The comparison efficacy and safety of topical caspofungin ۰.5% and topical voriconazole 1% in fungal keratitis
Design
Two-arm parallel-group randomized trial with blinded patients, randomized group, phase on 20 patients, use randomization table.
Settings and conduct
Patients with unilateral fungal keratitis who have the study's inclusion criteria and do not have any exclusion criteria are enrolled in the study at Farabi Eye Hospital.
Participants/Inclusion and exclusion criteria
1) Fungal keratitis that is confirmed either through a positive sample for corneal smear or culture or through diagnosis by confocal scan.
2) A corneal ulcer with a maximum diameter of 5mm, which involves 4mm of the center of the cornea and extends less than 50% of the stromal depth.
Intervention groups
Patients diagnosed with fungal keratitis will undergo treatment with two different anti-fungal eye drops. In the first group, patients will receive topical voriconazole 1%. The clinical response, effectiveness, and any systemic or localized drop complications will be evaluated. In the second group, patients will receive topical caspofungin 0.5%. The clinical response, effectiveness, and any systemic or localized complications will also be evaluated.
Main outcome variables
Treating fungal corneal ulcers, improving visual acuity, decreasing ocular injection and pain, and controlling corneal infiltration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231219060471N1
Registration date:2024-02-16, 1402/11/27
Registration timing:registered_while_recruiting
Last update:2024-02-16, 1402/11/27
Update count:0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
mehran zarei ghanavati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4261
Email address
m-zareigh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-19, 1402/10/29
Expected recruitment end date
2024-07-09, 1403/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison efficacy and safety of topical caspofungin ۰.5% and topical voriconazole 1% in fungal keratitis
Public title
The comparison efficacy and safety of topical caspofungin ۰.5% and topical voriconazole 1% in fungal keratitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Smear or culture positive fungal keratitis or fungal keratitis with negative smear or culture which is diagnosed by confocal scan
Corneal ulcer with a 5mm maximum diameter, involving 4 mm of the center of the cornea, and extending less than 5۰% of the corneal stromal depth
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
This study uses both block and individual randomization methods, based on random number tables. The samples are divided into two groups (A and B), with 10 randomly selected samples in each group, based on the randomization tables. Additionally, all sequences are randomized.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients participating in this study will be treated by an expert ophthalmologist who will not interfere with their selection process. Patients will be selected randomly based on a randomization table. The main author responsible for evaluating the data will keep blind. Additionally, a data safety and monitoring committee will analyze the study while being blind to the patient's information. All patients will be informed of the study but will not know which medication they are receiving and will remain blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Farabi Eye Hospital, Square Qazvin, South Karegar street
City
Tehran
Province
Tehran
Postal code
1336616351
Approval date
2023-12-04, 1402/09/13
Ethics committee reference number
IR.TUMS.FARABIH.REC.1402.027
Health conditions studied
1
Description of health condition studied
FUNGAL KERATITIS
ICD-10 code
B35-B49,H1
ICD-10 code description
Mycoses, Disorders of sclera, cornea, iris and ciliary body, Disorders of sclera and cornea in diseases classified elsewhere
Primary outcomes
1
Description
The efficacy and safety of topical caspofungin 0.5% and topical voriconazole 1% will be compared in treating fungal keratitis. Clinical response, scar formation, corneal scar size, visual acuity outcomes, and size and depths of corneal infiltration will also be evaluated.
Timepoint
An ophthalmic examination will be conducted daily during hospitalization, on the 7th, 14th, and 30th days, as well as on the 3rd month.
Method of measurement
A clinical examination will be conducted by an expert ophthalmologist. The examination will involve the use of a slit-lamp biomicroscopy to detect clinical response and measure the size and depth of infiltration using a caliper. The size and depth of the corneal scar will also be detected with a slit lamp and measured using a caliper. All clinical responses will be recorded by slit-lamp photography in each examination.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the treatment of fungal keratitis, topical caspofungin 0.5% will be administered. A vial of caspofungin 50 mg is to be diluted with 10.5 cc of Ringer Lactate, and the drops should be instilled every hour for 48 hours. The frequency of administration can then be tapered based on the patient's clinical response. Patients will need to visit the clinic on days 7, 14, and 30 then 3rd month for follow-up appointments.
Category
Treatment - Drugs
2
Description
A control group of patients with fungal keratitis will be treated with topical voriconazole 1%. The voriconazole will be diluted with 20 cc of Ringer lactate. Each patient will receive a drop every hour for 48 hours, after which the dosage will be tapered based on clinical response. Patients will be required to visit the clinic on days 7, 14, 30, and 30 months after the treatment for evaluation of clinical response and to monitor for any clinical and systemic side effects.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Mehran Zarei Ghanavati
Street address
Farabi Eye Hospital, Qazvin Square, South Karegar street
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5542 1080
Email
m-zareigh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehran Zarei Ghanavati
Street address
Farabi Eye Hospital, Qazvin Square, South Karegar street
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5542 1080
Email
m-zareigh@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad taher Rajabi
Street address
Farabi Eye Hospital, Qazvin Square, South Karegar street
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5542 1080
Email
support@doctorrajabi.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mehran Zarei Ghanavati
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Farabi Eye Hospital. Qazvin Square, South Karegar street
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5542 1080
Email
m-zareigh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehran Zarei Ghanavati
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Farabi Eye Hospital. Qazvin square ,South Karegar street
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5542 1080
Email
m-zareigh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehran Zarei Ghanavati
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Farabi Eye Hospital. Qavin Square, South Karegazr street
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5542 1080
Email
m-zareigh@sina.tums.ac.ir
Sharing plan
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all informations
When the data will become available and for how long
dates availability after publication
To whom data/document is available
researchers work at academic centers
Under which criteria data/document could be used
additional similar patients dates
From where data/document is obtainable
corresponding researcher
What processes are involved for a request to access data/document