Randomized controlled trial for evaluation of safety and efficacy of topical cyclosporine 2% versus topical prednisolone for treatment of herpetic interstitial keratitis
Objectives: To evaluate the efficacy of topical cyclosporine 2% for treatment of herpetic interstitial keratitis.
Design: Prospective randomized controlled clinical trial, single center, single blinded to patients. Two arms of study will be 24 eyes of 24 patients in cyclosporine group and 24 eyes of 24 patients in conventional treatment group.
Setting and conduct: Feiz hospital, Isfahan University of Medical Sciences. Patients who are allotted for treatment of herpetic interstitial keratitis will randomly assigned to conventional corticosteroid or cyclosporine groups while receiving standard prophylactic oral Acyclovir treatment. Subjects will be evaluated 2 and 4 weeks after initiation of treatment regarding corneal haziness and visual acuity.
Participants: Patients with herpetic interstitial keratitis who are candidate to begin topical immunosuppressive therapy for treatment of the condition. Patients with history of treatment of the current condition with corticosteroids will not enter into the study.
Intervention: Topical application of cyclosporine
Main outcome measures: cornea haziness, visual acuity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052112724N2
Registration date:2015-10-28, 1394/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-28, 1394/08/06
Registrant information
Name
Alireza Peyman
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3445 2031
Email address
peyman@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial for evaluation of safety and efficacy of topical cyclosporine 2% versus topical prednisolone for treatment of herpetic interstitial keratitis
Public title
Topical cyclosporine 2% for herpetic interstitial keratitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of herpetic interstitial keratitis, No history of treatment with any form of immunosuppressant drugs one month before intervention, No history of diabetes mellitus, No history of co-existing viral disease.
Exclusion criteria: Any side effect attributable to study, patients who have not used drugs regularly, patients who have not come for follow up visits.
Age
From 16 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be randomly assigned to intervention and control groups with a random allocation software program. The patients will not be aware of the content of coded drop bottles but the examiners will know about the type of delivered drops.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib St.,
City
Isfahan
Postal code
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
ir.mui.rec.1394.3.321
Health conditions studied
1
Description of health condition studied
Herpetic interstitial keratitis
ICD-10 code
H19.1
ICD-10 code description
Herpesviral keratitis and keratoconjunctivitis
Primary outcomes
1
Description
Cornea haziness
Timepoint
Before and 1 month after treatment
Method of measurement
Pentacam optical densitometry
Secondary outcomes
1
Description
Visual acuity
Timepoint
Before and 1 month after treatment
Method of measurement
Snellen chart
Intervention groups
1
Description
Group 1: Intervention group, treatment with topical Cyclosporine 2 % (provided by Sinadarou company) 1 gtt every 12 hours
Category
Treatment - Drugs
2
Description
Group 2: Control group, treatment with topical prednisolone acetate 1% (Precord, Sinadarou company), 1 gtt every 6 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Dr Nayebzade
Street address
Modares St.,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Hezarjerib St., Isfahan University of Medical Sciences, Headquarters No.4 building, Vice-chancellery for Research and Technology
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohsen Pourazizi
Position
Resident
Other areas of specialty/work
Street address
Feiz hospital, Modares St.,
City
Isfahan
Postal code
81938
Phone
+98 31 3445 2031
Fax
Email
mr.nayebzade@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Alireza Peyman
Position
Assistant professor
Other areas of specialty/work
Street address
Feiz hospital, Modares St.,
City
Isfahan
Postal code
81938
Phone
+98 31 3445 2031
Fax
Email
peyman@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Alireza Peyman
Position
Assistant professor
Other areas of specialty/work
Street address
Feiz hospital, Modares St.,
City
Isfahan
Postal code
81938
Phone
+98 31 3445 2031
Fax
Email
peyman@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)