<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/NCT01721694</url>
  </required_header>
  <id_info>
    <org_study_id>AZILOT-12</org_study_id>
    <secondary_id>131.835</secondary_id>
    <nct_id>NCT01721694</nct_id>
  </id_info>
  <brief_title>Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection</brief_title>
  <official_title>Association of Azithromycin 1,5%/Loteprednol 0,5% Eye Drops Versus Individual Administration of Azithromycin 1,5% and Loteprednol 0,5% in the Treatment of Ocular Inflammation and Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adapt Produtos Oftalmológicos Ltda.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adapt Produtos Oftalmológicos Ltda.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5%&#xD;
      Loteprednol eye drops for the treatment of ocular inflammation and infection associated&#xD;
      bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual&#xD;
      administration of azithromycin 1.5% and 0.5% Loteprednol (separately).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Estimated to be admitted a total of approximately 60 patients showing blepharitis and / or&#xD;
      keratitis and / or conjunctivitis: 30 patients will be assigned to the group of Azithromycin&#xD;
      1.5%/Loteprednol 0.5% Eye Drops (fixed combination) + placebo and 30 patients will be&#xD;
      assigned to the group of Azithromycin 1.5% + 0.5% Loteprednol (separately)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    withdrawn by industry&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical cure</measure>
    <time_frame>Day 8</time_frame>
    <description>Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>irradication of pathogens</measure>
    <time_frame>Day 8</time_frame>
    <description>Success obtained with microbiological irradication of pathogens present at baseline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ophthalmic evaluation</measure>
    <time_frame>Day 4 and Day 8</time_frame>
    <description>decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ocular Inflammation</condition>
  <condition>Infection Associated Blepharitis</condition>
  <condition>Keratitis</condition>
  <condition>Conjunctivitis, Bacterial</condition>
  <arm_group>
    <arm_group_label>azithromycin 1.5%/Loteprednol 0,5% + placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fixed combination of azithromycin 1.5% / Loteprednol 0,5% eye drops + placebo eye drops</description>
  </arm_group>
  <arm_group>
    <arm_group_label>azithromycin 1.5% + Loteprednol 0,5% (separately)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin 1.5%/Loteprednol 0,5% + placebo</intervention_name>
    <description>1 drop, AO, QID</description>
    <arm_group_label>azithromycin 1.5%/Loteprednol 0,5% + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin 1.5% + Loteprednol 0,5% (separately)</intervention_name>
    <description>1 drop, QID, AO</description>
    <arm_group_label>azithromycin 1.5% + Loteprednol 0,5% (separately)</arm_group_label>
    <other_name>azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were male or female, of any race and age minimum of 18 years.&#xD;
&#xD;
          -  Blepharitis should provide diagnostic and / or keratitis and / or conjunctivitis with&#xD;
             or without bacterial involvement corneal by biomicroscopy, with positive staining&#xD;
             corneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctival&#xD;
             hyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flaking&#xD;
             eyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intraocular hypertension or uncontrolled glaucoma.&#xD;
&#xD;
          -  Use of contact lenses during the study.&#xD;
&#xD;
          -  Capacity unilateral visual only.&#xD;
&#xD;
          -  Suspected fungal infection, viral (eg, herpes simplex epithelial, dendritic keratitis)&#xD;
             or Acanthamoeba, or any other disease where the use of corticosteroids is&#xD;
             contraindicated.&#xD;
&#xD;
          -  Use of any topical ophthalmic medications preserved during study participation. Not be&#xD;
             allowed eyedrops preserved (eg artificial tears).&#xD;
&#xD;
          -  Use of any antibacterial agent oral or topical ophthalmic until 72 hours prior to&#xD;
             study entry.&#xD;
&#xD;
          -  Use of systemic steroids within 14 days prior to study entry. Ophthalmic topical&#xD;
             steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), until one week before&#xD;
             admission to the study. Will not be allowed to use these medications during study&#xD;
