<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/NCT02199327</url>
  </required_header>
  <id_info>
    <org_study_id>R-2012-785-094</org_study_id>
    <nct_id>NCT02199327</nct_id>
  </id_info>
  <brief_title>Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia</brief_title>
  <official_title>Clinical Trial to Compare Topical Interferon Alfa 2b And Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Guadalajara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and&#xD;
      topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial&#xD;
      neoplasia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of&#xD;
      the ocular surface. Classic treatment is complete excision with safety margins, however,&#xD;
      usually the edges are not sharp and difficult clinical differentiation between healthy areas&#xD;
      that are not; to this treatment has joined him carrying out cryotherapy bedding and borders .&#xD;
      Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been&#xD;
      used either as adjuvant or primary treatment . Among the drugs used the investigators have&#xD;
      mitomycin C (MMC) and interferon alpha 2b (INFα 2b).&#xD;
&#xD;
      Controlled clinical trial , single-blind , randomized . Non-probability sampling of&#xD;
      consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic&#xD;
      clinical evaluations and photos will be made. Time of resolution, resistance and adverse&#xD;
      effects will be determined.&#xD;
&#xD;
      Patients treated with mitomycin will be handled by cycles until resolution of the lesion,&#xD;
      which according to previous studies is expected between 3 and 6 cycles (between half months&#xD;
      and 3 months).&#xD;
&#xD;
      Patients managed with interferon will be treated for a period ranging from one month to 12&#xD;
      months according to clinical resolution of the lesion. Both groups will be evaluated by at&#xD;
      least one year after the resolution of the lesion to determine the presence of recurrences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">December 16, 2016</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia</measure>
    <time_frame>One month to one year</time_frame>
    <description>Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).&#xD;
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse effects with topic therapy</measure>
    <time_frame>One to two years</time_frame>
    <description>Watch as topical treatment is maintained and at least one years after the resolution of the lesion.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Recurrence of conjunctival-corneal intraepithelial neoplasia</measure>
    <time_frame>One year</time_frame>
    <description>Watch at least one year after the resolution of the lesion to detect recurrence.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Conjunctival Intraepithelial Neoplasia</condition>
  <condition>Corneal Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>Mitomycin C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interferon alfa 2b</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitomycin C</intervention_name>
    <description>Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).</description>
    <arm_group_label>Mitomycin C</arm_group_label>
    <other_name>Mutamycin</other_name>
    <other_name>Mitomycin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interferon Alfa-2b</intervention_name>
    <description>Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences</description>
    <arm_group_label>Interferon alfa 2b</arm_group_label>
    <other_name>Urifron</other_name>
    <other_name>Intron A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical diagnosis of corneal and conjunctival intraepithelial neoplasia&#xD;
             (CIN) with no history of ocular neoplasia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who did not agree to participate in the study.&#xD;
&#xD;
          -  Patients with corneal abrasion&#xD;
&#xD;
          -  Patients who have the diagnosis of CIN, but are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alvarado Beatriz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Mexicano del Seguro Social</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IMSS Centro Médico de Occidente</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Conjunctival-corneal intraepithelial neoplasia</keyword>
  <keyword>Mitomycin C</keyword>
  <keyword>Interferon alfa 2b</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
    <mesh_term>Interferon alpha-2</mesh_term>
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>we intend to publish the results as a scientific article with all results of participants</ipd_description>
  </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/NCT02199327
org study id: R-2012-785-094
nct id: NCT02199327
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and
      topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial
      neoplasia.
The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of
      the ocular surface. Classic treatment is complete excision with safety margins, however,
      usually the edges are not sharp and difficult clinical differentiation between healthy areas
      that are not; to this treatment has joined him carrying out cryotherapy bedding and borders .
      Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been
      used either as adjuvant or primary treatment . Among the drugs used the investigators have
      mitomycin C (MMC) and interferon alpha 2b (INFα 2b).

      Controlled clinical trial , single-blind , randomized . Non-probability sampling of
      consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic
      clinical evaluations and photos will be made. Time of resolution, resistance and adverse
      effects will be determined.

      Patients treated with mitomycin will be handled by cycles until resolution of the lesion,
      which according to previous studies is expected between 3 and 6 cycles (between half months
      and 3 months).

      Patients managed with interferon will be treated for a period ranging from one month to 12
      months according to clinical resolution of the lesion. Both groups will be evaluated by at
      least one year after the resolution of the lesion to determine the presence of recurrences.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia
time frame: One month to one year
description: Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.
measure: Adverse effects with topic therapy
time frame: One to two years
description: Watch as topical treatment is maintained and at least one years after the resolution of the lesion.
measure: Recurrence of conjunctival-corneal intraepithelial neoplasia
time frame: One year
description: Watch at least one year after the resolution of the lesion to detect recurrence.
arm group label: Mitomycin C
arm group type: Active Comparator
description: Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).
arm group label: Interferon alfa 2b
arm group type: Active Comparator
description: Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor
intervention type: Drug
intervention name: Mitomycin C
description: Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
arm group label: Mitomycin C
other name: Mutamycin
other name: Mitomycin
intervention type: Drug
intervention name: Interferon Alfa-2b
description: Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences
arm group label: Interferon alfa 2b
other name: Urifron
other name: Intron A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Alvarado Beatriz, M.D.
role: Principal Investigator
affiliation: Instituto Mexicano del Seguro Social
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Interferons
mesh term: Interferon-alpha
mesh term: Interferon alpha-2
mesh term: Mitomycins
mesh term: Mitomycin
sharing ipd: No
ipd description: we intend to publish the results as a scientific article with all results of participants