1- Comparison of the healing of corneal ulcer scars before and after the administration of losartan drops in the control and intervention groups, 2- Comparison of the healing of corneal ulcer scars before and after the administration of losartan drops between the two control and intervention groups 3- Comparison of the scar changes caused by of corneal ulcer before and after the intervention in two intervention and control groups
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3on 64patients will be done. www.sealedenvelope.com was used for randomization
Settings and conduct
Patients with scars caused by corneal ulcers referring to Khatam Al Anbia Ophthalmology Hospital will participate in the study. All patients will undergo complete ophthalmological examinations.If there is a scar other than a scar caused by an infectious corneal ulcer,the patients will be included in the study The data of the two groups will be analyzed statistically
Participants/Inclusion and exclusion criteria
1. Three to six months have passed since the healing of the corneal ulcer due to the corneal ulcer and the scar remains
2. Definitive diagnosis of corneal scar based on the opinion of a corneal specialist with examination by slit lamp and fluorescent staining
3. The age of patients should be between 18 and 64 year
Exclusion conditions
1. Incidence of allergy caused by losartan drops
2. Corneal scar caused by causes other than corneal ulcer
Intervention groups
The research will be conducted on64patients with scars caused by corneal ulcers referred to Khatam Al Anbia Eye Hospital in two control and intervention groups. The number of patients in each control and intervention group will be 32. Patients in the intervention group will receive losartan drops. The control group will also receive routine care.
Main outcome variables
Corneal ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241102063569N1
Registration date:2024-11-04, 1403/08/14
Registration timing:prospective
Last update:2024-11-04, 1403/08/14
Update count:0
Registration date
2024-11-04, 1403/08/14
Registrant information
Name
Mohammadreza Same'
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 1111
Email address
mrsame1374@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-16, 1403/08/26
Expected recruitment end date
2026-11-10, 1405/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of losartan drops on the healing of scars caused by corneal ulcers
Public title
The effect of losartan drops on the healing of scars caused by corneal ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Written informed consent to participate in the research,
2. Three to six months have passed since the healing of the corneal ulcer due to the corneal ulcer and the scar remains
3. Definite diagnosis of corneal scar based on the opinion of a corneal specialist with examination by slit lamp and fluorescent staining.
. Not having any underlying diseases that require continuous medication
5. The age of patients should be between 18 and 64 years
Exclusion criteria:
1. Allergy caused by losartan drops.
2. Corneal scar due to causes other than corneal ulcer
3. Unwillingness to participate in the intervention or unwillingness to continue the intervention
4. Absence of drug and alcohol addiction
5. Non-use of drugs that suppress the immune system
6. Lack of patient follow-up
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the random block method will be used for randomization. These blocks include blocks of 4, 6, and 8, which have an equal number of each group in each block (for example, in a block of 6, 3 patients will be in the control group and 3 patients will be in the intervention group). This method creates a balance in the number of patients assigned to each of the intervention and control groups. Random sequence generation will be done using www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment will be done using envelopes in the package. The sequences will be placed in sealed envelopes in the same order as they were produced by a person who is not in the course of the study, in such a way that the contents of the envelopes cannot be seen from the outside. The envelopes will be numbered and arranged in order. Then, for each patient entered into the study, an envelope will be opened (in the order of the generated sequence) and based on the content of the envelope, they will be entered into one of the two control or intervention groups. All stages of sequence generation and allocation of patients to groups and concealment of allocation will be done by someone who is not in the course of the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Razavi Khorasan, University St., Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Approval date
2024-08-27, 1403/06/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1403.237
Health conditions studied
1
Description of health condition studied
Corneal ulcer
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer
Primary outcomes
1
Description
The size of the corneal ulcer obtained from complete ophthalmological examinations (including examination with slit lamp, tonometry, imaging with corneal topography, pentacam, oct cornea, aberrometry, slit photo
Timepoint
The size of the corneal ulcer will be measured before the intervention, at the end of the intervention, i.e. three months after using the drops and six months after the intervention.
