Efficacy of Terpinen-4-ol Combined With Eyelid Deep Cleaning for the Treatment of Demodex Blepharitis: A Randomized, Open-Label Trial.

Purpose: We aimed to evaluate the clinical efficacy of a combined treatment regimen involving terpinen-4-ol (T4O) and eyelid deep cleaning for managing Demodex blepharitis. Methods: In this randomized, open-label trial, 40 patients diagnosed with Demodex blepharitis at the Cornea Specialty Clinic of Hankou Aier Eye Hospital were enrolled. Participants were randomly assigned to either a T4O or a combination treatment group. The T4O group used T4O cleaning wipes exclusively for two months. The combination group used T4O cleaning wipes and underwent deep eyelid cleaning at three scheduled visits (initial, first-, and second-month time points). A final follow-up was conducted one month after completion of treatment (three months after the beginning of treatment). At each visit, we assessed the number of Demodex mites, the ocular surface disease index (OSDI), eyelid margin sign scores, and corneal fluorescein staining scores. Results: After two months of treatment, both the T4O and combination groups exhibited significant reductions in Demodex mite counts of 5.65 ± 6.03 and 7.75 ± 6.91, respectively. The T4O group, however, showed an increase in mite counts one month after ceasing treatment. Conversely, the combination group maintained and enhanced the reduction in mite counts post-treatment, with a significant difference at the third-month follow-up (8.70 ± 6.81 vs. 4.15 ± 6.91, P = 0.043). Although both groups demonstrated overall declines in OSDI scores post-treatment, only the combination group showed significant improvements at the second- and third-month follow-ups. No adverse events were reported in either group. Conclusions: Treatment with T4O wipes for two months significantly reduces Demodex mite counts, although there is a notable risk of mite rebound when treatment is ceased. Combining T4O wipes and eyelid deep cleaning offers a more effective reduction in Demodex mite counts and improvement in ocular symptoms compared to T4O treatment alone. Translational Relevance: The study finds that T4O combined with eyelid deep cleaning is more effective in treating Demodex blepharitis, highlighting the need for appropriate treatment duration and adjunctive therapies.