Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye
EXOIUMS
A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye Syndrome
2 other identifiers
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 4, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedMay 1, 2025
August 1, 2024
1.4 years
August 4, 2024
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
4, 8 , and 12 weeks
Secondary Outcomes (2)
Tear Secretion Test (Schirmer test)
4, 8 , and 12 weeks
Tear Film Break-up Time
4, 8 , and 12 weeks
Study Arms (1)
Limbal Stem Cell Derived Exosome Eye Drop treatment
EXPERIMENTALPatients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drop intervention for 3 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moheb Kowsar Hospital
Tehran, Iran
Related Publications (1)
Randall Harrell C, Djonov V, Volarevic A, Arsenijevic A, Volarevic V. Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease. J Ophthalmol. 2025 Jan 10;2025:5552374. doi: 10.1155/joph/5552374. eCollection 2025.
PMID: 39839752DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 4, 2024
First Posted
August 9, 2024
Study Start
August 1, 2024
Primary Completion
January 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 1, 2025
Record last verified: 2024-08