Method of measurement
The size of the corneal ulcer obtained from complete ophthalmological examinations (including examination with slit lamp, tonometry, imaging with corneal topography, pentacam, oct cornea, aberrometry, slit photo
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with corneal scarring (definitive diagnosis based on the opinion of a cornea specialist with slit lamp examination and fluorescent staining) will participate in the study in two groups: routine treatment (control group) and treatment with losartan drops (intervention group). All patients will undergo complete ophthalmological examinations (including examination with slit lamp, tonometry, slit photo, imaging with corneal topography, pentacam, corneal oct, corneal aberrometry). At the beginning and end of the study, the size and depth of the corneal scar will be measured. Also, the area of corneal ulcer will be measured by slit photo and corneal ulcer smear will be taken from all research units Two groups will be subjected to statistical analysis. The patients in the intervention group will be treated with losartan drops 0.8 mg per day for 3 months The face is aseptic Preparation of the base solution In this step, the base solution is prepared from the required raw materials with precise composition and measurement, then the active pharmaceutical ingredient (API) which is the losartan drug in the form of 0.8 mg of pure losartan potassium powder in 1 ml (Bristol-Myers Squibb) 0.9% sodium chloride is added to the base solution. After adding the active ingredient, the solution is carefully mixed so that all the ingredients inside it are well distributed.As a pre-formulation to investigate clinical effects, this product is made in normal saline solution, so there will be no problem in terms of osmolality and pH. A solution of 0.8 mg/ml of losartan potassium has an osmolarity of about 30. Therefore, its dissolution in 0.9% normal saline solution will not have a significant effect on changing its osmotic pressure. In the same way, the pH of the above solution is acceptable to the eye (pH=7.1).- For stability, the stability test for a period of three months in the refrigerator has already been done to ensure the stability of the product during the period of use. These studies show that the stability of the drug has been maintained during this period and its amount has reached 98% of the initial value with SD=2, which is considered stable for clinical studies during this period.Also, the final solution is cleaned to remove foreign particles and possible contamination. Finally, to disinfect and maintain the consistency of the produced solution, it is disinfected to prevent the growth of microorganisms.The size of the eye drop will be 10 cc and it will be prepared under sterile conditions. Manufacturing and filtration of 0.22 micron in Class C and filling will be done in sterile and aseptic conditions in Class B clean room.Also, it is ensured that the produced solution is compatible with the surface of the eye and usable for patients.
Category
Treatment - Drugs
2
Description
Control group: Control group: Patients with corneal scarring (definitive diagnosis based on the opinion of a corneal specialist with examination by slit lamp and fluorescent staining) will participate in the study in two groups: routine treatment (control group) and treatment with losartan drops (intervention group). did All patients will undergo complete ophthalmological examinations (including examination with slit lamp, tonometry, slit photo, imaging with corneal topography, pentacam, corneal oct, corneal aberrometry). At the beginning and end of the study, the size and depth of the corneal scar will be measured. Also, the area of the corneal ulcer will be measured with a slit photo and a corneal ulcer smear will be taken from all research units Infectious corneal ulcers will not be included in the study.The data of the two groups will be analyzed.Patients in the control group will receive routine care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Eye Hospital
Full name of responsible person
Dr. Javad Sadeghi Allahabadi
Street address
Khorasan Razavi, Mashhad ,Shahid Sepahbad Qarani Blvd.,41 corner of Qarani,
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٩۵٩۶۵٩١٩
Phone
+98 51 3728 1401
Email
kh.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Khorasan, Razavi, Mashhad, University St., next to Hoize Cinema, Qurashi Building, Research and Technology Vice-Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data related to the study will be published in the form of scientific research articles in reputable scientific journals
When the data will become available and for how long
The publication date of the articles will coincide with the end of the study in 2026
To whom data/document is available
All researchers in the field of ophthalmology
Under which criteria data/document could be used
The data of the present study will be used as a scientific text of ophthalmology
From where data/document is obtainable
Reputable scientific journal/corresponding author
What processes are involved for a request to access data/document
The data related to the study will be published in the form of a scientific research article in a reputable scientific journal after the end of the intervention
The corresponding author will respond to questions via email correspondence