Comparative evaluation of the efficacy of Nano formulation of Tacrolimus and Cyclosporine eye drops in patients with dry eye
Design
A randomized clinical trial was conducted using table of random numbers, double-blind, and parallel group design with 40 patients with dry eye syndrome, followed up for one month.
Settings and conduct
On 40 patients with Sjogren's syndrome referred to the rheumatology clinic, Ocular Surface Disease Index (OSDI)
questionnaire, Schirmer test, Tear film break up time test (TBUT)and Sm-tube and the slit lamp examination in Ophthalmology Clinic Vali Asr done. After confirming dry eye, Tacrolimus and Cyclosporine for use in each eye for one month and every week the examination of possible side effects. The ophthalmologist does not know which drug is used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Sogren's diagnosis and burning symptoms, foreign body sensation and dryness in both eyes, and abnormal Schirmer test or TBUT test.
Exclusion criteria: pregnancy and lactation, patients with any structural disorder, any inflammation in the anterior chamber, glaucoma, previous eye surgery, recent use of topical or systemic antibiotics or anti-inflammatory drugs, contact lenses, corneal infections.
Intervention groups
Tacrolimus drops for one eye and Cyclosporine for other eyes twice a day for one month.
Main outcome variables
Measuring of schirmer test, SM-Tube,TBUT and OSDI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041253N1
Registration date:2019-01-08, 1397/10/18
Registration timing:registered_while_recruiting
Last update:2019-01-08, 1397/10/18
Update count:1
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Mozhgan Ahrary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 8716
Email address
mozhganahrari@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the efficacy of Nano formulation of Tacrolimus and Cyclosporine eye drops in patients with dry eye
Public title
Tacrolimus and Cyclosporine effect in dry eye
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sjögren's syndrome was diagnosed according to the Sjögren's syndrome European Criteria
Chronic symptoms of burning, foreign body sensation,itching in both eyes
Daily need of artificial tears
Abnormal Schirmer test < 5 mm or Tear break-up time (TBUT) < 5 seconds in any eye
Exclusion criteria:
Sensitivity to tacrolimus
Trachoma
Pregnancy and lactation
Other systemic atopic diseases
Previous eye surgery
Any structural abnormalities (lid scarring, entropion, trichiasis, etc.)
Any inflammation in the anterior chamber
Glaucoma
Previous eye Surgery
Use of other topical drugs, especially artificial tears
Use of topical or systemic antibiotics or anti-inflammatory drugs 90 days before entering the study
Contact lens wearers
Corneal infections and any corneal diseases (marginal ulcer, opacity, scar and tumors)
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
We assign patients from code 1 to 40. Then we use table of random numbers to select 20 numbers. For the 20 selected patients, the Tacrolimus drug is used in the right eye and the Cyclosporine drug is used in the left eye. On the other 20 patients in the left eye, we will use Tacrolimus and the right eye we will use the Cyclosporine drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,the ophthalmologist who performs the examination and evaluation of the patients and the person who performs the data analysis is unaware of which drug is used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.BUMS.REC.1397.071
Health conditions studied
1
Description of health condition studied
Dry eye syndrome
ICD-10 code
H04.1
ICD-10 code description
Other disorders of lacrimal gland
Primary outcomes
1
Description
Foreign body sensation
Timepoint
Before intervention and one month after treatment
Method of measurement
Ocular Surface Disease Index (OSDI)
2
Description
Tear film break up time test (TBUT)
Timepoint
Before intervention and one month after treatment
Method of measurement
In seconds, with a timer and slit lamp
3
Description
Production of tears
Timepoint
Before intervention and one month after treatment
Method of measurement
Schirmer's test in millimeters
4
Description
Tear volume measurement (SM Tube)
Timepoint
Before intervention and one month after treatment
Method of measurement
The SM Tube strip is held in the lower lip for 5 seconds. After 5 seconds, the height of the absorbed tear of the blue column is measured.
5
Description
Light sensitivity
Timepoint
Before intervention and one month after treatment
Method of measurement
Ocular Surface Disease Index (OSDI)
6
Description
Blurred vision
Timepoint
Before intervention and one month after treatment
Method of measurement
Ocular Surface Disease Index (OSDI)
7
Description
Eye irritation
Timepoint
Before intervention and one month after treatment
Method of measurement
Ocular Surface Disease Index (OSDI)
Secondary outcomes
empty
Intervention groups
1
Description
International group 1: 0.05% nano formulation Tacrolimus drop produced at the Abu Reyhan Pharmacy Company for one eye twice a day, One drop use in the lower conjunctiva for one month.
Category
Treatment - Drugs
2
Description
International group 2: Cyclosporine drop Sinadarou Company uses a drop in the lower conjunctiva for one month twice a day for another eye.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Vali Asr Hospital
Full name of responsible person
Mozhgan Ahrary
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3244 3000
Email
mozhganahrarii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
toba kazemi
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mozhgan Ahrary
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3244 5402
Email
mozhganahrarii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Malihe Nikandish
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cornea and anterior segment
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3244 5402
Email
malihenikandish@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mozhgan Ahrary
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3244 5402
Email
mozhganahrarii@gmail.com
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