             participation. Will not be allowed to use nasal steroids during the study. Will be&#xD;
             allowed to use inhaled steroids to aid inhaler. Will be allowed steroids dermal&#xD;
             topics.&#xD;
&#xD;
          -  Use of nonsteroidal anti-inflammatory drugs (NSAIDs) systemic up to 24 hours prior to&#xD;
             study entry or at any time during the study, unless the patient is under treatment&#xD;
             regimen with stable (not necessary) for at least 2 months before Admission and therapy&#xD;
             continues throughout the study.&#xD;
&#xD;
          -  Any disturbance or ocular or systemic disease, complicating factors or structural&#xD;
             abnormality that affects the conduct or outcome of the study in a negative way or&#xD;
             represents an undue risk to patient safety, according to the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Any current immunosuppressive disorder (eg, HIV-positive), or immunosuppressive&#xD;
             therapy (including chemotherapy).&#xD;
&#xD;
          -  Known allergy or suspected allergy or hypersensitivity to fluoroquinolones, to&#xD;
             steroids or any other component of the study drug;&#xD;
&#xD;
          -  Pregnant or lactating. (Women of childbearing age may be admitted if they use&#xD;
             contraception and submit urine pregnancy test negative);&#xD;
&#xD;
          -  Any patient who has a family member who participates in this study&#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>Rubens Belfort Jr., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo / Hospital São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology of Hospital São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04023-062</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bacterial ocular inflammation</keyword>
  <keyword>blepharitis</keyword>
  <keyword>keratitis</keyword>
  <keyword>conjunctivitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Conjunctivitis, Bacterial</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Keratitis</mesh_term>
    <mesh_term>Blepharitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</mesh_term>
    <mesh_term>Azithromycin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01721694
org study id: AZILOT-12
secondary id: 131.835
nct id: NCT01721694
lead sponsor: 
has dmc: No
To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5%
      Loteprednol eye drops for the treatment of ocular inflammation and infection associated
      bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual
      administration of azithromycin 1.5% and 0.5% Loteprednol (separately).
Estimated to be admitted a total of approximately 60 patients showing blepharitis and / or
      keratitis and / or conjunctivitis: 30 patients will be assigned to the group of Azithromycin
      1.5%/Loteprednol 0.5% Eye Drops (fixed combination) + placebo and 30 patients will be
      assigned to the group of Azithromycin 1.5% + 0.5% Loteprednol (separately)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Clinical cure
time frame: Day 8
description: Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8)
measure: irradication of pathogens
time frame: Day 8
description: Success obtained with microbiological irradication of pathogens present at baseline
measure: ophthalmic evaluation
time frame: Day 4 and Day 8
description: decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting
arm group label: azithromycin 1.5%/Loteprednol 0,5% + placebo
arm group type: Experimental
description: fixed combination of azithromycin 1.5% / Loteprednol 0,5% eye drops + placebo eye drops
arm group label: azithromycin 1.5% + Loteprednol 0,5% (separately)
arm group type: Active Comparator
description: azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)
intervention type: Drug
intervention name: azithromycin 1.5%/Loteprednol 0,5% + placebo
description: 1 drop, AO, QID
arm group label: azithromycin 1.5%/Loteprednol 0,5% + placebo
intervention type: Drug
intervention name: azithromycin 1.5% + Loteprednol 0,5% (separately)
description: 1 drop, QID, AO
arm group label: azithromycin 1.5% + Loteprednol 0,5% (separately)
other name: azithromycin 1.5% + Loteprednol 0,5% eye drops (separately)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rubens Belfort Jr., MD
role: Principal Investigator
affiliation: Federal University of São Paulo / Hospital São Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Conjunctivitis, Bacterial
mesh term: Conjunctivitis
mesh term: Keratitis
mesh term: Blepharitis
mesh term: Inflammation
mesh term: Loteprednol Etabonate
mesh term: Azithromycin