<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/NCT01684852</url>
  </required_header>
  <id_info>
    <org_study_id>PPL-046</org_study_id>
    <secondary_id>NIS BAT04</secondary_id>
    <nct_id>NCT01684852</nct_id>
  </id_info>
  <brief_title>Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution</brief_title>
  <official_title>Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution (BAT04) Compared to HA Eye Drops in the Treatment of Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bitop AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bitop AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a comparative, open label, parallel group, non interventional study to further&#xD;
      demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall&#xD;
      be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product&#xD;
      according to the instructions for use six times daily in both eyes over a period of 28 days.&#xD;
      Response to treatment is recorded at day 28.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tear Break Up Time</measure>
    <time_frame>V1 and V2</time_frame>
  </primary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical device, drug-like</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic The selection of appropriate patients for the observational study is&#xD;
        made by the individual physician in his treatment decisions in consultation with the&#xD;
        individual patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female person aged 18 years&#xD;
&#xD;
          -  Demonstrated mild to moderate keratoconjunctivitis sicca ( &quot;dry eye&quot;)&#xD;
&#xD;
          -  Acute symptoms of dry eye: DEWS 1-3&#xD;
&#xD;
          -  tear break-up time TBUT &lt;10s&#xD;
&#xD;
          -  agreement to abide by the routinely provided doctor's appointment for follow-up&#xD;
             (reflected in the planned visits of observation plan resist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inflammation of the anterior segment or trauma&#xD;
&#xD;
          -  Contact lens wearers&#xD;
&#xD;
          -  Any disease that can, in the opinion of the treating physician to affect the outcome&#xD;
             of the study.&#xD;
&#xD;
          -  Patients with known intolerance to one of the substances used&#xD;
&#xD;
          -  Surgical procedures to the eyes in the last 6 weeks before inclusion in the trial&#xD;
&#xD;
          -  patients with addictive disorders or substance abuse fallow in the past 12 months, as&#xD;
             well as persons incapable of giving consent&#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>Elisabeth Messmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augenklinik der LMU Klinikum der Universität München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Peter Otto</name>
      <address>
        <city>Bad Liebenwerda</city>
        <zip>04924</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Insa Beddermann</name>
      <address>
        <city>Duderstadt</city>
        <zip>37115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenklinik mit Poliklinik</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenklinik der LMU Klinikum der Universität Muenchen</name>
      <address>
        <city>Muenchen</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenabteilung am St. Franziskus-Hospital Münster</name>
      <address>
        <city>Muenster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>January 29, 2013</last_update_submitted>
  <last_update_submitted_qc>January 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_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/NCT01684852
org study id: PPL-046
secondary id: NIS BAT04
nct id: NCT01684852
lead sponsor: 
has dmc: No
This is a comparative, open label, parallel group, non interventional study to further
      demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall
      be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product
      according to the instructions for use six times daily in both eyes over a period of 28 days.
      Response to treatment is recorded at day 28.
observational model: Case-Control
time perspective: Prospective
measure: Tear Break Up Time
time frame: V1 and V2
intervention type: Other
intervention name: Medical device, drug-like
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elisabeth Messmer, MD
role: Principal Investigator
affiliation: Augenklinik der LMU Klinikum der Universität München
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca