A Randomized Controlled Study Of Jue-Ming Granules Combined With Artificial Tears In Dry Eye Disease

To evaluate the efficacy and safety of Jue-Ming Granules combined with artificial tears in patients with dry eye disease (DED).

Prospective, single-center randomized controlled clinical study conducted at a tertiary eye care hospital.

Seventy-four patients with DED were enrolled in this prospective, single-blind randomized controlled trial and assigned to an experimental group (n=37) or a control group (n=37). Both groups received 0.1% sodium hyaluronate eye drops for 8 weeks. The experimental group additionally received Jue-Ming Granules. Clinical evaluations included the Ocular Surface Disease Index (OSDI), non-invasive tear breakup time (NITBUT), and symptom scores based on traditional Chinese medicine assessment at baseline and at weeks 2, 4, and 8.

Baseline characteristics and clinical parameters were comparable between groups (P>0.05). After 8 weeks, the experimental group showed significantly greater improvement in OSDI, NITBUT, and symptom scores compared with baseline and the control group (P<0.05). Mean OSDI decreased from 46.57±18.15 to 19.95±10.86, and NITBUT increased from 5.13±2.34 s to 11.07±6.27 s. Improvements in corneal fluorescein staining, visual quality, and corneal sensitivity were also greater in the experimental group. No treatment-related adverse events were observed.

Jue-Ming Granules combined with artificial tears significantly improves symptoms and tear film stability in patients with dry eye disease, demonstrating good clinical efficacy and safety.