<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20191230045954N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-02</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of tea tree oil on blepharitis-associated dry eye syndrome</public_title>
      <acronym>TTT (Tea Tree Trial)</acronym>
      <scientific_title>Tea tree oil effect on blepharitis-associated dry eye syndrome: a double-blind placebo control randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50043</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Dry eye disease. Condition 2: Blepharitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group received a gel containing 5% tea tree oil for massage on the eyelid twice a day for four weeks. Intervention 2: Control group: The control group receives tea tree oil-free gel every 12 hours (twice a day) which is massaged on the eyelid for four weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Hasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>hamidrezahasani@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Hasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahanshahr Blvd</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3143744692</zip>
        <telephone>+98 21 8865 0450</telephone>
        <email>hamidrezahasani@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age older than or equal to 18 years
Ocular Surface Disease Index(OSDI) test score greater than or equal to 22
Eyelid margin disease without severe inflammation
Strip Meniscometry (SM) Tubeّ test greater than or equal to 3-4 mm
People who sign the informed consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>99 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are very old and difficult to get information from
People who have received systemic treatment for eyelid disease at the time of admission or one month before admission
Receive any systemic treatment now or during the past month that affects tear secretion
People who wear contact lenses
Recent ocular surgery (less than 3 months ago)
Active disease in the anterior segment of the eyeball except dry eye (such as keratitis),
Patients with HIV (human immunodeficiency virus), sarcoidosis, graft versus host disease with previous diagnosis
Patients with rheumatic diseases, serious kidney disease (need for hemodialysis or history of kidney transplantation), diabetes, pregnancy, lactation, any dermatological or systemic disease that affects the surface of the eye
known medication allergies to the drugs used in this study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H04.1</hc_code>
      <hc_code>H01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of lacrimal gland</hc_keyword>
      <hc_keyword>Blepharitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group received a gel containing 5% tea tree oil for massage on the eyelid twice a day for four weeks.</i_keyword>
      <i_keyword>Control group: The control group receives tea tree oil-free gel every 12 hours (twice a day) which is massaged on the eyelid for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ocular Surface Disease Index (OSDI) questionnaire score. Timepoint: Measurement of OSDI questionnaire score at the beginning of the study (before the intervention) and 28 days after the start of the gel containing tea tree oil and placebo. Method of measurement: Fill out the questionnaire.</prim_outcome>
      <prim_outcome>Tear break up test. Timepoint: Measurement of tear break up test at the beginning of the study (before the intervention) and 28 days after the start of the gel containing tea tree oil and placebo. Method of measurement: Using fluorescein moistened with saline solution, the average time elapsed before the initial dissolution of the tear is measured three times.</prim_outcome>
      <prim_outcome>The amount of tear basal secretion. Timepoint: Measurement of tear basal secretion at the beginning of the study (before the intervention) and 28 days after the start of the gel containing tea tree oil and placebo. Method of measurement: Strip Meniscometry Tube.</prim_outcome>
      <prim_outcome>Corneal staining. Timepoint: Examination of corneal discoloration areas at the beginning of the study (before the intervention) and 28 days after the start of the gel containing tea tree oil and placebo. Method of measurement: By an ophthalmologist with a slit lamp and blue light to the cornea.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-30</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences,  Shahid Hemmat Highway,  Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
