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IRCT20220117053744N1 IRCT 2023-04-16 Shiraz University of Medical Sciences Studying the effect of a new type of honey eye drop on dry eye patients Studying the effect of a new type of honey eye drop on dry eye in patients with dry eye 2022-12-22 anticipated 80 Complete https://irct.ir/trial/63800 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We assigned patients a code from 1 to 80. Then we used a table of random numbers to select 40 numbers. For the 40 selected patients, the Honey eye drop was used for the treatment. In the other 40 patients, the (artificial tear) was used, Blinding description: First, informed consent was obtained from the patients .In order to blind, the desired drops are provided to patients in similar packages and in coded form, and patients will not be aware of the content of their medication. Patients will be aware that they will be randomly assigned to one of two treatment groups, but will be unaware of which treatment will be provided in that group. The physician also knows that patients will be anesthetized in two different ways, but will not know which procedure will be performed for each patient. The data collection officer, analyst and outcome assessor will collect and analyze information based on groups 1, 2 and will not be aware of the type of treatment provided in the groups. They will be kept blind. 3 dry eye syndrom. Intervention 1: Intervention group: treatment with honey drops (prepared from Gavan honey, produced by "Kandu Asal" company; 1% honey in Tearlose drops); Three times a day, one drop each time for one month, (routine treatment of dry eyes will not be removed for this group of patients). Intervention 2: Control group: Standard treatment includes artificial tears (Tearlose) three times a day, one drop each time for a month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mehdi Khaki
No. 196. Alley 41. North Motahhari Boulevard
Shiraz Iran (Islamic Republic of) 71849-15133 +98 901 043 0859 mehdikhaki1989@yahoo.com Shiraz University of Medical Sciences scientific Mehdi Khaki
No. 196.Alley 41 . North Motahhari Boulevard
Shiraz Iran (Islamic Republic of) 71849-15133 +98 901 043 0859 mehdikhaki1989@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients (male or female, without age limit) with dry eye syndrome (at three levels of low, moderate, and severe) Best corrected vision greater than or equal to 9/10 Schirmer test is less than 5 mm in 5 minutes Tear break time is less than 10 seconds no limit no limit Both Patients with blepharitis disorder Patients with meibomian gland disorder Patients with a history of taking tetracycline for the past three months Patients with a history of taking oral corticosteroids for the past three months Patients with ocular surface disorders Patients with a history of previous surgery Patients with a history of allergies H04.1 Other disorders of lacrimal gland Treatment - Drugs Treatment - Drugs Intervention group: treatment with honey drops (prepared from Gavan honey, produced by "Kandu Asal" company; 1% honey in Tearlose drops); Three times a day, one drop each time for one month, (routine treatment of dry eyes will not be removed for this group of patients) Control group: Standard treatment includes artificial tears (Tearlose) three times a day, one drop each time for a month Tear break up time (TBUT). Timepoint: 2, 4 and 6 weeks after starting treatment. Method of measurement: Clinical examination of the patient - per second. Corneal staining. Timepoint: 2, 4 and 6 weeks after starting treatment. Method of measurement: Clinical examination of the patient with Fluorescein test. Basic tear secretion rate. Timepoint: 2, 4 and 6 weeks after starting treatment. Method of measurement: Clinical examination of the patient - In millimeters per minute. Shiraz University of Medical Sciences Approved 2022-01-09 Ethics Committee in Research, Medical School -Shiraz University of Medical Sciences No. 16, Zand Blvd., Shiraz ُShiraz Fars Iran (Islamic Republic of)