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CORNEA/EXTERNAL DISEASE A Treatment Option for Moderate-to-Severe Dry Eye Syndrome Implanting a hydroxypropyl cellulose insert. BY JODI LUCHS, MD D ry eye syndrome is a chronic, progressive disease that may permanently damage the ocular surface if not adequately treated. Its symptoms adversely affect visual function, the performance of the activities of daily living, and quality of life.1 The Beaver Dam Eye Study demonstrated that the incidence of dry eye increases with age, from more than 10% among those aged 48 to 59 years to nearly 18% in those aged 80 years or older.2 The use of a of a self-administered hydroxypropyl cellulose insert is an effective treatment option for patients suffering from moderate-to-severe dry eye syndrome. ADVANCES IN TREATMENT Dry eye patients seek relief of the symptoms that hamper their lives and, in some cases, severely limit activities such as reading, operating a computer, working, driving, and watching television.3 The Report of the Management and Therapy Subcommittee of the International Dry Eye Work Shop (DEWS) noted that, although dry eye symptoms can rarely be eliminated, they can be improved, thus enhancing the individual’s quality of life.4 Dry eye is a multifactorial condition, the contributing causes of which can include aging, hormonal changes during menopause, a dry environment, sun exposure, common systemic medications, LASIK, ocular injury, and other problems with the eye or eyelids. For that reason, a combination of treatments is frequently prescribed.5 In recent years, dry eye treatment has received greater attention from eye care practitioners, as their knowledge base and treatment options have increased considerably. In addition to artificial tears and ointments, treatments may include anti-inflammatory agents and punctal plugs or other surgeries. Figure 1. The Lacrisert hydroxypropyl cellulose insert. LIMITATIONS ON TREATMENT OF MODERATE-TO-SEVERE DRY EYE There is, however, a subset of patients already on multifaceted treatment regimens who have persistent symptoms and require additional relief. These patients tend to have moderate-to-severe dry eye. In a 2008 survey of ophthalmologists, 94% of respondents agreed that more treatment options are needed for moderate-to-severe dry eye. Only 33% overall felt that current therapies were extremely or very effective for moderate cases and only 5% for severe disease.6 One issue in the management of moderate-to-severe dry eye has been the lack of correlation between patients’ symptoms and the results of clinical tests. This discrepancy may be due to the variability of the disease process, the subjective nature of symptoms, and the variability of responses to questions about physical sensations in the eyes.1 However, in general, patients with moderate-tosevere disease are typically those with DEWS severity levels 2 through 4.7 The foremost objectives in caring for patients with dry eye disease are to improve their ocular comfort and return the ocular surface and tear film to a normal, homeostatic SEPTEMBER 2010 ADVANCED OCULAR CARE 37 CORNEA/EXTERNAL DISEASE Figure 2. Demonstration of the insertion of the Lacrisert. state.4 In their quest for ocular comfort and relief of symptoms, patients with moderate-to-severe dry eye often report that they need to frequently use lubricants such as artificial tears, which can be inconvenient.1 The use of punctal plugs is another step in treating moderate-to-severe dry eye, especially when the condition is unresponsive to artificial tear drops and ointments. Punctal plugs can increase comfort and reduce the frequency with which some dry eye patients use artificial tears . HYDROXYPROPYL CELLULOSE INSERT An alternative to the frequent use of artificial tears is Lacrisert (Aton Pharma, Inc.). This hydroxypropyl cellulose prescription insert helps to retain moisture, stabilize the tear film, and lubricate the eye (Figure 1). The insert is approved by the FDA for use in patients with moderate-to-severe dry eye syndrome. It contains 5 mg of hydroxypropyl cellulose. The patient places the insert into the inferior cul-de-sac of his or her eye (Figure 2), where the medication slowly dissolves over the course of a day and acts to thicken the precorneal tear film. A plastic applicator supplied with the