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IRCT20190929044926N1 IRCT 2019-10-09 Shahid Beheshti University of Medical Sciences Effect of Vitamin E on Dry eye Evaluation of the Effect of Oral Vitamin E on Dry Eye; A Randomized Clinical Trial 2019-10-12 anticipated 90 Complete https://irct.ir/trial/42652 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Dry eye. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data from questionnaires and results of the tests When: Accessibility period will be 3 months after publishing the results To whom: Researchers working at scientific institutions Conditions: Refering to the reference of data Where to obtain: Parisa Moslemi Moghadam Email: parisamoghadam95@yahoo.com Phone number: 00989189730753 How to obtain: Sending the request of receiving data and waiting for the result till at least 1 month later Comments:
public Parisa Moslemi Moghadam
Emam Hosein Square, Damavand Street
Tehran Iran (Islamic Republic of) 1616913111 +98 21 6684 7179 Parisamoghadam95@yahoo.com Shahid Beheshti University of Medical Sciences scientific Parisa Moslemi Moghadam
Emam Hosein Sq, Damvand Street
Tehran Iran (Islamic Republic of) 1616913111 +98 21 6684 7179 Parisamoghadam95@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both Patients with allergic or any kind of reactions with taking vitamin E Patients with blood disorders/coagulation problems Surgery history of Refractive errors Treatment - Drugs Treatment - Drugs 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 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 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). 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. 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. Shahid Beheshti University of Medical Sciences Approved 2019-07-21 Ethics committee of Shahid Beheshti University of Medical Sciences Emam Hosein Square, Damavand Street Tehran Tehran Iran (Islamic Republic of)