A Phase 1 interventional study of Limbal Stem Cell Derived Exosomes Eye Drop in Dry Eye Syndromes, sponsored by Iran University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Iran University of Medical Sciences · Phase 1, Interventional, and Treatment
The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Iran University of Medical Sciences is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drop intervention for 3 months.
Biological: Limbal Stem Cell Derived Exosomes Eye Drop
Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drops 0.15 ml/single eye/one time, four times a day for 3 months. The follow-up visit will be 12 weeks since the administration of LSC-Exo eye drops.
Change in Inflammatory and Pro-inflammatory cytokines changes
Dry eye is characterized by ocular surface inflammation. Proinflammatory cytokines IL-1, IL-6, IL-8, TNF-α and IFN-γ are strongly correlated with dry eye markers, leading to ocular surface damage.
Time frame: 12 weeks
Change in Ocular Surface Disease Index (OSDI)
The OSDI questionnaire contains 12 questions to measure dry eye symptoms. OSDI scores range from 0 to 100. The lower the score, the more alleviation of dry eye symptoms. Compared with the baseline, a reduction of more than 10 points indicates improvement
Time frame: 4, 8 , and 12 weeks
Tear Secretion Test (Schirmer test)
A paper strip is placed on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. A positive change from baseline indicates an improvement in each eye.
Time frame: 4, 8 , and 12 weeks
Tear Film Break-up Time
Time required for dry spots to appear on the surface of the eye after blinking was measured in seconds. A positive change from baseline indicates improvement in each eye.
Time frame: 4, 8 , and 12 weeks
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Iran University of Medical Sciences