<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/NCT03009799</url>
  </required_header>
  <id_info>
    <org_study_id>NCX-4240-15001</org_study_id>
    <nct_id>NCT03009799</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)</brief_title>
  <acronym>Goldeneye</acronym>
  <official_title>Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NicOx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iris Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Theradis pharma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NicOx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in&#xD;
      decreasing the number of days where adenoviral conjunctivis is detected in the eye and in&#xD;
      reducing the duration and/or the severity of the signs and symptoms of adenoviral&#xD;
      conjunctivis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing&#xD;
      carrageenan eye drops (NCX 4240) versus placebo up to 21 days.&#xD;
&#xD;
      Total expected number of patients: 148&#xD;
&#xD;
      Randomization: patients will be randomized 1:1 between:&#xD;
&#xD;
        -  Group A: eye drops containing iota-carrageenan (NCX 4240), 1 drop in each eye 8&#xD;
           times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days&#xD;
           until Day 21 or&#xD;
&#xD;
        -  Group B: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye&#xD;
           8 times/day for 7 days (Mandatory), then 4 to 8 times/day for the next 14 days until Day&#xD;
           21.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study stopped following management decision&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral eradication time NCX 4240 versus Placebo</measure>
    <time_frame>21 days</time_frame>
    <description>Comparison in time to viral eradication in NCX-4240 and the placebo groups (when virus load is 0 or BLD - below the limit of detection) from the tears as measured by Polymerase Chain Reaction (PCR) at each visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative PCR</measure>
    <time_frame>21 days</time_frame>
    <description>1) Quantitative PCR (qPCR) results at all clinical investigation timepoints 4) Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary 5) Ocular signs as assessed by the investigators at each visit and for both eyes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on daily activities</measure>
    <time_frame>21 days</time_frame>
    <description>Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe) 5) Ocular signs as assessed by the investigators at each visit and for both eyes:&#xD;
Degree of bulbar conjunctival injection/hyperaemia will be graded using the Mc Monnies grading scale for conjunctival hyperaemia&#xD;
Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis. Presence/absence of loco-regional lymphadenopathies will also be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient discomfort</measure>
    <time_frame>21 days</time_frame>
    <description>Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bulbar conjuntival infection</measure>
    <time_frame>21 days</time_frame>
    <description>Ocular signs as assessed by the investigators at each visit and for both eyes: degree of bulbar conjunctival infection/hyperaemia will be graded using the McMonnies grading scale for conjunctival hypereaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other signs to be assessed</measure>
    <time_frame>21 days</time_frame>
    <description>Ocular signs as assessed by the investigators at each visit and for both eyes:&#xD;
- Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>loco-regional lymphadenopathies</measure>
    <time_frame>21 days</time_frame>
    <description>Ocular signs as assessed by the investigators at each visit and for both eyes:&#xD;
Presence/absence of loco-regional lymphadenopathies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular symptoms assessed by patients</measure>
    <time_frame>21 days</time_frame>
    <description>Ocular symptoms as assessed by the patients in the patient diary: self-rated daily for 21 days: symptoms sum-score of pain, foreign body sensation, itchy eye(s), photophobia/light sensitivity, ocular secretions and eyelash matting. Assessments will be performed with Likert 5 points scales (none - traces - mild - moderate - severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease impact on daily activities</measure>
    <time_frame>21 days</time_frame>
    <description>Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global patient discomfort</measure>
    <time_frame>21 days</time_frame>
    <description>Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenoplus test results</measure>
    <time_frame>21 days</time_frame>
    <description>AdenoPlus® test results, testing the studied eye at each post baseline visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of Membranes and pseudomembranes development</measure>
    <time_frame>21 days</time_frame>
    <description>For both eyes: Development of membranes, pseudomembranes assessed by the investigator, incidence and severity (none - mild - moderate - severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of Membranes and pseudomembranes development</measure>
    <time_frame>21 days</time_frame>
    <description>For both eyes: timing of occurrence if any</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of Subepithelial Corneal Infiltrates development</measure>
    <time_frame>21 days</time_frame>
    <description>For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of Subepithelial Corneal Infiltrates development</measure>
    <time_frame>21 days</time_frame>
    <description>For both eyes: Development of subepithelial corneal infiltrates: timing of occurrence as assessed by the investigator examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Incidence and severity of fellow eye signs and symptoms</measure>
    <time_frame>21 days</time_frame>
    <description>If only one eye is affected (signs and symptoms) at baseline, assessment of the incidence and severity of the other eye signs and symptoms by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BCVA</measure>
    <time_frame>21 days</time_frame>
    <description>Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of patient's satisfaction</measure>
    <time_frame>21 days</time_frame>
    <description>Global assessment of the patient's satisfaction with the eye drops use with a 4 points Likert scale: poor, fair, good, excellent, will be performed at Day 7, 14 and 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>21 days</time_frame>
    <description>Safety parameters (Adverse Events/Serious Adverse Events)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Adenoviral Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Eye drops containing Iota-Carrageenan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eye drops 3.2mg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ocular Lubricant Eye Drops</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Carmellose 0.5% sterile solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iota-Carrageenan</intervention_name>
    <description>One drop in each eye 8 times per day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until Day 21</description>
    <arm_group_label>Eye drops containing Iota-Carrageenan</arm_group_label>
    <other_name>NCX-4240</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carmellose</intervention_name>
    <description>1 drop in each eye 8 times/day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until day 21</description>
    <arm_group_label>Ocular Lubricant Eye Drops</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus&#xD;
             test&#xD;
&#xD;
          -  Conjunctivis signs and symptoms in at least one eye AND positive adenoplus test in at&#xD;
             least one eye whatever signs/symptoms and positive adenoplus test are from the same&#xD;
             eye or not&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative results with adenoplus test in both eyes&#xD;
&#xD;
          -  a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based&#xD;
             on clinical investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigitte Duquesroix</last_name>
    <role>Study Director</role>
    <affiliation>NicOx</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adenoviral conjunctivis</keyword>
  <keyword>iota-carrageenan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboxymethylcellulose Sodium</mesh_term>
  </intervention_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/NCT03009799
org study id: NCX-4240-15001
nct id: NCT03009799
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in
      decreasing the number of days where adenoviral conjunctivis is detected in the eye and in
      reducing the duration and/or the severity of the signs and symptoms of adenoviral
      conjunctivis
A multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing
      carrageenan eye drops (NCX 4240) versus placebo up to 21 days.

