Journal Article
Multicenter Study
Randomized Controlled Trial
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A Randomized Controlled Trial of Omega 3 Fatty Acids in Rosacea Patients with Dry Eye Symptoms.

Objective or purpose: To evaluate the efficacy of dietary omega-3 fatty acids (O3FAs) in rosacea patients having dry eye symptoms.

METHODS: A prospective, interventional, randomized, double-masked, placebo-controlled, multi-centric study was done. Symptomatic patients with rosacea were recruited based on their response to (Dry Eye Scoring System, DESS©); a score of 0-3 was assigned to dry eye-related symptoms like ocular fatigue, blurring of vision, itching or burning, sandy or gritty sensation, and redness, respectively (DESS©). Subjects were (n = 130) were randomized to receive either O3FAs (n = 65) or placebo (n = 65) capsules (olive oil) twice daily for 6 months. Patients were evaluated at baseline, 1, 3, and 6 months. Change in subjective dry eye symptoms was the primary outcome measure. Change in meibomian gland score (MGS), Schirmer score, and tear film breakup time (TBUT) were the secondary outcome measures.

RESULTS: Repeated-measures ANOVA revealed that there was a significant (p < 0.001) change in symptoms (F(1.506, 88.825 = 315.193), MGS (F(1.336, 78.796 = 84.438), Schirmer score (F(1.322, 78.022 = 86.559), and TBUT (F(1.354, 79.898 = 179.020.559) in O3FA group as compared to placebo group. Post-hoc test revealed that there was a significant change in dry eye symptoms at all points of time; there was a significant change in MGS, Schirmer score, and TBUT also, but only after 3 months of intervention. Linear regression established that symptom severity could significantly predict MGS, Schirmer score, and TBUT. There was a significant change in the slope (intercept) of the regression plots in O3FA group as compared to the placebo group.

CONCLUSION: Rosacea patients with dry eye symptoms have significant improvement in symptoms, MGS, TBUT, and Schirmer score, following dietary intervention with O3FAs for 6 months.

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