Effect of Oral Re-Esterified Omega-3 Nutritional Supplementation on Dry-Eye Disease: Double-Masked Randomized Placebo-Controlled Study

Donnenfeld, Eric

Effect of Oral Re-Esterified Omega-3 Nutritional Supplementation on Dry-Eye Disease: Double-Masked Randomized Placebo-Controlled Study

Sunday, April 19, 2015: 8:01 AM

Room 1B (San Diego Convention Center)

Eric D. Donnenfeld, MD

Edward J. Holland, MD

Frank A. Bucci Jr, MD

Alice T. Epitropoulos, MD, FACS

Cynthia Matossian, MD, FACS

Melissa M. Toyos, MD

Stephen S. Lane, MD

William J. Faulkner, MD

Purpose
Oral nutrition is considered primary therapy for dry eye disease and meibomian gland dysfunction. The purpose of this study was to assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, MMP-9, ocular surface disease Index (OSDI), tear break-up time (TBUT), Schirmer's score, corneal staining and omega Index.

Methods
This was a multicenter, prospective, interventional, placebo controlled, double masked, randomized trial. On Final analysis, 105 patients with dry eye disease were randomized to receive four capsules (2 gm) once a day containing 1680mg EPA and 560mg DHA (PRN Dry Eye Omega Benefits) for 3 months or four capsules of placebo. All patients underwent a screening, baseline, 6 week and 12 weeks visit. On each visit patients were tested for tear osmolarity, MMP-9, fluorescein corneal staining, Schirmer’s testing, and OSDI. On the screening exam and week 12 evaluation patients had their omega index tested.

Results
Mean tear osmolarity at baseline, week 6 and week 12 was 326.0+15.4, 317.0+20.5 and 317.7+19.7 mOsm/L for the placebo group versus 326.2+15.8, 309.4+13.4, 306.9+12.1 mOsm/L for the omega-3 group (P=0.042 Week6; 0.004 Week 12) OSDI placebo group at baseline, week 6 and 12 was, 27.1± 22.9, 19.6 ±17.0, and 22.0+19.3 compared to 32.4±19.2, 21±14.4, and 15.5+11.0 for the omega group. (P=0.285 Week6; 0.002 Week12) Tear Break up Time placebo group at baseline, week 6 and 12 was 4.61±2.04, 5.55±2.43 and 5.81+3.13 compared to 4.78± 2.96, 6.64 ± 3.17 and 8.25+4.78 for the omega group. (P=0.126 Week 6; 0.002 Week 12) Omega Index levels statistically improved at 12 weeks in the omega group vs placebo (p<0.001).

Conclusion
This study demonstrated that oral consumption of re-esterified omega-3 fatty acids (1680 mg EPA and 560 mg DHA once daily for 12 weeks) is an effective treatment of dry eye disease and results in a statistically significant improvement in tear osmolarity, OSDI, tear break up time and omega index levels.