Comparison of artificial tear drops and baby shampoos as treatments of dry eye syndrome(DES), with and without the administration of simple eye ointment
In this clinical trial study which is carried out to compare artificial tear drops and baby shampoos as treatments of dry eye syndrome, with and without the administration of simple eye ointment, patients with DES receipted at the ophthalmology clinic of Semnan Kowsar Hospital or at the concerning ophthalmologist's office, are evaluated by the inclusion criteria, before entering the study.
The main inclusion criteria: Patients must be between 20 and 60 years old. Patients must be diagnosed with DES for first time. Patients with idiopathic DES, not secondary types.Disease progression must be staged as mild or moderate.No history of undergoing refractive errors surgeries, utilizing contact eye lens and any drugs associated to DES
The main exclusion criteria:- Refusal to keep participating in the study.Intolerance to treatment
Patients enter the study by categorization in two thirty member groups throw packet randomization. In control group, patients will be treated by baby shampoo and artificial tear drop, while in intervention group, simple eye ointment will be also applied in addition. Patients will be visited at 0, 2 and 4 weeks and collected data will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090923952N1
Registration date:2015-10-08, 1394/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-08, 1394/07/16
Registrant information
Name
Goldis Espandar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3335 4359
Email address
goldisespandar@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery of Research of Semnan University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of artificial tear drops and baby shampoos as treatments of dry eye syndrome(DES), with and without the administration of simple eye ointment
Public title
Effect of simple eye ointment on treatment of dry eye syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with DES clinical signs and symptoms which are confirmed by TBUT test; Patients must be between 20 and 60 years old; Patients must be diagnosed with DES for first time; Patients with idiopathic DES, not secondary types; Patients' workplace must be indoor; Patients must not take any ophthalmic drugs so far; Disease progression must be staged as mild or moderate; No history of undergoing refractive errors surgeries, utilizing contact eye lens and any drugs associated to DES; Informed consent for being involved in the study
Exclusion criteria: Refusal to keep participating in the study; Intolerance to treatment
Age
From 20 years old to 60 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basij boulevard, Semnan
City
Semnan
Postal code
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.SEMUMS.REC.1394.73
Health conditions studied
1
Description of health condition studied
dry eye syndrome
ICD-10 code
H04.1
ICD-10 code description
Lacrimal: cyst gland atrophy
Primary outcomes
1
Description
Patients remission rate
Timepoint
before Intervention, 2 weeks after intervention and 4 weeks after intervention
Method of measurement
International Dry Eye Workshop(DEWS)
Secondary outcomes
1
Description
Side effects of simple eye ointment
Timepoint
1 month after intervention
Method of measurement
Standard questionnaire
Intervention groups
1
Description
Control group:
1- Baby shampoo, every night, local, for 4 weeks
2- Artificial tear drop; in mild stages every 8 hours 1 drop in both eyes, and in moderate stages every 6 hours 1 drop in both eyes, for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention group:
1- Baby shampoo, every night, local, for 4 weeks
2- Artificial tear drop; in mild stages every 8 hours 1 drop in both eyes, and in moderate stages every 6 hours 1 drop in both eyes, for 4 weeks
3- Simple eye ointment, every night, 0.5-1.0 cm2 in lower eyelid, in both eyes, for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Kowsar Hospital
Full name of responsible person
Dr.Goldis Spandar, ophthalmologist
Street address
Kowsar Hospital, Golestan town, Semnan
City
Semnan
2
Recruitment center
Name of recruitment center
Ophthalmologist's Office
Full name of responsible person
Dr.Goldis Spandar, Ophthalmologist
Street address
Third floor, Sadaf complex, Saadi square, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery of Research of Semnan University of Medical Sciences
Full name of responsible person
Dr.Rashidipour
Street address
Basij boulevard, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery of Research of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hamid Mirhoseiny
Position
Medical Student
Other areas of specialty/work
Street address
Third floor, 1 block, Shaghayegh square, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 5404
Fax
Email
mirhoseiny.hamid@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Goldis Espandar
Position
Ophtalmologist
Other areas of specialty/work
Street address
Basij boulevard, Semnan
City
Semnan
Postal code
Phone
+98 23 3344 8996
Fax
Email
info@semums.ac.ir
Web page address
www.semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Pourazizi
Position
Medical Student
Other areas of specialty/work
Street address
Basij boulevard, Semnan
City
Semnan
Postal code
Phone
00
Fax
Email
m.pourazizi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)