<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/NCT04485533</url>
  </required_header>
  <id_info>
    <org_study_id>VF-OS-004/2019</org_study_id>
    <nct_id>NCT04485533</nct_id>
  </id_info>
  <brief_title>Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED</brief_title>
  <official_title>Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study</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 post-market, european multicenter study. This is a randomized, cross-over, double&#xD;
      blind study with competitive enrolment, aimed to enroll a total of 90 patients with a&#xD;
      diagnosis of moderate dry eye disease (DED).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to evaluate the non-inferiority of the new treatment versus the&#xD;
      comparator.&#xD;
&#xD;
      Patients, after signing the Informed Consent, will enter into a 1-week screening phase during&#xD;
      which the baseline tests will be conducted.&#xD;
&#xD;
      Baseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment.&#xD;
&#xD;
      Between V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic&#xD;
      evaluations listed in the Flow-Chart will be performed on both eyes of the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>Tear Break-Up Time (TBUT)</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the effect of treatment with VisuXL® GEL versus HYLO® on the stability of the tear film by Tear Break-Up Time (TBUT) in patients affected by moderate dry eye disease (DED).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Stability of the tear film</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Visual Acuity (FVA)</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Functional Visual Acuity (FVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear secretion</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Tear secretion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Burning, foreign body sensation, itching, and photophobia symptoms of DED.&#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>Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal inflammation assessed by staining grade with SICCA Scale</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Each of the three modules that are part of IDEEL questionnaire</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Each of the three modules that are part of IDEEL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way</measure>
    <time_frame>through study completion, an average of 2.5 months</time_frame>
    <description>To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Medical devices' safety and tolerability:&#xD;
Allergy to any device compound&#xD;
Any other adverse event (AE)&#xD;
Adverse device effects (ADEs) -Undetected/unforeseen manufacturing ADE which might bring to application procedure errors -&#xD;
Contamination of the device nozzle and possibility to contaminate both eyes&#xD;
Interaction with any other permitted local administered therapy&#xD;
Vital signs: blood pressure (BP), heart rate (HR), respiratory rate (RR)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>VisuXL® Gel/HYLO®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with VisuXL® ophthalmic gel for the first 30 days (1 treatment period) and with HYLO® for the second 30 days (2 treatment period).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HYLO®/VisuXL® Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients treated with HYLO® for the first 30 days (1 treatment period) and with VisuXL® ophthalmic gel for the second 30 days (2 treatment period).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VisuXL® Gel</intervention_name>
    <description>VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose.&#xD;
Dose/dosage: 1 drop per eye twice a day.</description>
    <arm_group_label>HYLO®/VisuXL® Gel</arm_group_label>
    <arm_group_label>VisuXL® Gel/HYLO®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HYLO®</intervention_name>
    <description>HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water.&#xD;
Dose/dosage: 1 drop per eye twice a day</description>
    <arm_group_label>HYLO®/VisuXL® Gel</arm_group_label>
    <arm_group_label>VisuXL® Gel/HYLO®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient Informed consent form (ICF) signed.&#xD;
&#xD;
          -  Males and Females aged ≥18 years at the time of the signature of ICF.&#xD;
&#xD;
          -  Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score&#xD;
             ≥51 and ≤64) and diagnosed at least 3 months before enrolment.&#xD;
&#xD;
          -  No use of other tear substitutes in the 5 days prior to enrolment, except for refresh&#xD;
             solutions.&#xD;
&#xD;
          -  TBUT value &lt;6 sec.&#xD;
&#xD;
          -  Willing to follow all study procedures, including attending all site visits, tests and&#xD;
             examinations.&#xD;
&#xD;
          -  Women must agree to be using two forms of effective contraception, be post-menopausal&#xD;
             from at least 12 months prior to trial entry, or surgically sterile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire&#xD;
             (score ≤50 and ≥65, respectively).&#xD;
&#xD;
          -  Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh&#xD;
             solutions and stable glaucoma treatment.&#xD;
&#xD;
          -  No previous history or presence of any disease involving cornea or conjunctiva.&#xD;
&#xD;
          -  Sjӧgren syndrome.&#xD;
&#xD;
          -  History or active cicatricial conjunctivitis.&#xD;
&#xD;
          -  History of ocular surface burns.&#xD;
&#xD;
          -  Use of contact lenses.&#xD;
&#xD;
          -  Corneal refractive surgery 1 year post-operative.&#xD;
&#xD;
          -  Any ocular surgery in the previous 3 months preceding the study.&#xD;
&#xD;
          -  Unstable glaucoma (treatment changes in the last year).&#xD;
&#xD;
          -  Any macular or retinal disease that could impact visual acuity.&#xD;
&#xD;
          -  Best corrected visual acuity (BCVA) below 20/40.&#xD;
&#xD;
          -  Blepharitis treatment started less than 3 months before enrolment.&#xD;
&#xD;
          -  Neurological, neurodegenerative or cerebrovascular conditions.&#xD;
&#xD;
          -  Any clinically significant history of serious digestive tract, liver, kidney,&#xD;
             cardiovascular, cancer or hematological disease.&#xD;
&#xD;
          -  Unstable treatment with systemic medications, such as diuretics, antihistamines,&#xD;
             antidepressants, psychotropics, cholesterol lowering agents and beta-blockers.&#xD;
&#xD;
          -  Known hypersensitivity to one of the administered products.&#xD;
&#xD;
          -  Known drug and/or alcohol abuse.&#xD;
&#xD;
          -  Mental incapacity that precludes adequate understanding or cooperation.&#xD;
&#xD;
          -  Participation in another investigational study or blood donation within 1 month prior&#xD;
             to ICF signature.&#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>Hôpital Morvan</name>
      <address>
        <city>Brest</city>
        <state>Finistère</state>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST-Santi Paolo e Carlo-Presidio San Paolo</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos de Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</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>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04485533
org study id: VF-OS-004/2019
nct id: NCT04485533
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a post-market, european multicenter study. This is a randomized, cross-over, double
      blind study with competitive enrolment, aimed to enroll a total of 90 patients with a
      diagnosis of moderate dry eye disease (DED).
The purpose of the study is to evaluate the non-inferiority of the new treatment versus the
      comparator.

