<?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>IRCT20181229042160N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-24</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of antibacterial peptide eye drops</public_title>
      <acronym>EAPED</acronym>
      <scientific_title>Safety evaluation of eye drops containing antibacterial peptides in the treatment of infectious bacterial keratitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74490</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Bacterial keratitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Treatment using standard antibiotic eye drops (ceftazidime + vancomycin). Intervention 2: Treatment is done using standard antibiotic eye drops (ceftazidime + vancomycin) along with drops containing CM11 antibacterial peptide. For this purpose, eye drops containing 16 µg/ml peptide will be used. During the first week of treatment, patients use peptide drops at 4-hour intervals, and after that, at 6-hour intervals until the infection treatment. The peptide consists of 11 amino acids, synthesized by Morvarid Darou Company in pharmaceutical grade and formulated by Sina Darou Company. This peptide has broad-spectrum antibacterial activity.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be presented after the study is done, keeping the identity of the people.

When:
Access starts 3 months after results are published.

To whom:
It is accessible to everyone.

Conditions:
There is no limit.

Where to obtain:
Using the email listed in the published article.

How to obtain:
By email and stating the reason for the request, which will be answered within a maximum of one week process.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrdad Moosazadeh Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tissue Engineering Research Center, Baqiyatallah University of Medical Sciences, Nosrati Alley., South Sheikh Bahai St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 4808</telephone>
        <email>mm.genetics@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khosrow Jadid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Ophthalmology, Baqiyatallah Hospital, Mullasadra St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 4808</telephone>
        <email>kh.jadidi@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with bacterial keratitis caused by Staphylococcus aureus or Pseudomonas aeruginosa
Having consent to enter the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient's lack of consent to continue the examinations
Occurrence of any unusual side effects
Infectious keratitis of fungal origin
Spread of infection to other parts of the eye
Having systemic immunodeficiency
Having a cornea transplant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Keratitis</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>Control group: Treatment using standard antibiotic eye drops (ceftazidime + vancomycin)</i_keyword>
      <i_keyword>Treatment is done using standard antibiotic eye drops (ceftazidime + vancomycin) along with drops containing CM11 antibacterial peptide. For this purpose, eye drops containing 16 µg/ml peptide will be used. During the first week of treatment, patients use peptide drops at 4-hour intervals, and after that, at 6-hour intervals until the infection treatment. The peptide consists of 11 amino acids, synthesized by Morvarid Darou Company in pharmaceutical grade and formulated by Sina Darou Company. This peptide has broad-spectrum antibacterial activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Keratitis infection. Timepoint: 3, 7, and 14 days after drug administration. Method of measurement: Microscopic evaluation using Slit lamp.</prim_outcome>
      <prim_outcome>Treatment duration. Timepoint: 3, 7, and 14 days after drug administration. Method of measurement: Microscopic evaluation using Slit lamp.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Corneal opacity. Timepoint: 7, 14, 30 and 90 days. Method of measurement: Microscopic evaluation using Slit lamp.</sec_outcome>
      <sec_outcome>Pain and burning. Timepoint: 7, 14, 30 and 90 days. Method of measurement: Microscopic evaluation using Slit lamp.</sec_outcome>
      <sec_outcome>Shedding tears. Timepoint: Macroscopic and microscopic evaluation using Slit lamp. Method of measurement: 7, 14, 30 and 90 days.</sec_outcome>
      <sec_outcome>Eye redness. Timepoint: 7, 14, 30 and 90 days. Method of measurement: Macroscopic and microscopic evaluation using Slit lamp.</sec_outcome>
      <sec_outcome>Eye inflammation. Timepoint: 7, 14, 30 and 90 days. Method of measurement: Microscopic evaluation using slit lamp.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-16</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Tissue Engineering Research Center, Baqiyatallah University of Medical Sciences, Nusrati Alley., South Sheikh Bahai St., Mullasadra St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
