<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/NCT04455126</url>
  </required_header>
  <id_info>
    <org_study_id>0105556</org_study_id>
    <nct_id>NCT04455126</nct_id>
  </id_info>
  <brief_title>Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma</brief_title>
  <official_title>Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma: A Prospective Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</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>
      Glaucoma encompasses a collective group of optic neuropathies characterized by progressive&#xD;
      degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive&#xD;
      appearance of the optic disc, and a pattern of visual loss&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian&#xD;
      market. It contains the PG analog tafluprost. Better tolerability, higher adherence to&#xD;
      treatment and improvement of patients' quality of life are associated with using&#xD;
      preservative-free eye drops.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraocular pressure (IOP)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Intraocular pressure (IOP)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Preservative-free tafluprost</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preservative-free tafluprost eye drops</intervention_name>
    <description>This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops</description>
    <arm_group_label>Preservative-free tafluprost</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications&#xD;
             and surgery, able to read, comprehend, and complete the Ocular Surface Disease Index&#xD;
             (OSDI) questionnaire, and able to provide informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Doheim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Amir abou Samra</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_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/NCT04455126
org study id: 0105556
nct id: NCT04455126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Glaucoma encompasses a collective group of optic neuropathies characterized by progressive
      degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive
      appearance of the optic disc, and a pattern of visual loss
Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian
      market. It contains the PG analog tafluprost. Better tolerability, higher adherence to
      treatment and improvement of patients' quality of life are associated with using
      preservative-free eye drops.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops.
primary purpose: Treatment
masking: None (Open Label)
measure: Intraocular pressure (IOP)
time frame: 12 weeks
description: Intraocular pressure (IOP)
arm group label: Preservative-free tafluprost
arm group type: Experimental
description: This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops
intervention type: Drug
intervention name: Preservative-free tafluprost eye drops
description: This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops
arm group label: Preservative-free tafluprost
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed Doheim
role: Principal Investigator
affiliation: Alexandria Faculty of Medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Amir abou Samra
investigator title: Prof.
mesh term: Glaucoma
mesh term: Ophthalmic Solutions
sharing ipd: No