a patient experiences. By conducting the TOSS as a baseline, we can more accurately compare changes in the degree of ocular irritation between appointments. Dr Fingeret: How can clinicians differentiate between an allergic reaction to BAK and an intolerance to BAK? Are there any tests we can perform to differentiate between BAK allergy and BAK intolerance? Dr Hom: Although I am not aware of any ocular tests that a general optometrist can perform to differentiate BAK intolerance from BAK allergy, an allergist may be able to perform skin patch testing for allergy to BAK. The dermatologist in this case may not have been aware of the availability of skin patch testing for BAK allergy. In a 2012 study by Benjamin and colleagues, researchers examined skin biopsies of participants to evaluate their reaction to BAK exposure. They found that irritant reactions occurred in more superficial layers of the skin and did not itch or peel. Participants were subsequently able to successfully use the irritating agents at lower concentrations. On the other hand, allergic reactions occurred in deeper layers of the skin and were characterized by microvesicle formation that appeared 4 days following exposure. Because allergic reactions can be worse in subsequent exposures because of the sensitization of the immune system, continued use of the offending agent is not advisable. The researchers cautioned, however, that irritation to BAK could contribute to false-positive results to BAK allergy testing. 2 Likewise in 2012, Dao and colleagues examined the results of skin patch testing of BAK to determine the prevalence of irritation (intolerance) and/or sensitization (allergy). The investigators performed both early (48-96 hours) and late (7 days) skin patch readings on participants, trying to differentiate between irritation and allergy. The results of their study agree with those of many prior case studies, that although

9 allergic reaction to BAK is rare, it does occur. 3 The Dao study substantiates an earlier study by Uter and colleagues that determined through clinical skin patch testing of BAK, 0.1%, that BAK contact allergy positive reactions occur at a rate of 0.6% to 1.5%. 4 Dr Gaddie: Because those studies were published as recently as 2012, I doubt that either the findings from these investigations or the awareness of skin patch testing for BAK is widely known around the country yet. Dr Hom: Yes, the skin patch test for BAK is probably not well known, but I believe that it is prudent for patients with a suspected BAK allergy to consult an allergist who could perform such skin patch testing. Dr Fingeret: This case highlights the need for optometrists to be aware that, although rare, 3 BAK allergy does occur, and that we should be familiar with its presentation. Also, we should educate patients on what to watch for, especially when they are starting a new medication. I ask my patients during their office visit to remember how they feel that day. I then tell them that If anything changes after starting the medication, such as their energy level or how they feel in general not just in their eyes but anywhere in their body to stop the drug and to alert me. If patients pay closer attention to their symptoms after medication changes, it may speed our diagnosis and treatment of their condition. In addition, we should ask patients to let us know if they have been switched to another agent or to a generic formulation. It can occur that a branded product is switched to a generic product without a prescriber's knowledge. With mail order, the generic product may be mailed to the patient without any instructions. When a medication or even a formulation of a medication is changed, be aware that your patient may experience any of several reactions, possibly of a negative nature. REFERENCES 1. Stalmans I, Sunaric Mégevand G, Cordeiro MF, et al. Preservative-free treatment in glaucoma: who, when, and why. Eur J Ophthalmol. 2013;23(4): Benjamin B, Chris F, Salvador G, Melissa G, Susan N. Visual and confocal microscopic interpretation of patch tests to benzethonium chloride and benzalkonium chloride. Skin Res Technol. 2012;18(3): Dao H Jr, Fricker C, Nedorost ST. Sensitization prevalence for benzalkonium chloride and benzethonium chloride.dermatitis. 2012;23(4): Uter W, Lessmann H, Geier J, Schnuch A. Is the irritant benzalkonium chloride a contact allergen? A contribution to the ongoing debate from a clinical perspective. Contact Dermatitis. 2008;58(6): Back to top

CASE 1 IN A SERIES OF 4

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: