<?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>IRCT20181006041253N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-08</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Nano-Tacrolimus and Cyclosporine effect in dry eye</public_title>
      <acronym></acronym>
      <scientific_title>Comparative clinical evaluation of 0.05% Cyclosporine and 0.05% Nano -Tacrolimus eye drops for the treatment of dry eye</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34353</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We assigned patients a code from 1 to 12. Then we used a table of random numbers to select 12 numbers. For the 12 selected patients, the 0.05%   Nano- Tacrolimus drug was used in the right eye and the 0.05% CsA drug was used in the left eye. On the other 12 patients, 0.05%   Nano- Tacrolimus was used in the left eye  and the 0.05% CsA drug was used in the right eye, Blinding description: In this study,the ophthalmologist who performs the examination and evaluation of the patients and the person who performs the data analysis is unaware of which drug is used.</study_design>
      <phase>3</phase>
      <hc_freetext>Dry eye syndrome.</hc_freetext>
      <i_freetext>Intervention 1: International group 1: 0.05% nano formulation Tacrolimus  drop produced at the Abu Reyhan Pharmacy Company for one eye twice a day, One drop use in the lower conjunctiva for one month. Intervention 2: International group 2: Cyclosporine drop Sinadarou Company uses a drop in the lower conjunctiva for one month twice a day for another eye.</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 Because of the publication of the article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mozhgan Ahrary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Street</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717964151</zip>
        <telephone>+98 56 3244 5402</telephone>
        <email>mozhganahrarii@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Nikandish</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Street</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717964151</zip>
        <telephone>+98 56 3244 5402</telephone>
        <email>malihenikandish@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>chronic symptoms of burning, foreign body sensation or itching in both eyes, blurring of vision, photo phobia,and pain
daily need for artificial tears
The ocular surface disease index (OSDI)≥23
tear film break-up time (TBUT) value of 10s or lower
Strip Meniscometry test (SM tube) ≤ 10 mm
Schirmer  test value at 5 min of 10mm or lower</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>78 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to tacrolimus
Pregnancy or lactation
Other systemic atopic diseases
Previous eye surgery
Any structural abnormalities (lid scarring, entropion, trichiasis, etc.)
Any inflammation in the anterior chamber
Glaucoma
Use of other topical drugs, other than artificial tears
Use of topical or systemic antibiotics or anti-inflammatory drugs  before entering the study
Contact lens
punctual occlusion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H04.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of lacrimal gland</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>International group 1: 0.05% nano formulation Tacrolimus  drop produced at the Abu Reyhan Pharmacy Company for one eye twice a day, One drop use in the lower conjunctiva for one month.</i_keyword>
      <i_keyword>International group 2: Cyclosporine drop Sinadarou Company uses a drop in the lower conjunctiva for one month twice a day for another eye.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Foreign body sensation. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).</prim_outcome>
      <prim_outcome>Tear film break up time test (TBUT). Timepoint: Before intervention and one month after treatment. Method of measurement: In seconds, with a timer and slit lamp.</prim_outcome>
      <prim_outcome>Production of tears. Timepoint: Before intervention and one month after treatment. Method of measurement: Schirmer's test in millimeters.</prim_outcome>
      <prim_outcome>Tear volume measurement (SM Tube). Timepoint: Before intervention and one month after treatment. Method of measurement: The SM Tube strip is held in the lower lip for 5 seconds. After 5 seconds, the height of the absorbed tear of the blue column is measured.</prim_outcome>
      <prim_outcome>Light sensitivity. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).</prim_outcome>
      <prim_outcome>Blurred vision. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).</prim_outcome>
      <prim_outcome>Eye irritation. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-20</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
