<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/NCT03301844</url>
  </required_header>
  <id_info>
    <org_study_id>BLEPHA 01-2017</org_study_id>
    <nct_id>NCT03301844</nct_id>
  </id_info>
  <brief_title>To Compare Blephapad Combo vs Standard Treatment for Eyelid Cleansing in Bilateral Posterior Blepharitis</brief_title>
  <official_title>Randomized, Controlled Study With a Closed Sequential Design to Compare the Efficacy, Safety and Patient Satisfaction of Blephapad Combo vs. Standard Treatment for Eyelid Cleansing in Patients Affected by Bilateral Posterior Blepharitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NTC srl</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NTC srl</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>
      The purpose of this study is to evaluate the efficacy of, and patient satisfaction with&#xD;
      Blephapad Combo in the treatment of posterior blepharitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blepharitis is the most common condition in patients seeking an eye examination due to&#xD;
      discomfort or eye irritation. Treatment of blepharitis is recommended even in mild cases as&#xD;
      chronic inflammation may cause permanent damage to the Meibomian glands.&#xD;
&#xD;
      Each eye of each patient represents an experimental unit. Each patient will apply Blephapad&#xD;
      Combo to one eye and standard treatment to the other eye in accordance with the randomization&#xD;
      procedure.&#xD;
&#xD;
      The aim of this randomized, controlled study with a closed sequential design is to evaluate&#xD;
      versus standard treatment the efficacy of, and patient satisfaction with Blephapad Combo in&#xD;
      the treatment of posterior blepharitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">February 9, 2018</completion_date>
  <primary_completion_date type="Actual">February 9, 2018</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>Sequential Assignment</intervention_model>
    <intervention_model_description>A randomized, controlled study with a closed sequential design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)</measure>
    <time_frame>from baseline to week 4</time_frame>
    <description>The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome.&#xD;
The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)</measure>
    <time_frame>From Visit 2 (baseline) to Visit 3 (week 4)</time_frame>
    <description>For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes:&#xD;
Eye on Blephapad Combo: Improved-Eye on Standard: Improved&#xD;
Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved&#xD;
Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved&#xD;
Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved&#xD;
The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as &quot;NOT improved&quot;,on the contrary if the change of the total score resulted negative the specific eye was referred as &quot;Improved&quot;. For each patient the results on the two eyes were combined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)</measure>
    <time_frame>at Visit 3 (week 4)</time_frame>
    <description>At the end of study patients was asked to state their preference on the treatments used.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Ocular Adverse Events Reported Throughout the Study</measure>
    <time_frame>From Visit 2 (baseline) to Visit 3 (week 4)</time_frame>
    <description>A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study</description>
  </other_outcome>
  <other_outcome>
    <measure>Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes</measure>
    <time_frame>From Visit 2 (baseline) to Visit 3 (week 4)</time_frame>
    <description>Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze.&#xD;
The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied:&#xD;
(Given wipes/gauze - (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the &quot;given wipes/gauze&quot; were 60 and the &quot;expected number of wipes/gauze used&quot; were 2 per days per 4 weeks = 56.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Bilateral Blepharitis (Disorder)</condition>
  <arm_group>
    <arm_group_label>Study treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Wet, warm gauze twice daily for one month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Blephapad Combo</intervention_name>
    <description>Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
    <arm_group_label>Study treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
    <arm_group_label>Standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 40 years&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Diagnosis of bilateral posterior blepharitis&#xD;
&#xD;
          -  Written informed consent of patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with topical ophthalmic drugs (artificial tears allowed)&#xD;
&#xD;
          -  Ocular surgery in the previous 6 months&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Cognitive impairment that could affect evaluation of preferences&#xD;
&#xD;
          -  Participation in other clinical studies in the last month&#xD;
&#xD;
          -  Hypersensitivity to one or more components of the study products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincenzo Scorcia</last_name>
    <role>Principal Investigator</role>
    <affiliation>A.O.U. Policlinico Mater Domini</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>A.O.U. Policlinico Mater Domini</name>
      <address>
        <city>Catanzaro</city>
        <state>CZ</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>September 10, 2019</results_first_submitted>
  <results_first_submitted_qc>November 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2019</results_first_posted>
  <last_update_submitted>November 29, 2019</last_update_submitted>
  <last_update_submitted_qc>November 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 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>Blepharitis</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03301844/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were enrolled between May 2017 and January 2018 at the Ophthalmology Unit of the Magna Graecia University of Catanzaro in Italy</recruitment_details>
      <pre_assignment_details>During a 2-week run-in period starting at Visit 1, and after the patient has provided informed consent, the Investigator will collect demographic data and medical history and perform a physical examination of the patient.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Study Treatment</title>
          <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
        </group>
        <group group_id="P2">
          <title>Standard Treatment</title>
          <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19">Each patient apply the Blephapad Combo wipes to one eye and standard treatment to the other eye.</participants>
