Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye
ConditionDry Eye Syndromes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIran University of Medical Sciences
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous history of eye surgery
Any disease that suppresses the immune system
Pregnancy and breastfeeding
Eyelid abnormalities
Trial design
Design model
Single group
Treatments tested in this trial
Limbal Stem Cell Derived Exosomes Eye Drop
Biological/VaccinePatients 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Limbal Stem Cell Derived Exosome Eye Drop treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
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 weeksSponsors and contacts
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Source ClinicalTrials.gov