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Pilot, Prospective, Randomized, Double-masked, Placebo-controlled Clinical Trial of an Omega-3 Supplement for Dry Eye

Wojtowicz, Jadwiga Cristina MD; Butovich, Igor PhD; Uchiyama, Eduardo MD; Aronowicz, Joel MD; Agee, Shawn MD; McCulley, James P MD, FACS, FRCOphth(UK)

doi: 10.1097/ICO.0b013e3181f22e03
Clinical Science

Purpose: To investigate the potential effect of dietary supplementation with omega-3 fatty acid on lipid composition of meibum, aqueous tear evaporation, and tear volume in patients with dry eye.

Methods: In a pilot, prospective, randomized, double-masked study, patients with dry eye received a daily dose of fish oil, containing 450 mg of eicosapentaenoic acid, 300 mg of docosahexaenoic acid, and 1000 mg of flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) for 90 days. There were 2 patient visits: baseline and final. At these visits, patients completed the ocular surface disease index to score subjective symptoms, and slit-lamp examinations, breakup time, corneal staining, Schirmer type I, fluorophotometry, evaporometry, and collection of meibomian gland secretion samples for lipid composition analysis were performed.

Results: A total of 36 patients with dry eye completed the study. At the end of the study, 70% of the patients became asymptomatic, whereas for the placebo group, 7% of the symptomatic patients became asymptomatic. Schirmer testing and fluorophotometry suggested that the omega-3 supplement increased tear secretion. The lipid composition of the samples collected from the omega-3 group was found to be very similar to that from the placebo group. No trends between groups were seen for other objective parameters.

Conclusions: Dietary supplementation with omega-3 fatty acids in dry eye showed no significant effect in meibum lipid composition or aqueous tear evaporation rate. On the other hand, the average tear production and tear volume was increased in the omega-3 group as indicated by both Schirmer testing and fluorophotometry.

From the Department of Ophthalmology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX.

Received for publication October 23, 2009; revision received April 4, 2010; accepted June 27, 2010.

Supported in part by grants NIH EY12430 and EY016664; an unrestricted grant from the Research to Prevent Blindness, New York, NY; and Advanced Vision Research.

Reprints: James P. McCulley, Department of Ophthalmology, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75390-9057 (e-mail: james.mcculley@utsouthwestern.edu).

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