Investigating the efficacy of insert nanofibers containing Vancomycin and Amikacin in patients with infectious keratitis: A phase I randomized clinical trial (RCT) study
Investigating the efficacy of insert nanofibers containing Vancomycin and Amikacin in patients with infectious keratitis
Design
This is a randomized clinical trial with a parallel design. This non-blinded study will be conducted on 12 patients with infectious corneal ulcers. A table of random numbers is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Imam Khomeini Hospital in Kermanshah, is not blinded. Before starting the treatment, eye symptoms such as pain, redness, photophobia, watery eye discharge, and foreign body sensations are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age above 18 years; Bacterial corneal ulcer with high clinical suspicion; Wound size greater than 2 mm; BCVA greater than 200/20 in the uninvolved eye
Exclusion criteria: Patients with uncontrolled diabetes; Corneal perforation or it's imminent; Symptoms of inflammation in both eyes; History of glaucoma shunt or filtering surgery; Pregnant or lactating women; History of corneal surgery due to refractive errors
Intervention groups
In the intervention group, after dropping a 0.5% tetracaine drop (Sinadaro, Tehran, Iran) in the eye with a corneal ulcer, a nanofiber containing vancomycin-amikacin is placed in the lower fornix of the eye with an infected corneal ulcer, and immediately a drop of Artipic Advanced Artificial Tears 0.15% (Iran Injection and Pharmaceutical Products Company, Tehran, Iran) is poured into the same eye.
The control group will be treated with the standard treatment of Fort Vancomycin (50 mg/ml) and one drop of Fort Amikacin (20 mg/ml).
Main outcome variables
Reducing the healing time of corneal wounds
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N216
Registration date:2024-05-10, 1403/02/21
Registration timing:prospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of insert nanofibers containing Vancomycin and Amikacin in patients with infectious keratitis: A phase I randomized clinical trial (RCT) study
Public title
Investigating the efficacy of insert nanofibers containing Vancomycin and Amikacin in patients with infectious keratitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Bacterial corneal ulcer with high clinical suspicion
Wound size greater than 2 mm
BCVA greater than 200/20 in the uninvolved eye
Exclusion criteria:
Patients with uncontrolled diabetes
Corneal perforation or its imminent
Symptoms of inflammation in both eyes
History of glaucoma shunt or filtering surgery
Pregnant or lactating women
History of corneal surgery due to refractive errors
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-04-23, 1403/02/04
Ethics committee reference number
IR.KUMS.REC.1403.001
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
Reducing the healing time of corneal wounds
Timepoint
every 2 hours on days 3 to 6, every 2 hours when waking up on days 7 to 9, every 6 hours on day 9 and continue treatment until the wound heals
Method of measurement
Based on slit lamp examination with corneal fluorescein staining
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after dropping a 0.5% tetracaine drop (Sinadaro, Tehran, Iran) in the eye with a corneal ulcer, a nanofiber containing vancomycin-amikacin is placed in the lower fornix of the eye with an infected corneal ulcer, and immediately a drop of Artipic Advanced Artificial Tears 0.15% (Iran Injection and Pharmaceutical Products Company, Tehran, Iran) is poured into the same eye.
Category
Treatment - Drugs
2
Description
The control group will be treated with the standard treatment of Fort Vancomycin (50 mg/ml) and one drop of Fort Amikacin (20 mg/ml).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Shahla Mirzaeei
Street address
Naghliyeh Street, Imam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
67187 43161
Phone
+98 83 3728 3602
Email
smirzaeei@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shahla Mirzaeei
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Nurse Blvd., Faculty of Pharmacy
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
smirzaeei@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shahla Mirzaeei
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Nurse Blvd., Faculty of Pharmacy
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
smirzaeei@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shahlaeei
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Nurse Blvd., Faculty of Pharmacy
City
kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
smirzaeei@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD