comparison the effect of blephamed jel with conventional treatment in the anterior blepharitis
Design
simple randomization with 60 patients in two parallel group with 45 days followe up
Settings and conduct
one side blinded two treatment group parallel
Participants/Inclusion and exclusion criteria
inclusion ceritria is ant. blepharitis ; exclusion was medication for blepharitis corneal infection lid abnormality cellulitis or abcess posterior blepharitis without ant. blepharitis dry eye
prior ophthalmic surgery
hordeoulom
pregnancy
lactation
low compliance patient
sensitivity reaction to blephamed
Intervention groups
blephamed group
conventional treatment group
Main outcome variables
lid margin edema erythema debri and patient symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181102041528N1
Registration date:2020-01-18, 1398/10/28
Registration timing:registered_while_recruiting
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Behrouz torabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6621 5071
Email address
doctorbehi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARISON OF THE EFFECT OF CONVENTIONAL TREATMENT VEERSUS BLEPHAMED ON THE SIGN AND SYMPTOMS OF PATIENTS WITH ANTERIOR BLEPHARITIS
SIMPLE RANDOMIZATION: patients after initial evaluation and scoring are devided into two groups by the persumed randomization scale
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are devided into two group by the researcher but the severity of the disease and their response to treatment is evaluated by a blind practitionair
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
iran university of medical sciences
Street address
sattarkhan
City
tehran
Province
Tehran
Postal code
13767-
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
255365
Health conditions studied
1
Description of health condition studied
anterior blepharitis
ICD-10 code
ICD-10 code description
anterior blepharitis
Primary outcomes
1
Description
lid margin debri and crust edema and erythema
Timepoint
first visit then two weeks later then one month later
Method of measurement
slit lamp exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: BLEPHAMED EYE GEL IS USED IN THE EYE LASHES TWICE IN THE DAY FOR 2 WEEKS
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
RASOOL AKRAM HOSPITAL EYE CLINIC
Full name of responsible person
DOCTOR HOSSEIN AGHAEI
Street address
SATTARKHAN BLVD NYAYESH ST
City
TEHRAN
Province
Tehran
Postal code
1373667881
Phone
+98 21 6435 2450
Email
DOCTORBEHI@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
DOCTOR HOSSEIN AGHAEI
Street address
SATTARKHAN AVE
City
TEHRAN
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6434 2450
Email
DOCTORBEHI@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
DOCTOR HOSSEIN AGHAEI
Position
ASSOCIATE PROFESSOR
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
SATTARKHAN AVE.
City
TEHRAN
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2450
Email
DOCTORBEHI@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
DOCTOR HOSSEIN AGHAEI
Position
ASSOCIATE PROFESSOR
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
SATTARKHAN AVE.
City
TEHRAN
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2450
Email
DOCTORBEHI@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
DOCTOR HOSSEIN AGHAEI
Position
ASSOCITE PROFESSOR
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
SATTARKHAN AVE.
City
TEHRAN
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2450
Email
DOCTORBEHI@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
NO MORE DATA
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
STUDY PROTOCOL AND THE REPORT WILL BE AVAILABLE AS THE ARTICLE
When the data will become available and for how long
UNLIMITED
To whom data/document is available
FOR BOTH ACADEMIC AND INDUSTRIAL UNIT WILL BE AVAILABLE WITH REQUEST
Under which criteria data/document could be used
FOR MORE RESEARCH WITH PROPOSAL PAPER
From where data/document is obtainable
IRAN UNIVERSITY EYE RESEARCH CENTER
What processes are involved for a request to access data/document
AFTER REFERRING TO EYE RESEARCH CENTER AND GIVING THE PROPOSAL AND OFFICIAL REQUEST IT WILL REVISED IN THE RESEARCH COUNCIL OF THE OPHTHALMOLOGY GROUP THEN THE DOCMENTS WILL BE AVAILABLE