Background: Dry eye disease (DED) is a very common disease. Although several current treatments offer some symptomatic relief, moderate to severe DED is still difficult to cure at present. Acupuncture may be effective for DED via its promotion of tear secretion and ability to improve symptoms, but evidence of its effectiveness is limited. The aim of this study is to evaluate the effect of acupuncture versus artificial tears in moderate to severe DED.
Methods/design: A total of 120 participants with moderate to severe DED will be randomly assigned to either an acupuncture group or an artificial tear group at a ratio of 1:1. Participants in the acupuncture group will undergo treatments on a single BL1 acupuncture point 3 times per week for 8 weeks. Participants in the control group will use artificial tears 4 times per day for 8 weeks. The primary outcome will be the change from baseline in a mean Schirmer-I test (SIT) at week 8. The secondary outcomes will include the visual analog score (VAS) for the improvement of ocular symptoms, the ocular surface disease index (OSDI), the tear film break-up time (TBUT), and corneal fluorescein staining (CFS) at weeks 4, 8, and 32. Acupuncture acceptance will be evaluated at week 8. Adverse events will also be monitored and documented. A follow-up assessment will be conducted 24 weeks after the treatment.
Discussion: We expect to verify that acupuncture is better than artificial tears toward improving the mean SIT values of patients with moderate to severe DED.