The purpose of this study is the evaluation of efficacy of topical Cyclosporin 2% in the treatment of acute anterior non-infectious uveitis. The question is whether the addition of topical Cyclosporin 2%, as an immunosuppressive agent, to topical steroid, which is the mainstay of treatment in acute anterior uveitis, can lead to diminution of topical steroid dosage?
The study design is double blind randomized placebo-controlled single center trial. The patients older than 18 years diagnosed as having acute anterior non-infectious uveitis, will be included. Sixty trial patients are randomly assigned into equal groups of 30, group A and B, receiving drop A or drop B, one drop four times daily in addition to topical prednisolon. Drop A and B contain either cyclosporin2% or placebo (artificial tear). The participants and researcher are blind to the type of treatment.
The primary outcome is the mean time to remission of intraocular inflammation in each group. The secondary outcome is the side effect(s) of topical cyclosporin2%.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112731135N1
Registration date:2017-02-12, 1395/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Mohammad Arjmand
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3705 0223
Email address
arjmandm921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Researh, Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-21, 1395/11/02
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical effect of topical Prednisolon with and without topical Cyclosporin 2% in the treatment of acute non infectious anterior uveitis
Public title
The effect of topical Cyclosporin in uveitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: First episode of acute anterior non-infectious uveitis with +3 or +4 cell in anterior chamber; Completion of informed consent; Older than 18 years; No history of topical drug consumption; No history of previous ocular surgery; Not pregnant or decision for pregnancy.
Exclusion criteria: Exclusion request for any reason at any time; Lack of timely patient; Not compliant patient; The incidence of drug sensitivity
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Mashhad University of Medical Sciences
Street address
Research Chancellor of Mashhad University of Medical Sciences, Ghoreyshi building, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.MUMS.fm.REC.1394.329
Health conditions studied
1
Description of health condition studied
Acute Anterior Uveitis
ICD-10 code
H20.0
ICD-10 code description
Acute and subacute iridocyclitis Anterior uveitis Cyclitis Iritis acute, recurrent or subacute
Primary outcomes
1
Description
Mean time to remission of intraocular inflammation
Timepoint
Each 72 hours until complete remission of intraocular inflammation
Method of measurement
with Slit Lamp and according to SUN Group criterion
Secondary outcomes
1
Description
Incidence of ocular complications such as burning, Dryness and tearing
Timepoint
Each 72hours
Method of measurement
Ask from patient
2
Description
Intraocular pressure
Timepoint
Each 72hours
Method of measurement
with Goldman tonometer in mmHg
Intervention groups
1
Description
Patients in the intervention group receiving topical Cyclosporin2% four times daily(in addition to the standard treatment of uveitis) until complete remission of inflammation.
Category
Treatment - Drugs
2
Description
Patients in control group receiving artificial tear four times daily( in addition to standard treatment of uveitis) until complete remission of inflammation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia Hospital
Full name of responsible person
Dr. Mohammad Arjmand
Street address
Khatam-Al-Anbia Hospital, Gharani Blvd, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Chancellor of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Building, Daneshgah Ave, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Chancellor of Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjmand
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Azadi Sq, Mashhad
City
Mashhad
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3728 5290
Email
Arjmandm921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyde Maryam Hoseini
Position
Ophthalmologist. Uveitis Fellowship
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Azadi Sq, Mashhad
City
Mashhad
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3728 5290
Email
Hoseinimm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjmand
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Azadi Sq, Mashhad
City
Mashhad
Postal code
9195965919
Phone
+98 51 3728 1400
Fax
+98 51 3728 5290
Email
Arjmandm921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)