                <participants group_id="P2" count="19">Each patient apply the Blephapad Combo wipes to one eye and standard treatment to the other eye.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>suspected colon cancer</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients aged &gt; 40 years with symmetrical bilateral posterior blepharitis. Each eye represented a single experimental unit.</population>
      <group_list>
        <group group_id="B1">
          <title>Study Treatment</title>
          <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
        </group>
        <group group_id="B2">
          <title>Standard Treatment</title>
          <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>One patient was excluded due to suspected colon cancer.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>One patient was excluded due to suspected colon cancer.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.9" spread="9.03"/>
                    <measurement group_id="B2" value="66.9" spread="9.03"/>
                    <measurement group_id="B3" value="66.9" spread="9.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>One patient was excluded due to suspected colon cancer</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>One patient was excluded due to suspected colon cancer.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>One patient was excluded due to suspected colon cancer.</population>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Meibomian Gland Dysfunction (MGD) at baseline (visit 2)</title>
          <description>The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15. The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands. Higher scores implied a worse meibomian gland condition while lower scores were correlated to a better condition.</description>
          <population>One patient was excluded due to suspected colon cancer.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.17" spread="2.64"/>
                    <measurement group_id="B2" value="9.39" spread="2.73"/>
                    <measurement group_id="B3" value="9.28" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)</title>
        <description>The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome.&#xD;
The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features.</description>
        <time_frame>from baseline to week 4</time_frame>
        <population>patients with symmetrical bilateral posterior blepharitis</population>
        <group_list>
          <group group_id="O1">
            <title>Study Treatment</title>
            <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment</title>
            <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)</title>
          <description>The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome.&#xD;
The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features.</description>
          <population>patients with symmetrical bilateral posterior blepharitis</population>
          <units>percentage of change in the total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.5" spread="21.3"/>
                    <measurement group_id="O2" value="-29.9" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)</title>
        <description>For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes:&#xD;
Eye on Blephapad Combo: Improved-Eye on Standard: Improved&#xD;
Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved&#xD;
Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved&#xD;
Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved&#xD;
The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as &quot;NOT improved&quot;,on the contrary if the change of the total score resulted negative the specific eye was referred as &quot;Improved&quot;. For each patient the results on the two eyes were combined.</description>
        <time_frame>From Visit 2 (baseline) to Visit 3 (week 4)</time_frame>
        <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Treatment</title>
            <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment</title>
            <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)</title>
          <description>For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes:&#xD;
Eye on Blephapad Combo: Improved-Eye on Standard: Improved&#xD;
Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved&#xD;
Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved&#xD;
Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved&#xD;
The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as &quot;NOT improved&quot;,on the contrary if the change of the total score resulted negative the specific eye was referred as &quot;Improved&quot;. For each patient the results on the two eyes were combined.</description>
          <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Eye improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Eye NOT improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)</title>
        <description>At the end of study patients was asked to state their preference on the treatments used.</description>
        <time_frame>at Visit 3 (week 4)</time_frame>
        <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint. One patient didn't express the preference therefore 17 patients were considered.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Treatment</title>
            <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment</title>
            <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)</title>
          <description>At the end of study patients was asked to state their preference on the treatments used.</description>
          <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint. One patient didn't express the preference therefore 17 patients were considered.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.071</p_value>
            <method>Chi-squared</method>
            <other_analysis_desc>Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.&#xD;
Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Ocular Adverse Events Reported Throughout the Study</title>
        <description>A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study</description>
        <time_frame>From Visit 2 (baseline) to Visit 3 (week 4)</time_frame>
        <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.&#xD;
One patient reported a treatment-emergent systemic adverse event, i.e. &quot;Suspected colon cancer&quot; of mild severity that led to permanent treatment discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Treatment</title>
            <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment</title>
            <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Ocular Adverse Events Reported Throughout the Study</title>
          <description>A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study</description>
          <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.&#xD;
One patient reported a treatment-emergent systemic adverse event, i.e. &quot;Suspected colon cancer&quot; of mild severity that led to permanent treatment discontinuation.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eyes with Serious Ocular Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eyes with Ocular Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7353</p_value>
