Eye drops made from Limbal Stem Cell Exosomes for treating dry eye
A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye Syndrome
This study is testing new eye drops made from stem cell exosomes to see if they can help people with dry eye who haven't found relief from other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Iran University of Medical Sciences Academic / other |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06543667 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of eye drops derived from Limbal Stem Cell Exosomes (LSC-Exo) in alleviating symptoms of dry eye syndrome. Dry eye is a common chronic condition that significantly affects patients' quality of life, and current treatments often provide limited relief. The study will focus on patients who have not responded well to conventional treatments, assessing the impact of LSC-Exo on their symptoms. By utilizing exosomes, which are known to enhance the immune microenvironment of the cornea, the study seeks to provide a novel therapeutic approach to managing dry eye.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with moderate to severe dry eye symptoms who have not found relief from standard treatments.
Not a fit: Patients with a history of eye surgery, immune system suppression, or certain other eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer significant relief for patients suffering from chronic dry eye who have not benefited from existing therapies.
How similar studies have performed: While the use of exosomes in ophthalmology is a relatively novel approach, preliminary animal studies have shown promising results in alleviating dry eye symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with complaints of burning or itching or feeling of a foreign body in the eye * Moderate and severe dry eye severity * Age between 18-70 years Exclusion Criteria: * Previous history of eye surgery * Any disease that suppresses the immune system * Pregnancy and breastfeeding * Eyelid abnormalities * Use of eye drops in the past year except artificial tears and lubricating ointments * Use of systemic drugs that affect the tear film in last three months * Use of contact lenses in the last three months
Where this trial is running
Tehran
- Moheb Kowsar Hospital — Tehran, Iran (Recruiting)
Study contacts
- Study coordinator: Hossein Aghaei, MD
- Email: draghaei.h@gmail.com
- Phone: +982155661188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.