Examining the health and effectiveness of using exosomes derived from limbal mesenchymal stem cells in dry eye patients
Design
Clinical trial, parallel groups, blind on one side, phase 3 on 30 patients.
Settings and conduct
In this research, all patients with complaints of burning or itching or feeling of a foreign body in the eye, referred to Rasoul Akram Hospitals in Tehran, will be included in the study. The sample size is 30 people. A total of 40 patients will be examined. Data analyst will be blinded.
Participants/Inclusion and 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 systemic steroid in the last three months, Use of contact lenses in the last three months
Intervention groups
Intervention group: Patients will receive one drop (0.05 cc) of exosome with one drop (0.05 cc) of artificial tears without preservative in the right eye, every 6 hours (4 times a day) for three months.
Control group: Patients will receive one drop (0.05 cc) of artificial tears without preservative in the left eye, every 6 hours (4 times a day) for three months.
Main outcome variables
Dry eye
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231022059814N1
Registration date:2023-11-11, 1402/08/20
Registration timing:prospective
Last update:2023-11-11, 1402/08/20
Update count:0
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
Kian Alirezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
kian.alirezaei.72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the health and effectiveness of using exosomes derived from limbal mesenchymal stem cells in dry eye patients
Public title
The effect of exosomes on dry eye
Purpose
Treatment
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 systemic steroid in the last three months
Use of contact lenses in the last three months
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
In each of the participants, the right eye and the left eye will be examined as 2 samples. The intervention will be done in the right eye and the left eye will be the intervention group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the data based on groups 1 and 2 and will not know the type of treatment provided in the groups and will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-09-12, 1402/06/21
Ethics committee reference number
IR.IUMS.FMD.REC.1402.283
Health conditions studied
1
Description of health condition studied
Dry eye
ICD-10 code
H04.12
ICD-10 code description
Dry eye syndrome
Primary outcomes
1
Description
Dry eye
Timepoint
Before the intervention, 4 and 12 weeks after the intervention
Method of measurement
Based on the ocular surface disease index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with dry eyes, will receive in the right eye, one drop (0.05 cc) of exosome derived from limbal mesenchymal stem cells with a concentration of 0.01 micro liter (produced in the laboratory by the researcher) along with one drop (0.05 cc) artificial tears Advanced 0.15 without preservative containing 150 mg of sodium hyaluronate per 100 ml (manufacturer: Artipic Pharmaceutical Company), every 6 hours (4 times a day) for three months.
Category
Treatment - Drugs
2
Description
Control group: Patients with dry eyes, will receive in the left eye, one drop (0.05 cc) artificial tears Advanced 0.15 without preservative containing 150 mg of sodium hyaluronate per 100 ml (manufacturer: Artipic Pharmaceutical Company), every 6 hours (4 times a day) for three months.