<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/NCT02980913</url>
  </required_header>
  <id_info>
    <org_study_id>LT 2258-PIV-05/15</org_study_id>
    <nct_id>NCT02980913</nct_id>
  </id_info>
  <brief_title>Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the&#xD;
      elderly population.&#xD;
&#xD;
      Topically administered lubricants are the basis for treatment of this disease. Relief of&#xD;
      symptoms in patients with moderate to severe dry eye disease is usually reached by the use of&#xD;
      artificial tears during the day. Nighttime relief is often achieved by substances known to be&#xD;
      more adhesive to the ocular surface, such as gels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2016</start_date>
  <completion_date type="Actual">May 17, 2016</completion_date>
  <primary_completion_date type="Actual">May 17, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tear Break Up Time (BUT)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer I test</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival and corneal staining</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSDI questionnaire</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients (VAS)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>Experimental: Patients with dry eye syndrome 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Patients with dry eye syndrome 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thealoz Duo eye drops and Thealoz Duo gel</intervention_name>
    <description>Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days</description>
    <arm_group_label>Experimental: Patients with dry eye syndrome 1</arm_group_label>
    <arm_group_label>Experimental: Patients with dry eye syndrome 2</arm_group_label>
    <other_name>Intervention 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thealoz Duo gel</intervention_name>
    <description>Thealoz Duo gel during the day and at night for 7 days</description>
    <arm_group_label>Experimental: Patients with dry eye syndrome 1</arm_group_label>
    <arm_group_label>Experimental: Patients with dry eye syndrome 2</arm_group_label>
    <other_name>Intervention 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged over 18 years&#xD;
&#xD;
          2. Signed and dated written informed consent.&#xD;
&#xD;
          3. History of dry eye syndrome for at least 3 months&#xD;
&#xD;
          4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm&#xD;
&#xD;
          5. OSDI ≥ 22&#xD;
&#xD;
          6. Normal ophthalmic findings except dry eye syndrome&#xD;
&#xD;
          7. No administration of topical lubricants 24 hours before the screening examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of an ocular pathology judged by the investigator as incompatible with the&#xD;
             study.&#xD;
&#xD;
          2. Any other clinical relevant ocular abnormality except DES.&#xD;
&#xD;
          3. History of allergy, known hypersensitivity to one of the components: the administered&#xD;
             medical device product, fluorescein or lissamine green&#xD;
&#xD;
          4. History of known clinically relevant allergy&#xD;
&#xD;
          5. Medical or surgical history judged by the investigator to be incompatible with the&#xD;
             study participation (hepatic or renal insufficiency; all chronic severe organic&#xD;
             disease: metabolic, endocrine, neoplasic, hematological disease; severe psychiatric&#xD;
             illness, etc.).&#xD;
&#xD;
          6. History of a recent acute illness with a recovery period within the 2 weeks before the&#xD;
             inclusion visit (Day 0).&#xD;
&#xD;
          7. Pregnancy, lactation.&#xD;
&#xD;
          8. Pre-menopausal woman who is not using a reliable birth control method (oral&#xD;
             contraceptives or coil) or is not surgically sterilized.&#xD;
&#xD;
          9. Participation in any high-speed or water-sports during the study without ocular&#xD;
             protection (goggles or glasses).&#xD;
&#xD;
         10. Subject unable to understand the study instructions or unlikely to comply with the&#xD;
             study schedule and treatment.&#xD;
&#xD;
         11. Participation in another clinical study in the 4 weeks before the start of the present&#xD;
             study or at the same time as the present 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>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>August 21, 2019</last_update_submitted>
  <last_update_submitted_qc>August 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Gerhard Garhofer</investigator_full_name>
    <investigator_title>Assoc. Prof. PD Dr.</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</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/NCT02980913
org study id: LT 2258-PIV-05/15
nct id: NCT02980913
lead sponsor: 
has dmc: No
Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the
      elderly population.

      Topically administered lubricants are the basis for treatment of this disease. Relief of
      symptoms in patients with moderate to severe dry eye disease is usually reached by the use of
      artificial tears during the day. Nighttime relief is often achieved by substances known to be
      more adhesive to the ocular surface, such as gels.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)
time frame: 4 weeks
description: Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)
measure: Tear Break Up Time (BUT)
time frame: 4 weeks
measure: Schirmer I test
time frame: 4 weeks
measure: Conjunctival and corneal staining
time frame: 4 weeks
measure: OSDI questionnaire
time frame: 4 weeks
measure: Quality of life of patients (VAS)
time frame: 4 weeks
arm group label: Experimental: Patients with dry eye syndrome 1
arm group type: Experimental
description: 20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2
arm group label: Experimental: Patients with dry eye syndrome 2
arm group type: Experimental
description: 20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
intervention type: Device
intervention name: Thealoz Duo eye drops and Thealoz Duo gel
description: Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days
arm group label: Experimental: Patients with dry eye syndrome 1
arm group label: Experimental: Patients with dry eye syndrome 2
other name: Intervention 1
intervention type: Device
intervention name: Thealoz Duo gel
description: Thealoz Duo gel during the day and at night for 7 days
arm group label: Experimental: Patients with dry eye syndrome 1
arm group label: Experimental: Patients with dry eye syndrome 2
other name: Intervention 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Gerhard Garhofer
investigator title: Assoc. Prof. PD Dr.
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Syndrome
mesh term: Ophthalmic Solutions