n−3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease

Abstract

BACKGROUND Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n–3 fatty acids (often called omega-3 fatty acids) to relieve symptoms. METHODS In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n–3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer’s test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs. RESULTS A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (−13.9 points and −12.5 points, respectively; mean difference in change after imputation of missing data, −1.9 points; 95% confidence interval [CI], −5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, −0.2 to 0.1), corneal staining score (0.1 point; 95% CI, −0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, −0.1 to 0.5), and result on Schirmer’s test (0.0 mm; 95% CI, −0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n–3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups. CONCLUSIONS Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n–3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763.)

<p>Comparison of the iLUX and the LipiFlow for the Treatment of Meibomian Gland Dysfunction and Symptoms: A Randomized Clinical Trial</p>

“…The Dry Eye Assessment and Management (DREAM) Study Research Group randomized 535 patients to a daily oral dose of 3000 mg of fish-derived n-3 fatty acids or an olive oil placebo. 26 OSDI scores at 12 months improved significantly in both groups, by 13.9 and 12.5 points, respectively, but did not differ significantly in these two groups. Patients in the DREAM study were required to have OSDI scores of 25-80 at screening and 21-80 at eligibility confirmation.…”

“…This study enrolled and randomized 142 subjects, consisting of 101 women and 41 men aged 19-86 years (mean age, 54.9 ± 15.3 years); the sex ratio is typical of patients with dry eye, with a ratio of women to men ranging from 2:1 to 3:1. 16,19,26 Most subjects (90.8%) were white. Seventy-one subjects were treated with the iLUX and 70 with the LipiFlow.…”

Climatic and Environmental Correlates of Dry Eye Disease Severity: A Report From the Dry Eye Assessment and Management (DREAM) Study

“…Details regarding study methodology, inclusion and exclusion criteria, definition of DED, and main results have been previously published. 17 Participants included adults with ocular dryness for at least 6 consecutive months who had moderate to severe symptoms (score 25–80) as measured by the OSDI questionnaire, a tool ranging from 0 to 100 with a higher score indicative of more severe DED symptoms. 18 , 19 In addition, patient eligibility criteria required two of the following signs of DED in at least one eye during both screening and confirmation of eligibility visits: conjunctival lissamine green staining ≥1 (0–6 scale), corneal fluorescein staining ≥4 (0–15 scale), tear breakup time (TBUT) ≤7 seconds, and a 5-minute anesthetized Schirmer's test between 1 and 7 mm.…”

Modern approach to the treatment of dry eye, a complex multifactorial disease: a P.I.C.A.S.S.O. board review

“…67 However, in a recent multicenter, double-masked clinical trial where moderate-to-severe DED patients were randomised to receive for 1 year, either a daily oral dose of EPA and DHA (treatment group) or olive oil (placebo group), there were no significant differences between the two groups for both the signs and symptoms of DED. 69 Other molecules, including cyclosporine A, tacrolimus and lifitegrast act by inhibiting lymphocyte migration to the ocular surface but require a longer period compared to corticosteroids before they become effective in controlling inflammation. 35-38 65 The correct use of tear substitutes can play an important role in helping to achieve the control of the inflammatory process on the ocular surface: they improve tear fluid clearance and reduce the concentration of pro-inflammatory agents.…”