To evaluate efficacy of green tea extract as EyeCalmin eye drop (Dinee company) on signs and symptoms of ocular surface irritation such as redness, pruritus, foreign body sensation and eyestrain. In this clinical trial 30 patients with ocular surface irritation were enrolled. They randomly received Eyecalmin eyedrop or placebo. Patients examined before the enrollment, then they take drugs four times a day for two weeks and the second examination was performed. After passing the time required for drug washout, the same patients received the alternate drug and examination with the same schedule was performed. The results of the two drugs compared in the same patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903234166N1
Registration date:2010-09-15, 1389/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-15, 1389/06/24
Registrant information
Name
Rana Daei Sorkhabi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
rana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-09-07, 1388/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of EyeCalmin eye drop on inflammation of ocular surface
Public title
Efficacy of green tea extract on ocular redness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.ocular redness 2.foriegn body sensation 3.eyestrain 4.ocular allergy. Exclusion criteria: 1.any intraocular inflammation 2.any corneal disease 3.viral or bacterial infections 4.any drug induced side effects
Age
From 30 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Drug Applied Research Center
Street address
Daneshgah avenue
City
Tabriz
Postal code
Approval date
2009-02-10, 1387/11/22
Ethics committee reference number
2922/4/5
Health conditions studied
1
Description of health condition studied
ocular surface irritation
ICD-10 code
H10.1
ICD-10 code description
Acute atopic conjunctivitis
Primary outcomes
1
Description
forignn body sensation, redness, irritation, eye strain
Timepoint
2 weeks
Method of measurement
clinical exam
Secondary outcomes
1
Description
tear film stability
Timepoint
2 weeks
Method of measurement
clinical exam
Intervention groups
1
Description
eyecalmin 4 times a day for two weeks
Category
Treatment - Drugs
2
Description
placebo 4 times a day for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university clinics
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Reaserch Center
Full name of responsible person
Hossein Babaei
Street address
Educational Development Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Reaserch Center
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
Tabriz universit of medacal sciences
Full name of responsible person
Rana Daei Sorkhabi
Position
Assistant professor
Other areas of specialty/work
Street address
Tabriz Nikookari hospital
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
sorkhabi_r@yahoo.com , rana@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Rana Daei Sorkhabi
Position
fellowship of cornea
Other areas of specialty/work
Street address
Tabriz Nikookari hospital
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
rana@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)