Determining the effect of Vitamin E supplement on dry eye
Design
This study is a clinical trial with control group and parallel groups, double blind and randomized, each group consists of 45 patients were allocated in blocks of 6 patients in each one.
Settings and conduct
The population of the study includes patients aged 18-60 years with a dry eye disease. Ocular Surface Disease Index questionnaire is used to measure symptoms of patients with dry eye. Clinical tests implemented in the study include Tear Break Up Time and SMtube tests. Scores of these three tests are compared before and after the intervention.
Patients are unaware of the existence of two types of intervention ( Experiment group is receiving vitamin E supplement and artificial tear drop, and control group is receiving only artificial tear drops), also medical administrators (researcher and the ophthalmologist) and data analyzers are unaware of the type of intervention the patients are going to receive and the vitamin E supplement will be provided to them by a mediating agent.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients with Dry eye and questionnaire score above 10, TBUT test below 10 sec, and SM Tube test below 5 mm.
- Age range of 18-60 years
- Ability and consent of the patients to take part in the study
- Non pregnant female participants
Exclusion criteria:
- Allergic or reaction history of taking vitamin E
- History of blood coagulation disease
- History of taking vitamin E supplement over the past 3 months
Intervention groups
- Experiment group are receiving artificial tear drop three times a day (every 8 hours) and vitamin E supplement (400 IU) along with their meal for better absorption for 14 days.
- Control group are receiving only artificial tear drop three times a day (every 8 hours)
Main outcome variables
- Amount of tear secretion
- Tear break up time
- Dry eye symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044926N1
Registration date:2019-10-09, 1398/07/17
Registration timing:prospective
Last update:2019-10-09, 1398/07/17
Update count:0
Registration date
2019-10-09, 1398/07/17
Registrant information
Name
Parisa Moslemi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6684 7179
Email address
parisamoghadam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Oral Vitamin E on Dry Eye; A Randomized Clinical Trial
Public title
Effect of Vitamin E on Dry eye
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Dry eye syndrome and questionnaire score above 10
TBUT test below 10 sec.
SM Tube test below 5 mm.
Age range of 18-60 years
Ability and consent of the patients to take part in the study
Non pregnant female participants
No allergic or reaction history of taking vitamin E
No history of blood coagulation disease
No history of taking vitamin E supplement over the past 3 months
Exclusion criteria:
Patients with allergic or any kind of reactions with taking vitamin E
Patients with blood disorders/coagulation problems
Surgery history of Refractive errors
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is Block Randomization and 15 blocks of 6 in each are implemented. In this method the number of individuals in each group will be the same and blocks are formed based on 2 variables ( each block contains 6 variables which half of them is shown with an A letter that means receiving only artificial tear drop and the other half shown with B letter are going to receive vitamin E supplement and artificial tear drop).
According to the main purpose of this method which is balancing the individuals in each group, patients will be matched based on their age, sex and severity of dry eye and with the help of a statistics software are divided into experiment and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Despite the fact that there is no placebo in this study, patients are unaware of the existence of two types of intervention ( Experiment group is receiving vitamin E supplement and artificial tear drop, and control group is receiving only artificial tear drops), also medical administrators ( researcher and the ophthalmologist) and data analyzers are unaware of the type of intervention the patients are going to receive and the vitamin E supplement will be provided to them by a mediating agent.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Emam Hosein Square, Damavand Street
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.SBMU.REC.1398.044
Health conditions studied
1
Description of health condition studied
Dry eye
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of tear secretion
Timepoint
Evaluating the amount of tear secretion in the beginning of the study and two weeks after the intervention is done.
Method of measurement
Evaluating with Strip Meniscometry Test (SMTube)
2
Description
Tear Break Up Time
Timepoint
Evaluating the Tear Break Up Time in the beginning of the study and two weeks after the intervention is done.
Method of measurement
Evaluating with TBUT (Tear Break Up Time) test
3
Description
Symptoms of Dry eye
Timepoint
Evaluating the symptoms of Dry eye in the beginning of the study and two weeks after the intervention is done.
Method of measurement
Evaluating with Ocular Surface Disease Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One capsule of Vitamin E supplement (in dosage of 400IU per day) with lunch and artificial tear drop named Tear-i (produced in Alborz Daru Company) which contains 1/4 gram Polyvinyl alcohol per 100 milliliter every 8 hours one drop in each eye for 14 days
Category
Treatment - Drugs
2
Description
Control group: Artificial tear drop named Tear-i (produced in Alborz Daru Company) which contains 1/4 gram Polyvinyl alcohol per 100 milliliter every 8 hours one drop in each eye for 14 days