product helps the patient to administer the medication. Lacrisert was approved by the FDA and introduced more than 20 years ago. Because dry eye awareness was lower and practitioners were less aggressive about treating it, however, the medication was not widely used and was in scarce supply until 2006, when Aton Pharma Inc. acquired the rights to distribute it. It is one of only two prescription medications specifically indicated for use in dry eye treatment. Past clinical studies have demonstrated the insert’s ability to improve dry eye symptoms, to increase tear film breakup time, and to decrease rose bengal staining.8-13 HYDROXYPROPYL CELLULOSE INSERT REGISTRY STUDY RESULTS A recent large, multicenter patient registry study found that Lacrisert significantly decreased ocular surface disease index (OSDI) scores in patients with moderate-to-severe dry eye after 1 month of treatment.14 A patient registry study is designed to examine a wide range of correlations and show predictive relationships in a 38 ADVANCED OCULAR CARE SEPTEMBER 2010 Figure 3. Change in mean OSDI scores by dry eye severity group. Figure 4. Change in distribution of patients within dry eye severity groups. “real-world” situation. In a registry, clinicians may choose to continue or discontinue the patient’s previous treatment regimen. This allows the collection of data that reflect treatments employed in actual clinical practice, a key consideration for a condition requiring multifaceted treatment like dry eye. The multicenter study enrolled 520 patients, aged 18 or older, with a diagnosis of bilateral dry eye syndrome and a history of using artificial tears. At their first visit, patients were given a general dry eye evaluation, screened by slitlamp biomicroscopy and BCVA, and were required to fill out a questionnaire that included the OSDI, a validated measure of quality of life. The patients enrolled in the study were then categorized according to their OSDI scores as severe, moderate, mild, or normal. Patients were trained on the proper insertion and use of Lacrisert. They were contacted by telephone on day 3 of the study for follow-up and reinstruction. At the second visit (week 4), patients were given a clinical evaluation and required to complete a second evaluation. Answers provided on questionnaires (scored on Likert-type scales) were used to determine changes in patient-reported outcomes such as symptoms and quality of life. In patients who completed the study (n = 418), analysis of variance showed significant differences in OSDI scores between severity groups after 4 weeks of treatment with CORNEA/EXTERNAL DISEASE Lacrisert (Figure 3). The largest decrease CLINICAL APPLICATION in scores was 29.8% in the severe group The author prescribes Lacrisert for (P < .001). Scores in the moderate group symptomatic relief to patients who show decreased by 18.9% (P = .016). signs of moderate-to-severe dry eye, Improvements in OSDI scores for especially those who use artificial tears patients in the study were over and frequently (six or more times daily). above any improvement patients might Lacrisert is a lubricant, so relief is immehave gained from dry eye therapies diate. Because the insert has no interacadministered before the study. Blurred tions with other ocular medications, it is vision was the most common adverse not contraindicated in patients who use effect, reported by 8.7% of study particiother dry eye products, including pants overall. cyclospoprine. Lacrisert can be comIt should be noted that, within the bined with other medications, such as Figure 5. Change in frequency of normal and mild OSDI groups, there anti-inflammatory drugs, if greater treatdifficulty in performing activities of were significant increases in OSDI scores ment is required. daily living within the severe group. of 83.7% (P = .001) and 30.2% (P = .01), If patients are experiencing some blurrespectively. In these cases, thickening an ring in the hours following insertion, the adequate precorneal tear film may result author recommends Lacrisert be insertin some blurring of vision. In mild cases of ed in the evening. Insertion at night dry eye, any increase in blur may be perallows them to overcome this transient ceived by the patient as “poor vision.” issue while they are sleeping and still Blurriness and poor vision