      Total expected number of patients: 148

      Randomization: patients will be randomized 1:1 between:

        -  Group A: eye drops containing iota-carrageenan (NCX 4240), 1 drop in each eye 8
           times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days
           until Day 21 or

        -  Group B: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye
           8 times/day for 7 days (Mandatory), then 4 to 8 times/day for the next 14 days until Day
           21.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Viral eradication time NCX 4240 versus Placebo
time frame: 21 days
description: Comparison in time to viral eradication in NCX-4240 and the placebo groups (when virus load is 0 or BLD - below the limit of detection) from the tears as measured by Polymerase Chain Reaction (PCR) at each visit.
measure: Quantitative PCR
time frame: 21 days
description: 1) Quantitative PCR (qPCR) results at all clinical investigation timepoints 4) Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary 5) Ocular signs as assessed by the investigators at each visit and for both eyes
measure: Impact on daily activities
time frame: 21 days
description: Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe) 5) Ocular signs as assessed by the investigators at each visit and for both eyes:
Degree of bulbar conjunctival injection/hyperaemia will be graded using the Mc Monnies grading scale for conjunctival hyperaemia
Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis. Presence/absence of loco-regional lymphadenopathies will also be recorded
measure: Patient discomfort
time frame: 21 days
description: Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary
measure: bulbar conjuntival infection
time frame: 21 days
description: Ocular signs as assessed by the investigators at each visit and for both eyes: degree of bulbar conjunctival infection/hyperaemia will be graded using the McMonnies grading scale for conjunctival hypereaemia.
measure: Other signs to be assessed
time frame: 21 days
description: Ocular signs as assessed by the investigators at each visit and for both eyes:
- Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis.
measure: loco-regional lymphadenopathies
time frame: 21 days
description: Ocular signs as assessed by the investigators at each visit and for both eyes:
Presence/absence of loco-regional lymphadenopathies
measure: Ocular symptoms assessed by patients
time frame: 21 days
description: Ocular symptoms as assessed by the patients in the patient diary: self-rated daily for 21 days: symptoms sum-score of pain, foreign body sensation, itchy eye(s), photophobia/light sensitivity, ocular secretions and eyelash matting. Assessments will be performed with Likert 5 points scales (none - traces - mild - moderate - severe).
measure: Disease impact on daily activities
time frame: 21 days
description: Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe)
measure: Global patient discomfort
time frame: 21 days
description: Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary
measure: Adenoplus test results
time frame: 21 days
description: AdenoPlus® test results, testing the studied eye at each post baseline visits.
measure: Investigator's assessment of Membranes and pseudomembranes development
time frame: 21 days
description: For both eyes: Development of membranes, pseudomembranes assessed by the investigator, incidence and severity (none - mild - moderate - severe)
measure: Investigator's assessment of Membranes and pseudomembranes development
time frame: 21 days
description: For both eyes: timing of occurrence if any
measure: Investigator's assessment of Subepithelial Corneal Infiltrates development
time frame: 21 days
description: For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator
measure: Investigator's assessment of Subepithelial Corneal Infiltrates development
time frame: 21 days
description: For both eyes: Development of subepithelial corneal infiltrates: timing of occurrence as assessed by the investigator examination
measure: Assessment of Incidence and severity of fellow eye signs and symptoms
time frame: 21 days
description: If only one eye is affected (signs and symptoms) at baseline, assessment of the incidence and severity of the other eye signs and symptoms by the investigator
measure: BCVA
time frame: 21 days
description: Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).
measure: Global assessment of patient's satisfaction
time frame: 21 days
description: Global assessment of the patient's satisfaction with the eye drops use with a 4 points Likert scale: poor, fair, good, excellent, will be performed at Day 7, 14 and 21
measure: Adverse events
time frame: 21 days
description: Safety parameters (Adverse Events/Serious Adverse Events)
arm group label: Eye drops containing Iota-Carrageenan
arm group type: Active Comparator
description: Eye drops 3.2mg/ml
arm group label: Ocular Lubricant Eye Drops
arm group type: Placebo Comparator
description: Carmellose 0.5% sterile solution
intervention type: Drug
intervention name: Iota-Carrageenan
description: One drop in each eye 8 times per day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until Day 21
arm group label: Eye drops containing Iota-Carrageenan
other name: NCX-4240
intervention type: Drug
intervention name: Carmellose
description: 1 drop in each eye 8 times/day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until day 21
arm group label: Ocular Lubricant Eye Drops
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brigitte Duquesroix
role: Study Director
affiliation: NicOx
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Carboxymethylcellulose Sodium
sharing ipd: Undecided