Safety and Efficacy of Biodegradable Microneedle Acupuncture for Dry Eye: A Multicenter, Randomized, Active-controlled Pivotal Trial

This clinical trial aimed to assess the safety and efficacy of Biodegradable microneedle acupuncture (BMA) compared to sterile acupuncture (SA) in treating dry eye (DE). A total of 224 participants with DE were randomly assigned in a 1:1 ratio to either the BMA group (BMAG) or the SA group (SAG). Treatment was administered three times per week for four weeks at eight bilateral acupoints (GB14, TE23, EX-HN5, and ST1). The primary outcome was the proportion of participants experiencing at least one treatment-related adverse event (AE) during the 5-week treatment period. Secondary outcomes included changes in the Ocular Surface Disease Index (OSDI), visual analog scale for subjective symptoms (VAS-SS), quality-of-life (QoL) scores, treatment satisfaction, and additional safety assessments. The proportion of participants experiencing treatment-related AEs was significantly lower in the BMAG than in the SAG (risk ratio, 0.17; 95% CI, 0.11–0.28; p < 0.0001).Greater improvements were observed in the BMAG for OSDI (mean difference −16.23; 95% confidence interval [CI], −19.32 to −13.15), VAS-SS (−19.33; 95% CI, −22.00 to −16.66), and QoL (0.96; 95% CI, 0.74–1.19). No skin allergy-related AEs occurred in the BMAG, whereas such events were observed in the SAG. BMA was associated with a lower risk of treatment-related AEs and greater clinical improvement compared with sterile acupuncture in patients with DE. These findings suggest that BMA may represent a safer and more effective therapeutic option for DE management. Clinical Research Information Service, Republic of Korea (KCT0008802). Registered on September 15, 2023.