The main purpose of this randomized double-blind clinical trial study,is to evaluate the effect of Almond-Viola odorata oil on treatment of dry eye.90 Patients(18-60years old) with the complaint of dryness or foreign body in eye, eye burning, or photo phobia referred to Hazrat Rasoul Akram hospital, will be included in our study provided that have the following criteria: a- TUBT score, after 3 times of sequential measurement become less than 10 seconds: Schirmer test without topical anesthesia at least in one eye during 5 minutes become less than 10 millimeters: coloring cornea with flourocin at least in one eye. These patients will be assessed and the following scores will be recorded for each one: Score gained on OSDI questionnaire.The score of Schirmer test.Average time of TBUT. Then the patients will divided into 3 groups by the randomized block method. The patients in each group will receive nasal drop of Almond-Viola odorata oil or almond oil or placebo(two drop three times a day).After 4 weeks, the patients will be visited again and the tests in the first visit will be repeated. patients, researcher will be blind
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020626398N1
Registration date:2016-02-19, 1394/11/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-19, 1394/11/30
Registrant information
Name
Aniseh saffarshahroodi
Name of organization / entity
Shiraz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 7966
Email address
a-saffar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Almond-Viola odorata oil efficacy in dry eye disease, placebo-control, double blind randomized clinical trial
Public title
Almond-Viola odorata oil efficacy in dry eye disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: complaint of foreign body or dry eye and at least in one eye; TUBT score for 3 times after sequential measurements become less than 10 seconds or Schirmer test without topical anesthesia at least in one eye during 5 minutes become less than 10 millimeters or coloring cornea with flourocin at least in one eye; age 18-60 years old; ability to use nasal drop; complete the informed consent form; ability to come for follow up.
Exclusion criteria: the Schirmer test be less than 5 millimeters ; TUBT test be less than 5 seconds ;severe corneal coloring ;corneal ulcer at least in that eye ; filamentous keranopathy in that eye ;pregnancy or breast feeding ;any eye Surgery in the last 6 months ;any change in diet in the last month or during treatment ;the use of any topical eye drug during last 7 days in the affected eye ; patients who use topical eye drug due to another eye disease ;people who use contact lens ;use of corticosteroid in the last month ;use of anti-inflammatory drug for eye during last month ;use of corticosteroid or systemic anti-inflammatory drug Simultaneously with treatment ;use of any edible supplement
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.173
Health conditions studied
1
Description of health condition studied
Dry eye
ICD-10 code
H04.1
ICD-10 code description
Other disorders of lacrimal gland
Primary outcomes
1
Description
Foreign body sensation, photophobia, blur vision, Burning
Timepoint
Baseline,4weeks after starting the medication
Method of measurement
Filling OSDI questionnaire
2
Description
Tear Break Up time
Timepoint
Baseline,4weeks after starting the medication
Method of measurement
The time that takes for the first dry spot to appear following blinking after fluorescin instillation
3
Description
tear secretion
Timepoint
Baseline,4weeks after starting the medication
Method of measurement
measurement Schirmer test- Wetting of the filter paper after 5 minutes
4
Description
Tear osmolarity
Timepoint
Baseline,4 weeks after starting the medication
Method of measurement
Tear osmolarity maesurment via TearLab device-miliosmol /lit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention :Nasal drop(15ml) contain of Almond-Viola odorata oil, 3 times a day, every time 2 drop in each nostril for 4 weeks.
Category
Treatment - Drugs
2
Description
Control:Nasal drop(15ml) contain of placebo, 3 times a day, every time 2 drop in each nostril for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool General Hospital
Full name of responsible person
DR Aniseh saffarShahroodi
Street address
Niayesh St. Satarkhan Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Zand St.
City
Shiraz
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 of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Aniseh saffarShahroodi
Position
M.D./PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3230 5886
Fax
Email
Anisehsaffar@yahoo.com A-saffar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences, Eye Research Center
Full name of responsible person
Dr Hossein Aghaee
Position
Ophtalmologist-Anterior Segment and Cornea Fellowship
Other areas of specialty/work
Street address
Hazrat Rasool Akram General Hospital, Niayesh St. Satarkhan Ave.
City
Tehran
Postal code
Phone
+98 21 6435 2535
Fax
Email
Aghaee.h@iums.ac.ir - Aghaee.h1376@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Aniseh saffarShahroodi
Position
M.D./PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Zand Street
City
Shiraz
Postal code
Phone
Fax
Email
Anisehsaffar@yahoo.com, A-saffar@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)