<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/NCT03833908</url>
  </required_header>
  <id_info>
    <org_study_id>VF-OS-002/2018</org_study_id>
    <nct_id>NCT03833908</nct_id>
  </id_info>
  <brief_title>Evaluation of the Performance of MAF-1217 on Cataract Surgery</brief_title>
  <official_title>Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery</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>
      MAF-1217 is meant as the medical device which is to be effective in most forms of DED;&#xD;
      therefore, it is expected that study patients benefit from study participation, and can&#xD;
      reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery,&#xD;
      in a TID application pre-surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicentre, pre-market, open label, randomized, prospective study exploring the&#xD;
      performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of&#xD;
      post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks&#xD;
      before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery),&#xD;
      and then will be seen at week 1 and 2 after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">June 17, 2019</completion_date>
  <primary_completion_date type="Actual">June 17, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>break-up time (BUT)</measure>
    <time_frame>1 month</time_frame>
    <description>Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>osmolarity</measure>
    <time_frame>1 month</time_frame>
    <description>Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSDI score</measure>
    <time_frame>1 month</time_frame>
    <description>Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in OSDI score.&#xD;
The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer test I</measure>
    <time_frame>1 month</time_frame>
    <description>Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in Schirmer test I (test uses paper strips inserted into the eye for several minutes to measure the production of tears)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>patients receiving MAF-1217</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receiving MAF-1217 from week -2 to week 2 (preand post-surgery, total 4 weeks), standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin for 7 days) from day 0 (post-surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients receiving just standard antibiotic therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients receiving just standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin 7 days) from day 0 (postsurgery).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MAF-1217</intervention_name>
    <description>Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy</description>
    <arm_group_label>patients receiving MAF-1217</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years old patients, male and female&#xD;
&#xD;
          2. Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT&#xD;
             &gt;7&#xD;
&#xD;
          3. Normal to mild DED according to OSDI chart&#xD;
&#xD;
          4. Diagnosis of Cataract requiring surgery&#xD;
&#xD;
          5. Wishing to participate in the study and able to sign the ICF&#xD;
&#xD;
          6. Shirmer test &gt; 15 mm /5'&#xD;
&#xD;
          7. No topic ophthalmic medication, including lubricating eyedrops administration for at&#xD;
             least 4 days before screening visit.&#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. Patients with diagnosis of Glaucoma&#xD;
&#xD;
          3. Functional and anatomic eyelid abnormalities,&#xD;
&#xD;
          4. Complicated cataract,&#xD;
&#xD;
          5. Suture affixing during surgery,&#xD;
&#xD;
          6. Use of artificial tears in the month preceding the study visit&#xD;
&#xD;
          7. Coexisting corneal diseases&#xD;
&#xD;
          8. Autoimmune diseases&#xD;
&#xD;
          9. Past or active cicatricial conjunctivitis&#xD;
&#xD;
         10. Past ocular surface burns&#xD;
&#xD;
         11. Keratinization of the eyelid margin&#xD;
&#xD;
         12. Sjogren syndrome&#xD;
&#xD;
         13. History of corneal trauma&#xD;
&#xD;
         14. Pregnant and lactating women&#xD;
&#xD;
         15. Younger than 18 years old patients&#xD;
&#xD;
         16. Inability to self-administer study medications&#xD;
&#xD;
         17. Known allergic sensitivity to any of the devices ingredients, or any other type of&#xD;
             allergy&#xD;
&#xD;
         18. 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>Università di Firenze, Clinica Oculistica II,</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <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_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>Cataract</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/NCT03833908
org study id: VF-OS-002/2018
nct id: NCT03833908
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
MAF-1217 is meant as the medical device which is to be effective in most forms of DED;
      therefore, it is expected that study patients benefit from study participation, and can
      reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery,
      in a TID application pre-surgery.
This is a multicentre, pre-market, open label, randomized, prospective study exploring the
      performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of
      post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks
      before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery),
      and then will be seen at week 1 and 2 after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: break-up time (BUT)
time frame: 1 month
description: Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)
measure: osmolarity
time frame: 1 month
description: Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity
measure: OSDI score
time frame: 1 month
description: Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in OSDI score.
The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
measure: Schirmer test I
time frame: 1 month
description: Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in Schirmer test I (test uses paper strips inserted into the eye for several minutes to measure the production of tears)
arm group label: patients receiving MAF-1217
arm group type: Experimental
description: patients receiving MAF-1217 from week -2 to week 2 (preand post-surgery, total 4 weeks), standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin for 7 days) from day 0 (post-surgery.
arm group label: patients receiving just standard antibiotic therapy
arm group type: No Intervention
description: patients receiving just standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin 7 days) from day 0 (postsurgery).
intervention type: Device
intervention name: MAF-1217
description: Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy
arm group label: patients receiving MAF-1217
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: Undecided