Tea tree oil effect on blepharitis-associated dry eye syndrome: a double-blind placebo control randomized clinical trial

The effect of tea tree oil on blepharitis-related dry eye syndrome is investigated.

A clinical trial with control group, with parallel groups, double-blind, randomized, on 100 patients. Block randomization was used for randomization.

In this study, patients referred to the ophthalmology clinic of Firoozabadi, Rasoul Akram and Lolagar hospitals whom have the necessary conditions were included in the study and after performing the necessary tests and examinations, they were randomly received drugs or placebo in the control group or intervention. After 4 weeks, they are re-examined. The study is performed in a double-blind manner; throughout the study, researchers are unaware of the belonging of each drug and placebo to the groups, and patients will not be aware of the name of the drug received and its effects. Medication and placebo are prescribed by a doctor outside the research team.

Inclusion criteria: patients with blepharitis or dry eye older than or equal to 18 years; ocular surface disease index score above 22 ,strip meniscometry tube test score equal or above 3 mm. Exclusion criteria include use of topical ocular treatments; receiving any systemic treatment now or during the past month that affects the tear secretion, contact lens use, recent ocular surgery; anterior segment active inflammation; pregnancy; lactation; any dermatological or systemic disease that affects the surface of the eye.

The control group receives tea tree oil-free gel every 12 hours which is massaged on the eyelid for four weeks and the intervention group receives tea tree oil gel 5% for massage on the eyelid twice a day for four weeks.

Severity of blepharitis symptoms and signs; tear break-up time, basal surface secretion of tear; corneal stippling; severity of dry eye symptoms and signs

In this study, random allocation to be placed in the tea tree oil group or placebo to receive intervention at the standard time will be done using the permuted balance block randomization technique. According to this issue, the blocks considered in this study will be quadruple blocks. Using STATA software, a random number chain of 1 to 6 will be generated to reach the desired sample size. Considering that the total number of cases for receiving medicine in 4 blocks is 6, if the number produced is more than 6, the next number will be produced without considering it. Preparation of random assignment sequences of drug groups and placing them in sealed envelopes and numbering with a 5-digit serial number will be done by a third party who is not involved in the design of the study. All envelopes have a number The series will be 5 digits, which will be opened immediately after the patients enter the study, and the patients will be divided into two groups.

The study is performed in a double-blind manner. Throughout the study, researchers were unaware that each medication and placebo belonged to the group and patients will not be aware of the name of the Medication and its effects. Medication and placebo are prescribed by a doctor outside the research team.