A Randomized, Double-Blind, Placebo-Controlled Clinical Trial: Effect of Streptococcus thermophilus iHA318 on Relieving Dry Eye Syndrome and Eye Discomfort
Objective
Dry Eye Syndrome is prevalent worldwide. Unfortunately, artificial tears can only relieve the symptom temporarily and possibly cause adverse effects in long-term usage. To propose a better solution, a large-scale clinical trial was conducted to assess the effect of probiotic iHA318 in relieving dry eye.
Method
A double-blind clinical trial with 80 participants in a 35-day duration was conducted. Tear secretion, tear osmolality, and cell impression cytology were measured on day 0 and day 35. The Ocular Surface Disease Index (OSDI) was used to monitor the degree of discomfort.
Results
iHA318 produces massive amounts of hyaluronic acid and sialic acid in vitro. In the animal study, iHA318 shows abilities to enhance tear secretion, tear film stability, and protect the eyes from UVB damage. In the human clinical trial, tear secretion is significantly increased, and tear osmolality is significantly decreased compared to the placebo group after 35 days of consumption of iHA318. Epithelial cells from the cornea and conjunctiva are collected and then stained with specific dyes. The results indicate that iHA318 can promote goblet cell proliferation and inhibit corneal cell inflammation. These results align with the OSDI data; participants show a significant reduction in OSDI scores, indicating that iHA318 can notably improve eye discomfort and Dry Eye Syndrome.
Conclusions
Our study indicates that iHA318 is the first probiotic with the efficacies of improving Dry Eye Syndrome, protecting the cornea from damage, and alleviating eye discomfort.
References
IRB registration number: 202300014B0
Review board: Institutional Review Board of Jen-Ai Hospital