Aim: The aim of this study is to evaluation the Effect of tacrolymus on chronic allergic conjunctivitis. This study is a randomized block, single blind design and is in Phase II clinical trial. Inclusion criteria is Allergic conjunctivitis and Exclusion criterias are Blepharitis, Follicular blepharitis, Iritis, Eye infection and Evidence of herpes infection in the past. 126 patients will be studied. In first group patient will receive standard treatment that consist of topical mast cell stabilizer, corticosteroid and NSAID. In second group tacrolimus will be added to standard treatment. Primary outcomes are decrease pruritus, erythema, pain and Foreign body sensation in the eye.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409248410N3
Registration date:2014-10-08, 1393/07/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-08, 1393/07/16
Registrant information
Name
Ahmad Sarvarian
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 5075
Email address
dr.ahsarvarian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-07-20, 1390/04/29
Expected recruitment end date
2012-09-19, 1391/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tacrolymus on chronic allergic conjunctivitis
Public title
Effect of tacrolymus on allergic conjunctivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1. Allergic conjunctivitis.
Exclusion criteria:1.Blepharitis 2.Follicular blepharitis 3.Iritis 4.Eye infection 5.Evidence of herpes infection in the past
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the arak university of medical sciences
Street address
Arak University of Medical Sciences, Alamolhoda Ave
City
Arak
Postal code
Approval date
2011-06-22, 1390/04/01
Ethics committee reference number
90-109-13
Health conditions studied
1
Description of health condition studied
chronic allergic conjunctivitis
ICD-10 code
H10.4
ICD-10 code description
chronic conjunctivitis
Primary outcomes
1
Description
Eye pruritus
Timepoint
every week until one month then every month until 3 months
Method of measurement
VAS criteria
2
Description
Eye Erythema
Timepoint
every week until one month then every month until 3 months
Method of measurement
slit lamp exam
3
Description
Foreign body sensation
Timepoint
every week until one month then every month until 3 months
Method of measurement
VAS criteria
Secondary outcomes
1
Description
eye pain
Timepoint
every week until one month then every month until 3 months
Method of measurement
VAS criteria
2
Description
Ptosis
Timepoint
every week until one month then every month until 3 months
Method of measurement
VAS criteria
Intervention groups
1
Description
In control group patient will treat by Flucort Eye Drops every 6h and ketotifen eye drop every 12h and Dicloptin eye drop every 12h for 3 months.
Category
Treatment - Drugs
2
Description
In intervention group in addition to standard treatment in control group, patient will use topical tacrolimus with low thickness on the back of eyelids every night until a week then every 12h until 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Emam reza clinic
Full name of responsible person
Dr ahmad Sarvarian
Street address
City
arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice chancellor for research
Full name of responsible person
dr Ali Asghar Yaghoobi
Street address
Arak University Of Medical Sciences, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr ahmad sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 863135075
Fax
Email
dr.ahsarvarian@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr ahmad sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 863135075
Fax
Email
dr.ahsarvarian@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr ahmad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 863135075
Fax
Email
dr.ahsarvarian@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)