<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/NCT03833882</url>
  </required_header>
  <id_info>
    <org_study_id>VF-OS-001/2018</org_study_id>
    <nct_id>NCT03833882</nct_id>
  </id_info>
  <brief_title>Evaluation of MAF-1217 in Patients With DED</brief_title>
  <official_title>Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VISUfarma SpA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VISUfarma SpA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pre-market, multicentre, double-blind, randomized, crossover, non-inferiority study&#xD;
      comparing the efficacy of MAF-1217 and Cationorm® in adult patients with evaporative DED.&#xD;
&#xD;
      The study population will be divided in 4 different subgroups, according to the different&#xD;
      types of evaporative DED:&#xD;
&#xD;
        1. Group A: high evaporative levels&#xD;
&#xD;
        2. Group B: females in menopause, whether using hormonal integration or not&#xD;
&#xD;
        3. Group C: presence of active obstructive Meibomian gland disease&#xD;
&#xD;
        4. Group D: glaucomatous patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be enrolled after having signed the informed consent form prior any other study&#xD;
      procedure and after inclusion/exclusion criteria check.&#xD;
&#xD;
      Each patient will be planned to perform 6 study visits and at each visit all necessary study&#xD;
      procedures will be performed according to the clinical investigation plan requirements (see&#xD;
      flow-chart).&#xD;
&#xD;
      The study visits will be performed at: screening, baseline, week 2, week 6, week 8, week 12.&#xD;
&#xD;
      Patients will be enrolled at screening visit and at baseline, after the wash-out period of 1&#xD;
      week, then will be randomized to receive MAF-1217 or Cationorm® for the following 6 weeks.&#xD;
&#xD;
      After this time lapse, patients will be switched to the opposite therapy for 6 additional&#xD;
      weeks.&#xD;
&#xD;
      The entire study population will be asked for a TID posology, and will be divided in 4&#xD;
      different subgroups, according to the different types of evaporative DED.&#xD;
&#xD;
      Certain test will be performed only in some patients:&#xD;
&#xD;
      Osmolimetry and tear sampling in 20 patients(10/site) chosen random from groups B, C and D;&#xD;
      Ferning test only in group D; tear film collection and cytokine expression only in 20&#xD;
      patients form site nr. 2.&#xD;
&#xD;
      Patients will be allowed to carry on any systemic or local medications, apart lubricating&#xD;
      eyedrops, which have to be stopped the day before baseline visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">June 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 2019</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Break-up time (BUT) differences</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Changes in break-up time (BUT) versus baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ocular surface staining (corneal and conjunctival)</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Cross-over analysis for the differences versus baseline between the two groups on changes in ocular surface staining (corneal and conjunctival)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer I test (ST) (without anesthesia)</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Cross-over analysis for the differences versus baseline between the two groups on changes in Schirmer I test (ST) (without anesthesia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of blinking per minute</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Cross-over analysis for the differences versus baseline between the two groups on changes in number of blinking per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferning test (Group D)</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>osmolarity</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction (10 points VAS scale)</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment versus baseline</time_frame>
    <description>Cross-over analysis for the differences versus baseline between the two groups on changes in patient satisfaction (10 points VAS scale).&#xD;
(VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSDI</measure>
    <time_frame>measured at week 2, 6, 8 and 12 weeks treatment</time_frame>
    <description>Changes in questionnaire scores (OSDI - Ocular Surface Disease Index). The overall Ocular Surface Disease score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Evaporative Dry Eye Disease</condition>
  <arm_group>
    <arm_group_label>MAF1217/Cationorm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cationorm/MAF1217</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MAF1217</intervention_name>
    <description>The study population will have to self-administer the study treatment in a TID posology.</description>
    <arm_group_label>Cationorm/MAF1217</arm_group_label>
    <arm_group_label>MAF1217/Cationorm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cationorm</intervention_name>
    <description>The study population will have to self-administer the study treatment in a TID posology.</description>
    <arm_group_label>Cationorm/MAF1217</arm_group_label>
    <arm_group_label>MAF1217/Cationorm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years old (adult patients), male and female&#xD;
&#xD;
          2. Schirmer I test &gt; 10 mm at 5'&#xD;
&#xD;
          3. (Group A): high evaporative levels&#xD;
&#xD;
          4. (Group B): females in menopause, both using hormonal integration or not&#xD;
&#xD;
          5. (Group C): presence of active obstructive Meibomian gland disease, defined as at least&#xD;
             one of the following:&#xD;
&#xD;
               -  Meibomian orifice plugging&#xD;
&#xD;
               -  eyelid margin foaminess&#xD;
&#xD;
               -  changes in orifice position with respect to the mucocutaneous junction&#xD;
&#xD;
               -  abnormal Meibomian gland secretions (opaque and viscous-like form that is&#xD;
                  difficult to express)&#xD;
&#xD;
          6. (Group D): glaucomatous patients receiving one or more BAK preserved treatments for at&#xD;
             least 2 years, showing an abnormal Ferning test (Types 3 or 4 according to Rolando)&#xD;
&#xD;
          7. all: wishing to participate in the study and able to sign the ICF&#xD;
&#xD;
        Inclusion criteria to be checked at baseline:&#xD;
&#xD;
          1. BUT &lt; 7&quot;&#xD;
&#xD;
          2. Mild to severe DED according to OSDI chart&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous&#xD;
             ocular herpes infections)&#xD;
&#xD;
          2. Coexisting corneal diseases&#xD;
&#xD;
          3. Autoimmune diseases&#xD;
&#xD;
          4. Past or active cicatricial conjunctivitis&#xD;
&#xD;
          5. Past ocular surface burns&#xD;
&#xD;
          6. Keratinization of the eyelid margin&#xD;
&#xD;
          7. Sjogren syndrome&#xD;
&#xD;
          8. History of corneal trauma&#xD;
&#xD;
          9. Pregnant and lactating women&#xD;
&#xD;
         10. Younger than 18 years old patients&#xD;
&#xD;
         11. Use of contact lenses&#xD;
&#xD;
         12. inability to self administer study medications&#xD;
&#xD;
         13. (GROUPS B, D) Presence of active obstructive Meibomian gland disease&#xD;
&#xD;
         14. (GROUP C) Presence of cicatricial Meibomian gland disease&#xD;
&#xD;
         15. known allergic sensitivity to any of the devices ingredients or any other known&#xD;
             allergy&#xD;
&#xD;
         16. participation in a clinical trial during the 3 months prior to the beginning of the&#xD;
             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>Ospedale San Paolo, ASST Santi Paolo e Carlo</name>
      <address>
        <city>Milan</city>
        <zip>20121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Fatebenefratelli Sacco P.O.L. Sacco</name>
      <address>
        <city>Milan</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>July 12, 2019</last_update_submitted>
  <last_update_submitted_qc>July 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03833882
org study id: VF-OS-001/2018
nct id: NCT03833882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pre-market, multicentre, double-blind, randomized, crossover, non-inferiority study
      comparing the efficacy of MAF-1217 and Cationorm® in adult patients with evaporative DED.

