Oral nutrition is considered primary therapy for dry eyes 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, OSDI, tear break-up time (TBUT), Schirmer’s score, corneal staining and omega index.
This was a multicenter, prospective, interventional, placebo controlled, double masked, randomized trial. On final analysis, 105 patients with dry eyes were randomized to receive four capsules (2 gm) once a day containing 1680 mg EPA and 560 mg 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.
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 Week 6; 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 Week 6; 0.002 Week 12) 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).
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 eyes and results in a statistically significant improvement in tear osmolarity, OSDI, tear break-up time and omega index levels.
Clinical Trial Results
- Significant improvement in tear osmolarity
- Significant improvement in omega-3 index levels
- Significant improvement in OSDI
- Significant improvement in tear break-up time