<?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>IRCT20220607055097N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-30</date_registration>
      <primary_sponsor>Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex</primary_sponsor>
      <public_title>Topical Azithromycin and oral doxycycline in meibomian gland dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of topical azithromycin with oral doxycycline in the treatment of meibomian gland dysfunction: A randomized clinical practice trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65203</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Prospective, randomized clinical practice trial, Randomization description: Simple randomization, unit of randomization taken as individual, non-stratified, Tools used in randomization was table of random numbers, allocation concealment was not carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Meibomian gland dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Topical Azithromycin 1%, Twice daily for 1 week followed by once daily for 3 weeks. Intervention 2: Intervention group: Oral Doxycycline 100 mg, once daily for 4 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Adnan Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Civil colony</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 2586506</telephone>
        <email>dradnanahmad@hotmail.com</email>
        <affiliation>Nowshera Medical College, Nowshera</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Adnan Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Civil colony</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 2586506</telephone>
        <email>dradnanahmad@hotmail.com</email>
        <affiliation>Nowshera Medical College, Nowshera</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All the patients within the specified age group with posterior blepharitis secondary to meibomian gland dysfunction
Patients with meibomian gland dysfunction, non responsive to conventional therapy such as lid massage, warm compresses and lid scrubbing</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>42 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with blepharitis other than posterior one
Patients with other inflammatory lid conditions like atopic blepharoconjunctivitis
Patients with traumatic eyelid injuries
Patients with neoplastic lid disorders
Pregnant, conceiving and lactating females
history of any allergy to the study drugs
Patients treated with oral or topical medications other than study drugs for posterior blepharitis within 3 months period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H01.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Blepharitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Topical Azithromycin 1%, Twice daily for 1 week followed by once daily for 3 weeks</i_keyword>
      <i_keyword>Intervention group: Oral Doxycycline 100 mg, once daily for 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean improvement in symptoms score. Timepoint: Baseline, 2nd and 4th week. Method of measurement: Subjective symptoms including itchy eyes, grittiness, MG plugging, foreign body (FB) sensation and watering were recorded in a check list as 0 = asymptomatic, 1= moderate and 2 = severe symptoms.</prim_outcome>
      <prim_outcome>Mean improvement in corneal staining. Timepoint: Baseline, 2nd and 4th week. Method of measurement: For corneal staining, we divided the cornea into five regions and assigned a score of 1 for peripheral staining and 4 for staining of central cornea implying more severe involvement by the disease process.</prim_outcome>
      <prim_outcome>Mean improvement in bulbar conjunctival hyperaemia. Timepoint: Baseline, 2nd and 4th week. Method of measurement: For bulbar conjunctival hyperaemia, area was divided into six regions and scoring from 0 to 4 was done depending upon the number of involved regions.</prim_outcome>
      <prim_outcome>Mean improvement in Schirmer 1 test. Timepoint: Baseline, 2nd and 4th week. Method of measurement: Schemers 1 test (5 min. test without anesthesia) were performed in all of the participants, &gt; 10 mm wetting was considered as normal.</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>Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-20</approval_date>
        <contact_name>Institutional Ethical Review Board of Nowshera Medical College</contact_name>
        <contact_address>Mardan road, near Kabul river, Nowshera Nowshera Khyber Pukhtoonkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
