xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974124</url>
    </required_header>
    <id_info>
      <org_study_id>OS1</org_study_id>
      <nct_id>NCT05974124</nct_id>
    </id_info>
    <brief_title>Effectiveness of Ophthalmic Antiseptic Preparations</brief_title>
    <official_title>Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>European School of Advanced Studies in Ophthalmology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics,&#xD;
        povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35&#xD;
        patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX&#xD;
        0.02% with the same posology. The contralateral eye was considered as control. Conjunctival&#xD;
        swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1)&#xD;
        all before cataract surgery. Conjunctival bacterial load has been evaluated through a&#xD;
        molecular based method at T0 and T1 and compared to the control eye.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 9, 2022</start_date>
    <completion_date type="Actual">February 3, 2023</completion_date>
    <primary_completion_date type="Actual">February 3, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants were randomised to instill either povidone-iodine eye drops (35 patients) or chlorhexidine (35 patients) in the eye to be operated on. The contralateral eye was considered as control and received no antiseptic prophylaxis.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Conjunctival composition</measure>
      <time_frame>3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.</time_frame>
      <description>Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient pain score</measure>
      <time_frame>Day 3: after 3 days of treatment</time_frame>
      <description>Numerical rating scale, from 0 to 10</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance of the patients</measure>
      <time_frame>Day 3: after 3 days of treatment</time_frame>
      <description>Questionnaire about patients' compliance</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>Antiseptics</condition>
    <condition>Microbiota</condition>
    <condition>Conjunctiva</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Povidone-Iodine 0.66%</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Chlorhexidine 0.02%</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Povidone-Iodine 0.66%</intervention_name>
      <description>Povidone-iodine 0.66% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Chlorhexidine 0.02%</intervention_name>
      <description>Chlorhexidine 0.02% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing cataract surgery&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Reported allergy or hypersensitivity to iodine or chlorhexidine&#xD;
  &#xD;
            -  Active ocular infection&#xD;
  &#xD;
            -  Contraindication to surgery&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Patients residing in nursing homes or prison&#xD;
  &#xD;
            -  Patients who used antibiotic, antiviral or antifungal eye drops in the week preceding&#xD;
               the intervention&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vito Romano, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Università degli Studi di Brescia</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</name>
        <address>
          <city>Brescia</city>
          <zip>25123</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</investigator_affiliation>
      <investigator_full_name>Vito Romano</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Povidone-iodine</keyword>
    <keyword>Chlorhexidine</keyword>
    <keyword>Preoperative</keyword>
    <keyword>Antiseptics</keyword>
    <keyword>Conjunctival bacterial flora</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chlorhexidine</mesh_term>
      <mesh_term>Povidone-Iodine</mesh_term>
      <mesh_term>Povidone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>After completion of the study</ipd_time_frame>
      <ipd_access_criteria>Upon approval of individual sharing request</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974124
  org study id: OS1
  nct id: NCT05974124
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics,
        povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.
  70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35
        patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX
        0.02% with the same posology. The contralateral eye was considered as control. Conjunctival
        swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1)
        all before cataract surgery. Conjunctival bacterial load has been evaluated through a
        molecular based method at T0 and T1 and compared to the control eye.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants were randomised to instill either povidone-iodine eye drops (35 patients) or chlorhexidine (35 patients) in the eye to be operated on. The contralateral eye was considered as control and received no antiseptic prophylaxis.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Conjunctival composition
  time frame: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.
  description: Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota
  measure: Patient pain score
  time frame: Day 3: after 3 days of treatment
  description: Numerical rating scale, from 0 to 10
  measure: Compliance of the patients
  time frame: Day 3: after 3 days of treatment
  description: Questionnaire about patients' compliance
  arm group label: Group A
  arm group type: Experimental
  description: Povidone-Iodine 0.66%
  arm group label: Group B
  arm group type: Experimental
  description: Chlorhexidine 0.02%
  intervention type: Device
  intervention name: Povidone-Iodine 0.66%
  description: Povidone-iodine 0.66% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.
  arm group label: Group A
  intervention type: Device
  intervention name: Chlorhexidine 0.02%
  description: Chlorhexidine 0.02% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vito Romano, MD
  role: Principal Investigator
  affiliation: Università degli Studi di Brescia
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  investigator full name: Vito Romano
  investigator title: Professor
  mesh term: Chlorhexidine
  mesh term: Povidone-Iodine
  mesh term: Povidone
  sharing ipd: Yes
  ipd description: IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: After completion of the study
  ipd access criteria: Upon approval of individual sharing request