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Genigraphics® has been producing output from PowerPoint® longer than anyone in the industry; dating back to when we helped Microsoft® design the PowerPoint® software. US and Canada: 1-800-790-4001 Email: info@genigraphics.com [This sidebar area does not print.] Use of High-Dose Omega-3 Fatty Acids to Treat Severe Dry Eyes. Tassos Georgiou*, Despina Nikolaou, Anastasia Neocleous, Soulla Michael, Cristina Ikonomu Ophthalmos Research and Educational Institute. Nicosia, Cyprus * Corresponding author at Ophthalmos Research and Educational Institute. Morfou 48, Engomi, Nicosia, Cyprus. E-mail address: tassosgeorgiou@hotmail.com (Dr. Tassos Georgiou) Introduction The Inflammation Research Foundation, Marblehead, MA, supplied the omega-3 fatty acid concentrates for the study. The omega-3 concentrates consisted of purified ethyl esters rich in EPA (400 mg) and DHA (200 mg) per gram for the liquid formulation. The dosage used in these pilot studies was 10 ml of the liquid formulation providing approximately 3.4 grams of EPA and 1.6 grams of DHA per day. The dosage was divided into two daily doses of 5 ml each. The subject sample included 60 eyes of 30 patients. In the sample there were 26 females and 4 males. Their average age was 58±9.9 years, ranging from 35 to 74 years. These patients who had not responded to other standard treatment for severe dry eyes were supplemented with 10 ml per day of the liquid omega- 3 fatty acid formulation providing 5 grams of EPA and DHA per day. Visual acuity, tear break up time, fluorescein staining of cornea and subjective symptoms were determined at the start, 6 weeks, and 12 weeks after the start of the omega-3 fatty acid supplements. Methods and Materials Our open pilot study indicates that high-dose omega-3 fatty acids (5 grams of EPA and DHA per day) represents a potentially new therapeutic approach for the treatment of severe dry eyes currently not responding to other treatments. There is no cure for severe dry eyes. However since severe dry eye disease appears to be an inflammatory-mediated condition (5), the use of high-dose anti-inflammatory omega-3 fatty acids may offer a potential long-term management approach to this condition. Our working hypothesis is that resolution of inflammation in the eye may be mediated by resolvins, especially those derived from EPA as suggested in animal models (6). The use of high-dose omega-3 fatty acids in the treatment of severe dry eye disease may be able to reduce the number of current anti-inflammatory therapies such as steroids or Restasis eye drops with better patient compliance. The limitations of this preliminary study are (a) the limited number of subjects studied, (b) the lack of a placebo-controlled treatment group, and (c) the lack of measurement of the blood levels of the omega-3 fatty acids and their anti-inflammatory metabolites (resolvins) to correlate with the improvement of the ocular properties. Additional clinical trials to address these limitations are currently in progress. Discussion Dry eye disease is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort and visual disturbance. It impairs quality of life, and it interferes with many ordinary activities such as reading, viewing a computer, screen monitoring and driving a car (1). Estimates of the prevalence of dry eye in the general population range from 5% to 30% at various ages (2,3). Current treatment options for patients with severe dry eye disease have limited efficacy. As a result, patients with severe dry eye disease take nearly five different treatment approaches to manage this condition (4). There is a clear need for additional options to provide continuous relief of severe dry eye disease symptoms and that are acceptable to patients. We hypothesized that high-dose omega-3 fatty acids may provide an alternative treatment. This pilot study was done to support that hypothesis. Results Ophthalmos Research and Educational Institute Prior to the omega-3 fatty acid supplementation, the patients had used a number of previous treatments including: artificial supplements (drops, gel, with or without preservatives), anti-inflammatory steroid drops /ointments / tablets, NSAIDs, Restasis eye drops, and/or punctal plugs. The number of different treatments used by the subjects is shown in Figure 1. Figure 1. Number of different treatment approaches prior to omega-3 supplementation. As shown in Figure 1, 70% of patients used five or more treatment approaches in the previous year before starting on the omega-3 fatty acid supplementation, 22% of patients used four treatments approaches and 8% had used three different treatment approaches. During this pilot study, the subjects used omega-3 fatty acid supplements and artificial tears if needed. During the course of the study, the subjects were analyzed for gains in lines of vision as shown in figure 2. Figure 2 indicates that the eyes that had the greatest gain in vision were those who started with the worse initial vision. The patients who had good initial vision (6/6 or better) were unlikely to improve upon treatment. The patients who had reduced vision (e.g. 6/15 or worse) had a statistically significant (p < 0.05) improvement in vision. The fluorescein staining of the cornea indicates the severity of the epithelial defect on the cornea. Usually the more severe the disease, the more severe the staining. Figure 3: Fluorescein staining score of the cornea Figure 3 illustrates that staining improved significantly from start to the end of the study. At the start of the study, the fluorescein staining was either moderate (17%) or severe (83%) in all patients. By the end of the study, no eye had severe staining, and only one eye had moderate staining. Tear break up time (TBUT) in an index of precorneal tear film stability. It represents the time from blinking to first corneal black spot appearance in the tear film. The result of the omega-3 fatty acid supplements on the TBUT is shown in Figure 4. Figure 4. Tear film beak up time in seconds Figure 4 illustrates that TBUT increased during the 12 weeks of the study. This increase in tear film stability was statistically significant (p < 0.001). Patient assessment of improvement of quality of life during the course of the study is shown in Figure 5. The improvement was rated as 1=minimal or without change ( 50%). The results showed that for all eyes (N=60) there was substantial improvement (>50%) throughout the study. Figure 5: Subjective improvement Figure 5 shows that there is clear improvement of the subjective symptoms of the patients by at least 50% for severe dry eye symptoms within the first 6 weeks of treatment, and this is maintained at 12 weeks. 1. Freidman JN. Impact of dry eye disease and treatment on quality of life. Curr Opin Ophthalmol 2010;21:310-316. 2. Vogel R et at. Demonstration of efficacy in the treatment of dry eye disease with 0.18% Sodium Hyaluronate Ophthalmic solution. Am J Ophthalmol 2010; 149:594-601. 3. Tong L et al. Choice of artificial tear formulation for patients with dry eye: where do we start? Cornea 2012; 31:S32-S36. 4. Asbell AP. Ophthalmologist perceptions regarding treatment of moderate to severe dry eye: Results of a physician survey. Trans Am Ophthalmol Soc 2009; 107:205-213. 5. McCabe E et al. Advancement in anti-inflammatory therapy for dry eye syndrome. Optometry 2009; 80:555-566 6. Li N et al. Resolvin E1 improves tear production and decreases inflammation in dry eye mouse model. J Ocul Pharmacol Ther 2010; 26:431-439 References no of eyes Figure 2: Number of lines gained in 3 months No of eyes 100% seconds