Objectives: To investigate the efficacy of laser acupuncture (LA) therapy in patients with dry eye disease (DED). Design: A two-center randomized controlled trial. Settings/Location: The Department of Ophthalmology, Chinese Medicine at the Kaohsiung Chang Gung Memorial Hospital, and the Sunming Eye Clinic in South Taiwan. Subjects: Fifty-nine participants ages 20 to 65 years were enrolled and randomly assigned to the experimental group (LA plus conventional treatment) or the sham control group (LA without laser output plus conventional treatment). Interventions: Subjects underwent LA treatment three times a week for 12 weeks. The subjects in the experimental group sequentially received 0.375 J of energy at each of the following acupoints: BL2, TE23, ST2, LI4, ST36, and GB37. Subjects in the control group received a sham LA treatment, without any laser output. Outcome Measures: The primary outcome measure was ocular surface disease index (OSDI). The secondary outcome measures included tear film breakup time (TFBUT), Schirmer-I test finding, and visual analog scale (VAS) score. Results: At 4 and 12 weeks after the first visit, the experimental group showed significant improvement of dry eye symptoms as measured by OSDI, TFBUT, Shirmer-I test, and VAS. Compared with the control group, the OSDI (7.23, p = 0.001) and TFBUT (-1.78, p = 0.001) significantly improved in the experimental group at 12 weeks of treatment. Conclusions: LA improved the symptoms and tear stability related to DED in conjunction with conventional treatment. The authors suggest that LA be considered a complementary therapy for DED when conventional treatment does not provide satisfactory effects. Trial Registration: ClinicalTrials.gov Identifier NCT03204903.

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