<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/NCT04422743</url>
  </required_header>
  <id_info>
    <org_study_id>NP2017</org_study_id>
    <nct_id>NCT04422743</nct_id>
  </id_info>
  <brief_title>Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma</brief_title>
  <official_title>Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Matteo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Matteo</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 general purpose of the study is to evaluate the potential beneficial effects of&#xD;
      supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal&#xD;
      ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of&#xD;
      Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    due to covid 19 pandemy&#xD;
  </why_stopped>
  <start_date type="Actual">January 25, 2018</start_date>
  <completion_date type="Actual">September 11, 2020</completion_date>
  <primary_completion_date type="Actual">September 11, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy</measure>
    <time_frame>4 months of therapy 2 months of wash out 4 months without adding therapy</time_frame>
    <description>changes in amplitude (microVolt)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity</measure>
    <time_frame>4 months of therapy 2 months of wash out 4 months without adding therapy</time_frame>
    <description>changes in visual acuity (decimals)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field</measure>
    <time_frame>4 months of therapy 2 months of wash out 4 months without adding therapy</time_frame>
    <description>changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life</measure>
    <time_frame>4 months of therapy 2 months of wash out 4 months without adding therapy</time_frame>
    <description>changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>standard of care + citicoline plus homotaurine (CIT/HOMO)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Citicoline 500 mg plus Homotaurine 50 mg</intervention_name>
    <description>Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy</description>
    <arm_group_label>standard of care + citicoline plus homotaurine (CIT/HOMO)</arm_group_label>
    <other_name>CIT/HOMO</other_name>
    <other_name>Neuprozin®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 40 and 75 years;&#xD;
&#xD;
          -  diagnosis of primary OAG (POAG) from, at least, 3 years;&#xD;
&#xD;
          -  visual acuity &gt; 0.7 (7/10) decimals;&#xD;
&#xD;
          -  refractive error &lt; 5 D (spheric) and &lt; 2D (toric);&#xD;
&#xD;
          -  transparent diopter means (cornea and lens);&#xD;
&#xD;
          -  controlled IOP (&lt;18 mmHg, morning value) with beta-blockers and prostaglandin&#xD;
             analogues as monotherapy or as associative therapy (fixed or unfixed);&#xD;
&#xD;
          -  stable IOP&lt;18 mmHg in the last 2 years;&#xD;
&#xD;
          -  stable and unchanged topical therapy in the last 6 months;&#xD;
&#xD;
          -  stable disease in the last 2 years (no more than -1 dB/year at MD of visual field);&#xD;
&#xD;
          -  at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold&#xD;
             algorithm -SITA- Standard) per year in the last 2 years;&#xD;
&#xD;
          -  early to moderate visual field defect (MD &lt;12 dB);&#xD;
&#xD;
          -  electrophysiological (PERG) parameters alterations similar to glaucomatous pathology;&#xD;
&#xD;
          -  written consent to participate to study procedures and data utilization in an&#xD;
             anonymous form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;&#xD;
&#xD;
          -  congenital glaucoma; secondary glaucoma; normal tension glaucoma;&#xD;
&#xD;
          -  history of recurrent uveitis/scleritis/herpes infection;&#xD;
&#xD;
          -  pregnancy and breastfeeding;&#xD;
&#xD;
          -  contraindication to Citicoline and/or Homotaurine&#xD;
&#xD;
          -  contraindication to beta-blockers and prostaglandine analogues&#xD;
&#xD;
          -  topical therapy with Brimonidine monotherapy or fixed combination (with timolol or&#xD;
             brinzolamide)&#xD;
&#xD;
          -  topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination&#xD;
             systemic or topical treatment with another neuroprotective agent in the last 4 months&#xD;
             prior to enrollment&#xD;
&#xD;
          -  systemic therapies affecting patients' performance in visual field examination&#xD;
             (sedatives);&#xD;
&#xD;
          -  glaucomatous scotomas within 10 degree from fixation&#xD;
&#xD;
          -  any condition limiting the patient's ability to participate in the study;&#xD;
&#xD;
          -  other ocular causes of visual field and PERG changes, such as cataract, myopic&#xD;
             chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy;&#xD;
&#xD;
          -  other systemic causes of visual field and PERG changes such as neurodegenerative&#xD;
             disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders;&#xD;
&#xD;
          -  cerebral ischemia in the last 2 years&#xD;
&#xD;
          -  any change in topical therapy in the 6 months prior to enrollment or during the study&#xD;
             period concomitant participation to another clinical trial&#xD;
&#xD;
          -  any previous filtering and/or retinal surgery;&#xD;
&#xD;
          -  cataract surgery in the last 6 months;&#xD;
&#xD;
          -  any previous laser treatment for glaucoma in the last 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gemma caterina m Rossi</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Fondazione Policlinico San Matteo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gemma Caterina Maria Rossi</name>
      <address>
        <city>Pavia</city>
        <state>PV</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dario Sisto</name>
      <address>
        <city>Bari</city>
        <zip>70121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberto Mavilio</name>
      <address>
        <city>Brindisi</city>
        <zip>72100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teresa Rolle</name>
      <address>
        <city>Torino</city>
        <zip>10121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 11, 2021</last_update_submitted>
  <last_update_submitted_qc>November 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Matteo</investigator_affiliation>
    <investigator_full_name>Rossi, Gemma Caterina Maria</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pattern electroretinogram</keyword>
  <keyword>visual field</keyword>
  <keyword>quality of life</keyword>
  <keyword>citicoline 500 mg plus homotaurine 50 mg</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramiprosate</mesh_term>
    <mesh_term>Cytidine Diphosphate Choline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>data will be published on peer review journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>upon publication</ipd_time_frame>
    <ipd_access_criteria>actually not available</ipd_access_criteria>
  </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/NCT04422743
org study id: NP2017
nct id: NCT04422743
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the general purpose of the study is to evaluate the potential beneficial effects of
      supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal
      ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.
Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of
      Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
description: changes in amplitude (microVolt)
measure: To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
description: changes in visual acuity (decimals)
measure: to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
description: changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters
measure: to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
description: changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)
arm group label: standard of care + citicoline plus homotaurine (CIT/HOMO)
arm group type: Experimental
description: CIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication)
arm group label: standard of care
arm group type: No Intervention
description: only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months
intervention type: Dietary Supplement
intervention name: Citicoline 500 mg plus Homotaurine 50 mg
description: Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy
arm group label: standard of care + citicoline plus homotaurine (CIT/HOMO)
other name: CIT/HOMO
other name: Neuprozin®
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: gemma caterina m Rossi
role: Study Director
affiliation: IRCCS Fondazione Policlinico San Matteo
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Matteo
investigator full name: Rossi, Gemma Caterina Maria
investigator title: Principal Investigator
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Tramiprosate
mesh term: Cytidine Diphosphate Choline
sharing ipd: Yes
ipd description: data will be published on peer review journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: upon publication
ipd access criteria: actually not available