Study of Limbal Stem Cell Derived Exosome Eye Drops for Treating Moderate to Severe Dry Eye Evaluating Safety and Symptom Relief in Adults Aged 18 to 70

What this Trial Is About

Dry eye syndrome is a common chronic eye condition that can significantly affect quality of life and may lead to corneal damage or vision loss. Researchers are evaluating the safety and effectiveness of Limbal Stem Cell derived Exosomes LSC-Exo as eye drops to relieve symptoms in patients who have not responded well to conventional treatments. This study is a Phase 1 clinical trial aiming to assess improvements in dry eye symptoms and related inflammation. Participants will first use artificial tears for 2 weeks to establish a baseline. Then, they will receive LSC-Exo eye drops at a dose of 10 micrograms per drop, applied four times daily for 30 days. After treatment, patients will be followed for 12 weeks to monitor progress. The study involves only one treatment group receiving the investigational eye drops following the initial artificial tear phase. During the study, participants will have assessments including the Ocular Surface Disease Index OSDI score at 4, 8, and 12 weeks, measurement of inflammatory and pro-inflammatory cytokines in tears, tear secretion tests, tear film break-up time, ocular redness, and visual acuity tests. These evaluations will help determine changes in dry eye severity and eye surface health. The total participation duration is approximately 12 weeks after starting the LSC-Exo treatment.

Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye