Dry eye is a common medical condition in Tehran due to air pollution and dry climate. Other than the lid hygiene and artificial tears drop which replaces the evaporated tears there is definite treatment for this condition. Previous clinical experience has shown that Omega-3 supplements can improve dry eye condition. This clinical trial is designed to observe the impact of Omega-3 Supplements on clinical signs and symptoms of dry eye. The subjects are divided into two groups of treatment and control. The treatment group would receive 1 gram of Omega-3 Capsule b.i.d. The control group would receive 1 gram of Placebo Capsule b.i.d. for 1 month. Before and After treatment, the OSDI questionnaire would be completed, Tear Break Up time and Schirmer test Without anesthetic would be performed.
The Omega-3 Supplements and placebo capsules are manufactured by Zahravi Pharmaceutical Company, Iran.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012265467N1
Registration date:2012-04-03, 1391/01/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-03, 1391/01/15
Registrant information
Name
Haleh Kangari
Name of organization / entity
College of Rehabilitation, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1723
Email address
hkangari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Omega-3 Fatty Acids Supplements on Dry Eye
Public title
The Impact of Omega-3 on Dry Eye
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects with Tear Break up time of less than 10 seconds
Exclusion Criteria: The subjects with blood coagulation problems and those who take blood thinning medications such as warfarin or Coumadin, subject with the history of stomach ulcer, hemorrhage, or surgery in the past three months, history of allergies to fish oil or gelatinous capsules.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
ُShahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yeman Ave., Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2011-09-11, 1390/06/20
Ethics committee reference number
6066-7245-93-01-89
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
Tear Break Up time
Timepoint
Before and after one month intervention
Method of measurement
The time that takes for the first dry spot to appear following blinking after fluorescin instillation
2
Description
Tear secretion
Timepoint
Before and after intervention
Method of measurement
Schirmer test- Wetting of the filter paper after 5 minutes
3
Description
Foreign body sensation, photophobia, blur vision, Burning
Timepoint
Before and after intervention
Method of measurement
Filling OSDI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Omega-3 Capsule b.i.d. for one month
Category
Treatment - Drugs
2
Description
Placebo gelatinous capsule b.i.d for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation
Full name of responsible person
Dr. Haleh Kangari
Street address
College of Rehabilitation, Next to Bakhshifard Street, Damavand Ave., Emam Hossein Square, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Dr. Mohammad Hossein Eftekhari 's Private Practice
Full name of responsible person
Azam Sardari
Street address
أNo. 1955 Shariati Ave. ,Close to Ghods Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mehri Ghassemi, College of Rehabilitation, Shahid Beheshti University of Medical Sciences
Street address
Shahid Behesti University of Mecical Sciences, Next to Talegahani Hospital,Yeman Ave., Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation, Optometry Department
Full name of responsible person
Dr. Haleh Kangari
Position
Doctor of Optometry, Head of Optometry Department
Other areas of specialty/work
Street address
College of Rehabilitation, Corner of Bakhshifard Street, Damavand Ave., Emam Hossein Square
City
Tehran
Postal code
1616013111
Phone
+98 21 7756 1723
Fax
+98 21 7756 1406
Email
halehkangari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation
Full name of responsible person
Dr. Haleh Kangari
Position
Dr. of Optometry, Head of Optometry Department
Other areas of specialty/work
Street address
College of Rehabilitation, Corner of Bakhshifard Street, Damavand Ave. , Emam Hossein Square
City
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Fax
+98 21 7756 1409
Email
halehkangari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
College of Rehabilitation, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Sardari
Position
MS student
Other areas of specialty/work
Street address
College of Rehabilitation, Corner of Bakhshifard Street, Damavand Avenue, Emam Hossein Square, Tehran
City
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Fax
+98 21 7756 1406
Email
sardari_op@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)