      Patients, after signing the Informed Consent, will enter into a 1-week screening phase during
      which the baseline tests will be conducted.

      Baseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment.

      Between V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic
      evaluations listed in the Flow-Chart will be performed on both eyes of the patient.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Tear Break-Up Time (TBUT)
time frame: through study completion, an average of 2.5 months
description: To evaluate the effect of treatment with VisuXL® GEL versus HYLO® on the stability of the tear film by Tear Break-Up Time (TBUT) in patients affected by moderate dry eye disease (DED).
measure: Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Stability of the tear film
measure: Functional Visual Acuity (FVA)
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Functional Visual Acuity (FVA)
measure: Tear secretion
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Tear secretion
measure: Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Burning, foreign body sensation, itching, and photophobia symptoms of DED.
(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: Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation
measure: Corneal inflammation assessed by staining grade with SICCA Scale
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation
measure: Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
measure: Each of the three modules that are part of IDEEL questionnaire
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Each of the three modules that are part of IDEEL questionnaire
measure: Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way
time frame: through study completion, an average of 2.5 months
description: To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Medical devices' safety and tolerability:
Allergy to any device compound
Any other adverse event (AE)
Adverse device effects (ADEs) -Undetected/unforeseen manufacturing ADE which might bring to application procedure errors -
Contamination of the device nozzle and possibility to contaminate both eyes
Interaction with any other permitted local administered therapy
Vital signs: blood pressure (BP), heart rate (HR), respiratory rate (RR)
arm group label: VisuXL® Gel/HYLO®
arm group type: Experimental
description: Patients treated with VisuXL® ophthalmic gel for the first 30 days (1 treatment period) and with HYLO® for the second 30 days (2 treatment period).
arm group label: HYLO®/VisuXL® Gel
arm group type: Active Comparator
description: Patients treated with HYLO® for the first 30 days (1 treatment period) and with VisuXL® ophthalmic gel for the second 30 days (2 treatment period).
intervention type: Device
intervention name: VisuXL® Gel
description: VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose.
Dose/dosage: 1 drop per eye twice a day.
arm group label: HYLO®/VisuXL® Gel
arm group label: VisuXL® Gel/HYLO®
intervention type: Device
intervention name: HYLO®
description: HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water.
Dose/dosage: 1 drop per eye twice a day
arm group label: HYLO®/VisuXL® Gel
arm group label: VisuXL® Gel/HYLO®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
country: Italy
country: Spain
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: No