<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/NCT02986750</url>
  </required_header>
  <id_info>
    <org_study_id>LT2258-PIV-0216</org_study_id>
    <nct_id>NCT02986750</nct_id>
  </id_info>
  <brief_title>Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms 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. Topically administered lubricants are the basis for treatment of this&#xD;
      disease. However, exact information about influence on tear film thickness and corneal&#xD;
      residence time of topical lubricants is still sparse, therefore no ideal treatment regimen&#xD;
      has been found.&#xD;
&#xD;
      Recently a new method for assessment of tear film thickness based on ultra-high resolution&#xD;
      optical coherence tomography (OCT) has become available. The aim of the present study is to&#xD;
      assess the influence on tear film thickness of three different formulations of topical&#xD;
      lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye&#xD;
      Drops in patients with moderate to severe dry eye disease. In addition, standard tests for&#xD;
      dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal&#xD;
      fluorescein staining and determination of tear break up time (BUT) will be performed to&#xD;
      compare the product effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2016</start_date>
  <completion_date type="Actual">March 23, 2017</completion_date>
  <primary_completion_date type="Actual">March 23, 2017</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in tear film thickness as measured with Optical Coherence Tomography (OCT)</measure>
    <time_frame>10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation</time_frame>
    <description>Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tear Break Up Time (BUT)</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective evaluation of ocular comfort with questionnaire</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer I test</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSDI score</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal fluorescein staining (Oxford grading scale)</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival hyperemia score</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessment of eye drops by the patient with questionnaire</measure>
    <time_frame>10 weeks</time_frame>
    <description>Efficacy of eye drops will be performed by the patient by choosing one of the following options:&#xD;
Very satisfactory&#xD;
Satisfactory&#xD;
Not very satisfactory&#xD;
Unsatisfactory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy assessment of eye drops by the investigator with questionnaire</measure>
    <time_frame>10 weeks</time_frame>
    <description>Efficacy of eye drops will be performed by the investigator by choosing one of the following options:&#xD;
Very satisfactory&#xD;
Satisfactory&#xD;
Not very satisfactory&#xD;
Unsatisfactory</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</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>40 Patients with dry eye syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Patients with dry eye syndrome 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 Patients with dry eye syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Patients with dry eye syndrome 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 Patients with dry eye syndrome</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thealoz Duo Eye Drops</intervention_name>
    <description>Manufacturer: Laboratoires Thea, France</description>
    <arm_group_label>Experimental: Patients with dry eye syndrome 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optive Eye Drops</intervention_name>
    <description>Manufacturer: Allergan Pharmaceuticals, Ireland</description>
    <arm_group_label>Experimental: Patients with dry eye syndrome 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Systane Ultra Eye Drops</intervention_name>
    <description>Manufacturer: Alcon Pharma GmbH</description>
    <arm_group_label>Experimental: Patients with dry eye syndrome 3</arm_group_label>
  </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, ametropia &lt; 6 Dpt.&#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 study&#xD;
             medications or Fluorescein.&#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, haematological 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 sterilised.&#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;
&#xD;
         12. Subject is a ward of court.&#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>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 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/NCT02986750
org study id: LT2258-PIV-0216
nct id: NCT02986750
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. However, exact information about influence on tear film thickness and corneal
      residence time of topical lubricants is still sparse, therefore no ideal treatment regimen
      has been found.

      Recently a new method for assessment of tear film thickness based on ultra-high resolution
      optical coherence tomography (OCT) has become available. The aim of the present study is to
      assess the influence on tear film thickness of three different formulations of topical
      lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye
      Drops in patients with moderate to severe dry eye disease. In addition, standard tests for
      dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal
      fluorescein staining and determination of tear break up time (BUT) will be performed to
      compare the product effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Change in tear film thickness as measured with Optical Coherence Tomography (OCT)
time frame: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation
description: Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day
measure: Tear Break Up Time (BUT)
time frame: 10 weeks
measure: Subjective evaluation of ocular comfort with questionnaire
time frame: 10 weeks
measure: Schirmer I test
time frame: 10 weeks
measure: OSDI score
time frame: 10 weeks
measure: Corneal fluorescein staining (Oxford grading scale)
time frame: 10 weeks
measure: Conjunctival hyperemia score
time frame: 10 weeks
measure: Efficacy assessment of eye drops by the patient with questionnaire
time frame: 10 weeks
description: Efficacy of eye drops will be performed by the patient by choosing one of the following options:
Very satisfactory
Satisfactory
Not very satisfactory
Unsatisfactory
measure: Efficacy assessment of eye drops by the investigator with questionnaire
time frame: 10 weeks
description: Efficacy of eye drops will be performed by the investigator by choosing one of the following options:
Very satisfactory
Satisfactory
Not very satisfactory
Unsatisfactory
arm group label: Experimental: Patients with dry eye syndrome 1
arm group type: Experimental
description: 40 Patients with dry eye syndrome
arm group label: Experimental: Patients with dry eye syndrome 2
arm group type: Active Comparator
description: 40 Patients with dry eye syndrome
arm group label: Experimental: Patients with dry eye syndrome 3
arm group type: Active Comparator
description: 40 Patients with dry eye syndrome
intervention type: Device
intervention name: Thealoz Duo Eye Drops
description: Manufacturer: Laboratoires Thea, France
arm group label: Experimental: Patients with dry eye syndrome 1
intervention type: Device
intervention name: Optive Eye Drops
description: Manufacturer: Allergan Pharmaceuticals, Ireland
arm group label: Experimental: Patients with dry eye syndrome 2
intervention type: Device
intervention name: Systane Ultra Eye Drops
description: Manufacturer: Alcon Pharma GmbH
arm group label: Experimental: Patients with dry eye syndrome 3
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