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अमूर्त

A Combined Regimen of Dietary Supplements Containing Omega-3 Fish Oil and Standardized Maqui Berry Extract Improves Dry Eye Related Symptoms in a Pilot Randomized Interventional Clinical Study

Edward L Paul Jr, Anisha Patel and Sailaja Machiraju

Purpose: To determine if a dietary supplement consisting of a re-esterified triglyceride form of omega-3 fish oil combined with a standardized maqui berry extract is more efficacious for the treatment of dry eye disease than omega-3 fish oil alone.

Methods: This was an institutional review board-approved, single-site, randomized, interventional, placebocontrolled, comparative, pilot clinical study. Patients with mild to moderate dry eye disease (DED) were enrolled and divided into four study groups. Group 1 (O3M) received dietary supplements of a re-esterified triglyceride form of omega-3 fish oil (O3) and a standardized maqui berry extract (M); group 2 (O3) received only the omega-3 supplements; group 3 (M) received only the maqui berry extract supplements; and group 4 received placebo capsules. Thirteen participants aged 26–78 years with DED were included. Patients were evaluated for DED by corneal staining, changes in tear osmolarity values, matrix metalloproteinase-9 (MMP-9) levels, Schirmer's test, and tear breakup time (TBUT) at baseline, week 2, week 4, week 8, and a final assessment at week 12. In addition, at each visit patients were given the Ocular Surface Disease Index (OSDI) and Dry Eye questionnaires to complete in order to assess their level of DED. Adverse events (AEs) were recorded on AE forms at each patient visit, and any serious AEs were to be reported to the sponsor within 24 hours via telephone.

Results: 13 patients participated in the study (77% females, 23% males), with an average age of 55 years. The highest average percent improvement in OSDI & DED scores from baseline through week 12 of study treatment was demonstrated in the O3M group (77.6% and 70.5% respectively), compared to 39.2% improvement in OSDI assessment and 44.9% in DED score for the O3 group. Schirmer's tests demonstrated an average increase in tear production over baseline of ~3.4 mm in OD and ~0.8 mm in OS after 3 months for the O3M group. In comparison, for the O3 group, the tear production decreased by ~0.6 mm in OD and increased by ~1.67 mm in OS from baseline to 3 months. TBUT improved significantly in the O3M group, from baseline to 3 months it went up by ~3.2-2.8 sec in both eyes (OD & OS), while for the O3 group TBUT values went up by ~1.66-2.0 sec in both eyes (OD&OS). Notably, there were no adverse events reported due to dietary supplement usage during the study.

Conclusion: Dietary supplements of omega-3 fish oil and standardized maqui berry extract outperformed omega-3 fish oil alone as a treatment for DED.