Comparison of Acupuncture Plus Artificial Tears and Artificial Tears Alone in Moderate Dry Eye Disease: A Randomized Controlled Trial

Background and Purpose: Dry eye disease (DED) is a multifactorial disorder associated with ocular discomfort and reduced quality of life. Although artificial tears are widely used, their benefit is often limited, increasing interest in acupuncture as a complementary therapy. This study evaluated the effectiveness of acupuncture combined with artificial tears in moderate dry eye disease using objective clinical measures and patient-reported outcomes. Methods: This prospective randomized controlled trial included 90 patients with moderate dry eye disease [Schirmer 5–10 mm; tear break-up time (tBUT) 6–10 s]. The participants received either artificial tears alone ( n = 46) or artificial tears plus acupuncture ( n = 44). Acupuncture was applied twice weekly for 5 weeks at predefined periocular and systemic acupoints. Schirmer, tBUT, and Ocular Surface Disease Index (OSDI) scores were recorded at baseline (T0), after treatment (T1), and at 1-month follow-up (T2). Results: Both groups improved significantly from baseline ( p < 0.01). At T1, the acupuncture group showed greater gains: Schirmer +2.74 mm (95% CI: 2.08–3.39), tBUT +2.38 s (95% CI: 1.62–3.15), and OSDI −9.28 points (95% CI: −12.39 to −6.17). At T2, acupuncture maintained superiority in tBUT (+1.70 s), while differences in Schirmer and OSDI decreased. Seventeen mild, self-limited adverse events occurred in the acupuncture group. Conclusion: Acupuncture combined with artificial tears resulted in greater short-term improvements in tear production, tear film stability, and symptoms than artificial tears alone in moderate dry eye disease. The continued advantage in tBUT suggests potential sustained benefit. Maintenance sessions may support longer-term improvement. ( ClinicalTrials.gov : NCT07185854.)