Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease.
Carl Randall Harrell, Valentin Djonov, Ana Volarevic...
https://pubmed.ncbi.nlm.nih.gov/39839752Actively Recruiting
Phase 1
Age: 18Years - 70Years
All Genders
ID06543667
A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome Eye Drop for Treatment of Dry Eye Syndrome
Led by Iran University of Medical Sciences · Updated on 2025-05-01
30
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 2 weeks
Participants use artificial tears for 2 weeks to normalize their baseline condition before starting the study treatment.
1 visit (in-person)
Treatment
Duration - 30 days
Participants receive Limbal Stem Cell Derived Exosome eye drops, applying 0.15 ml per eye four times a day for 30 days to treat dry eye symptoms.
Visits at 4 and 8 weeks for assessments
Follow-up
Duration - 12 weeks
Participants are monitored for an additional 12 weeks to assess the progression of dry eye and treatment effects.
1 visit (in-person) at 12 weeks
Trial Site Locations
Total: 1 location
1
Moheb Kowsar Hospital
Tehran, Iran
Actively Recruiting
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Research Team
H
Hossein Aghaei, MD
A
Alireza Shoae-Hassani
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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