both are comexperience the benefits of the sustained ponents of the OSDI. release of tears throughout the day. ■ A shift in the distribution of patients Dr. Luchs is an assistant clinfrom severe to less severe was also noted ical professor of ophthalmology (Figure 4). At baseline, 78% of patients and visual sciences at the who completed the study were classified Albert Einstein College of as moderate to severe using the OSDI. Figure 6. Increase in tear film Medicine in Bronx, New York, After 4 weeks of therapy, only 59% were breakup time within the severe codirector of the Department of Refractive categorized as moderate to severe. The group. Surgery at the North Shore/Long Island normal and mild populations almost Jewish Health System in New York, and doubled in size. director of clinical research and cornea/external disease at In the group classified as severe OSDI, 65.3% of patients South Shore Eye Care in Wantagh, New York. He has received initially scored within the severe range. After 4 weeks of honoraria from Aton Pharma, Inc., for consulting services. therapy, only 44% of the group scored within the severe Dr. Luchs may be reached at (516) 785-3900; [email protected]. range, shifting the distribution to normal, mild, and moderate groups. Within the severe group, the frequency of diffi1. The epidemiology of dry eye disease:report of the epidemiology subcommittee of the international dry eye workshop culty performing the activities of daily living decreased (2007). Ocul Surf.2007;5(2):93-107. 2. Moss SE,Klein R,Klein BE.Incidence of dry eye in an older population.Arch Ophthalmol.2004;122(3):369-373. (Figure 5); there was a significant improvement in reading, 3. Miljanovic B,Dana R,Sullivan DA,Schaumberg DA.Impact of dry eye syndrome on vision-related quality of life.Am J of Ophthalmol.2007;143(3):409-415. watching television or movies, shopping, and performing 4. Management and therapy of dry eye disease:report of the management and therapy subcommittee of the international housework (P < .001 for all). In the severe group, there was dry eye workshop (2007).Ocul Surf.2007;5(2):163-178. 5.Yu EY,Leung A,Rao S,Lam DSC.Effect of laser in situ keratomileusis on tear stability.Ophthalmology.2000;107(12):2131-2135. also a significant increase in tear film breakup time for both 6. Asbell PA,Spiegel S.Ophthalmologist perceptions regarding treatment of moderate-to-severe dry eye:results of a physician survey.Eye Contact Lens.2010;36(1):33-38. eyes (P < .005) compared with baseline (Figure 6). 7. The definition and classification of dry eye disease:report of the definition and classification of subcommittee of the internaThese registry study results are consistent with previous tional dry eye workshop (2007).Ocul Surf.2007;5(2):75-92. 8. Høvding G,Aasved H.Slow-release artificial tears (SRAT) in dry eye disease:report of a preliminary clinical trial.Acta research on Lacrisert for the treatment of patients with Ophthalmol.1981;59:842-846. moderate-to-severe dry eye symptoms.9,10 The registry study 9. Breslin C,Katz J,Kaufman H,Katz I.Slow-release artificial tears.Symposium on Ocular Therapy.1977;10:77-83. 10. Katz J,Kaufman H,Breslin C,Katz I.Slow-release artificial tears and the treatment of keratitis sicca.Ophthalmology. shows use of the insert for 4 weeks significantly improves 1978;85:787-793. 11. Lamberts D,Langston D,Chu W.A clinical study of slow-releasing artificial tears.Ophthalmology.1978;85:794-800. symptoms, performance of the activities of daily living, and 12. Werblin T,Rheinstrom S,Kaufman H.The use of slow-release artificial tears in the long-term management of keratitis sicca. Ophthalmology.1981;88(1):78-81. quality of life. An improvement of nearly 30% in OSDI and 13. Hill J.Slow-release artificial tear inserts in the treatment of dry eyes in patients with rheumatoid arthritis.Br J Ophthalmol. other scores for severe dry eye patients suggests that the 1989;73:151-154. 14. Luchs J.Efficacy of hydroxypropyl cellulose ophthalmic inserts (HCOI) in dry eye syndrome (DES) at all levels of severinsert can meaningfully improve the ocular surface for this ity.Poster presented at:The Association for Research in Vision and Ophthalmology Annual Meeting;May 6,2010;Fort Lauderdale,FL. difficult patient group in a relatively short time. SEPTEMBER 2010 ADVANCED OCULAR CARE 39