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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
Introduction
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
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.
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
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 (<25%), 2=moderate (25-50%), or 3=substantial improvement (>50%).
The results showed that for all eyes (N=60) there was substantial improvement
(>50%) throughout the study.
Figure 5: Subjective improvement
100%
100%
60
no of
eyes
50
Minimal/no change (<25%)
40
Moderate change (25%-50%)
Substantial improvement (>50%)
30
20
10
0
0
0
0
0
1
Figure 1. Number of different treatment approaches prior to omega-3 supplementation.
Methods and Materials
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 omega3 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.
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.
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
During the course of the study, the subjects were analyzed for gains
in lines of vision as shown in figure 2.
seconds
No of
eyes
Figure 2: Number of lines gained in 3 months
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.
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).
2
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.
Discussion
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.
References
* Corresponding author at Ophthalmos Research and Educational Institute.
Morfou 48, Engomi, Nicosia, Cyprus.
E-mail address: [email protected] (Dr. Tassos Georgiou)
Ophthalmos Research and
Educational Institute
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