            <method>Chi-squared</method>
            <other_analysis_desc>The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.&#xD;
Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes</title>
        <description>Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze.&#xD;
The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied:&#xD;
(Given wipes/gauze - (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the &quot;given wipes/gauze&quot; were 60 and the &quot;expected number of wipes/gauze used&quot; were 2 per days per 4 weeks = 56.</description>
        <time_frame>From Visit 2 (baseline) to Visit 3 (week 4)</time_frame>
        <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Treatment</title>
            <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment</title>
            <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes</title>
          <description>Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze.&#xD;
The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied:&#xD;
(Given wipes/gauze - (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the &quot;given wipes/gauze&quot; were 60 and the &quot;expected number of wipes/gauze used&quot; were 2 per days per 4 weeks = 56.</description>
          <population>Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.</population>
          <units>percentage of Application (Wet Wipes)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.1" spread="8.8"/>
                    <measurement group_id="O2" value="94.2" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from baseline to week 4</time_frame>
      <desc>The patient will be given a diary on which to record the application of all morning and evening treatments, as well as any adverse events occurred. The diary is to be returned at Visit 3 for review</desc>
      <group_list>
        <group group_id="E1">
          <title>Study Treatment</title>
          <description>Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.&#xD;
Blephapad Combo: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.&#xD;
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.</description>
        </group>
        <group group_id="E2">
          <title>Standard Treatment</title>
          <description>Wet, warm gauze twice daily for one month.&#xD;
Standard treatment: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Ocular pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Irritation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Itching or discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Increased lacrimation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Ocular secretions</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Crusts on eyelid margins</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Purulent discharge</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Madarosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alessandro Colombo</name_or_title>
      <organization>NTC srl</organization>
      <phone>+39 02 4385 0490</phone>
      <email>alessandro.colombo@ntcpharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03301844
org study id: BLEPHA 01-2017
nct id: NCT03301844
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of, and patient satisfaction with
      Blephapad Combo in the treatment of posterior blepharitis.
Blepharitis is the most common condition in patients seeking an eye examination due to
      discomfort or eye irritation. Treatment of blepharitis is recommended even in mild cases as
      chronic inflammation may cause permanent damage to the Meibomian glands.

      Each eye of each patient represents an experimental unit. Each patient will apply Blephapad
      Combo to one eye and standard treatment to the other eye in accordance with the randomization
      procedure.

      The aim of this randomized, controlled study with a closed sequential design is to evaluate
      versus standard treatment the efficacy of, and patient satisfaction with Blephapad Combo in
      the treatment of posterior blepharitis.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: A randomized, controlled study with a closed sequential design
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)
time frame: from baseline to week 4
description: The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome.
The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features.
measure: Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)
time frame: From Visit 2 (baseline) to Visit 3 (week 4)
description: For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes:
Eye on Blephapad Combo: Improved-Eye on Standard: Improved
Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved
Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved
Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved
The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as "NOT improved",on the contrary if the change of the total score resulted negative the specific eye was referred as "Improved". For each patient the results on the two eyes were combined.
measure: Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)
time frame: at Visit 3 (week 4)
description: At the end of study patients was asked to state their preference on the treatments used.
measure: Incidence of Ocular Adverse Events Reported Throughout the Study
time frame: From Visit 2 (baseline) to Visit 3 (week 4)
description: A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study
measure: Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes
time frame: From Visit 2 (baseline) to Visit 3 (week 4)
description: Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze.
The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied:
(Given wipes/gauze - (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the "given wipes/gauze" were 60 and the "expected number of wipes/gauze used" were 2 per days per 4 weeks = 56.
arm group label: Study treatment
arm group type: Experimental
description: Blephapad Combo twice daily for one month. Blephapad is a disposable wet wipe containing Hy-Ter® solution (sodium hyaluronate acid and 4-terpineol), aloe, natural anti-inflammatories and antiseptics.
arm group label: Standard treatment
arm group type: Other
description: Wet, warm gauze twice daily for one month.
intervention type: Combination Product
intervention name: Blephapad Combo
description: Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.
The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes.
arm group label: Study treatment
intervention type: Other
intervention name: Standard treatment
description: Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
arm group label: Standard treatment
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Vincenzo Scorcia
role: Principal Investigator
affiliation: A.O.U. Policlinico Mater Domini
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Blepharitis
mesh term: Meibomian Gland Dysfunction
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 