<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/NCT03822559</url>
  </required_header>
  <id_info>
    <org_study_id>0111A04LT</org_study_id>
    <nct_id>NCT03822559</nct_id>
  </id_info>
  <brief_title>A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension</brief_title>
  <official_title>A Randomized, Double-masked, Controlled Parallel Group, Multi-center Study of DE-111A (Fixed Dose Combination of Tafluprost and Timolol Eye Drops) on the Treatment of Open Angle Glaucoma or Ocular Hypertension (With Tafluprost Eye Drops as a Comparator)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santen Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Santen Pharmaceutical Co., Ltd.</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 objective of this study is to investigate whether the IOP (intraocular pressure)&#xD;
      -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost&#xD;
      and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is&#xD;
      superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time,&#xD;
      once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China&#xD;
      as well as comparison of safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">April 4, 2023</completion_date>
  <primary_completion_date type="Actual">April 4, 2023</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the average diurnal IOP (intraocular pressure)</measure>
    <time_frame>Three months</time_frame>
    <description>Diurnal IOP measurements will be performed at 8:00 (±1 h), 10:00 (±1 h) and 16:00 (±1 h).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Open-angle Glaucoma, Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>DE-111A eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>0.0015% tafluprost eye drops</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL</intervention_name>
    <description>One drop a time, once daily administration of DE-111A eye drops in the affected eye(s) at 8:00 am (±1h) for 3 months.</description>
    <arm_group_label>DE-111A eye drops</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL</intervention_name>
    <description>One drop a time, once daily administration of preservative-free 0.0015% tafluprost eye drops in the affected eye(s) at 8:00 (±1h) for 3 months.</description>
    <arm_group_label>0.0015% tafluprost eye drops</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of open angle glaucoma (including primary open angle glaucoma, exfoliation&#xD;
             glaucoma or pigmentary glaucoma) in one or both eyes or ocular hypertension for which&#xD;
             the subject has been using prostaglandin or beta-adrenergic blocker IOP (intraocular&#xD;
             pressure) -lowering drugs before the screening visit&#xD;
&#xD;
          -  Those who have signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, nursing or planning pregnancy, or women of child-bearing&#xD;
             potential who are not using a reliable method of contraception&#xD;
&#xD;
          -  Anterior chamber angle in either eye to be treated with the level &lt;2 according to&#xD;
             Shaffer classification as measured by gonioscopy&#xD;
&#xD;
          -  Corneal disorder or other disease preventing reliable applanation tonometry in the&#xD;
             treated eyes, including refractive surgery of ocular anterior segment)&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Current participation in another clinical trial involving an investigational&#xD;
             drug/device, or participation in such a trial within 30 days before Screening visit&#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>Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye &amp; Ent Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</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>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Timolol</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <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/NCT03822559
org study id: 0111A04LT
nct id: NCT03822559
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate whether the IOP (intraocular pressure)
      -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost
      and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is
      superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time,
      once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China
      as well as comparison of safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline in the average diurnal IOP (intraocular pressure)
time frame: Three months
description: Diurnal IOP measurements will be performed at 8:00 (±1 h), 10:00 (±1 h) and 16:00 (±1 h).
arm group label: DE-111A eye drops
arm group type: Experimental
arm group label: 0.0015% tafluprost eye drops
arm group type: Active Comparator
intervention type: Drug
intervention name: A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL
description: One drop a time, once daily administration of DE-111A eye drops in the affected eye(s) at 8:00 am (±1h) for 3 months.
arm group label: DE-111A eye drops
intervention type: Drug
intervention name: A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL
description: One drop a time, once daily administration of preservative-free 0.0015% tafluprost eye drops in the affected eye(s) at 8:00 (±1h) for 3 months.
arm group label: 0.0015% tafluprost eye drops
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Timolol
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
sharing ipd: No