      The study population will be divided in 4 different subgroups, according to the different
      types of evaporative DED:

        1. Group A: high evaporative levels

        2. Group B: females in menopause, whether using hormonal integration or not

        3. Group C: presence of active obstructive Meibomian gland disease

        4. Group D: glaucomatous patients
Patients will be enrolled after having signed the informed consent form prior any other study
      procedure and after inclusion/exclusion criteria check.

      Each patient will be planned to perform 6 study visits and at each visit all necessary study
      procedures will be performed according to the clinical investigation plan requirements (see
      flow-chart).

      The study visits will be performed at: screening, baseline, week 2, week 6, week 8, week 12.

      Patients will be enrolled at screening visit and at baseline, after the wash-out period of 1
      week, then will be randomized to receive MAF-1217 or Cationorm® for the following 6 weeks.

      After this time lapse, patients will be switched to the opposite therapy for 6 additional
      weeks.

      The entire study population will be asked for a TID posology, and will be divided in 4
      different subgroups, according to the different types of evaporative DED.

      Certain test will be performed only in some patients:

      Osmolimetry and tear sampling in 20 patients(10/site) chosen random from groups B, C and D;
      Ferning test only in group D; tear film collection and cytokine expression only in 20
      patients form site nr. 2.

      Patients will be allowed to carry on any systemic or local medications, apart lubricating
      eyedrops, which have to be stopped the day before baseline visit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Break-up time (BUT) differences
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Changes in break-up time (BUT) versus baseline
measure: ocular surface staining (corneal and conjunctival)
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Cross-over analysis for the differences versus baseline between the two groups on changes in ocular surface staining (corneal and conjunctival)
measure: Schirmer I test (ST) (without anesthesia)
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Cross-over analysis for the differences versus baseline between the two groups on changes in Schirmer I test (ST) (without anesthesia)
measure: number of blinking per minute
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Cross-over analysis for the differences versus baseline between the two groups on changes in number of blinking per minute
measure: Ferning test (Group D)
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D)
measure: osmolarity
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity
measure: patient satisfaction (10 points VAS scale)
time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
description: Cross-over analysis for the differences versus baseline between the two groups on changes in patient satisfaction (10 points VAS scale).
(VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level).
measure: OSDI
time frame: measured at week 2, 6, 8 and 12 weeks treatment
description: Changes in questionnaire scores (OSDI - Ocular Surface Disease Index). The overall Ocular Surface Disease score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
arm group label: MAF1217/Cationorm
arm group type: Experimental
arm group label: Cationorm/MAF1217
arm group type: Experimental
intervention type: Device
intervention name: MAF1217
description: The study population will have to self-administer the study treatment in a TID posology.
arm group label: Cationorm/MAF1217
arm group label: MAF1217/Cationorm
intervention type: Other
intervention name: Cationorm
description: The study population will have to self-administer the study treatment in a TID posology.
arm group label: Cationorm/MAF1217
arm group label: MAF1217/Cationorm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Eye Diseases
mesh term: Keratoconjunctivitis Sicca
sharing ipd: Undecided