Dry eye is among the most prevalent chronic conditions in ophthalmology, significantly
impacting quality of life and presenting a public health challenge that cannot be
overlooked. Current treatment options primarily consist of artificial tear replacement,
anti-inflammatory therapies, and local immunosuppressive treatments, which mainly focus
on alleviating discomfort and other symptoms associated with the ocular surface. However,
with the rapid advancements in regenerative medicine, ophthalmologists are exploring
innovative approaches to treat dry eye. Chronic dry eye can result in corneal damage and
potential vision loss. Recent studies suggest that therapeutic exosomes delivered as eye
drops can enhance the immune microenvironment of the cornea and alter the ocular
surface's microenvironment for better outcomes.
Exosomes are membrane vesicles secreted by parental cells, which can mediate the transfer
of RNA, protein, DNA and other functional molecules of the parent cell between other
cells and regulate the function of target cells. The therapeutic potential of Limbal Stem
Cell Exosomes has been studied by our department. We found that LSC-Exo can alleviate the
symptoms of dry eye in the animal study. At present, we plan to clarify its efficacy in a
clinical research.
The main objective of this study is to evaluate the alleviation of Dry Eye symptoms in
patients which are resist to conventional treatment by tear drops. The assessment will be
done after LSC-Exo treatment by measuring Ocular Surface Index Score (OSDI), and the
second objective include the measurement of inflammatory and pro-inflammatory cytokines
in tear of patients, tear secretion amount, tear break time, the areas stained by
fluorescent, ocular redness, tear meniscus and best corrected visual acuity.
Approximately 30 patients will be recruited. The treatment group will receive artificial
tears for 2 weeks to normalize the baseline, followed by intervention of LSC-Exo
10ug/drop, four times a day for 30 days. The follow-up visit will be 12-weeks and the
progression of dry eye will be measured.