<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/NCT01670266</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-9054IOU002</org_study_id>
    <nct_id>NCT01670266</nct_id>
  </id_info>
  <brief_title>Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma</brief_title>
  <official_title>A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharma USA Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and tolerability of 3 planned&#xD;
      doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension&#xD;
      (OHT) or mild open angle-glaucoma (OAG).&#xD;
&#xD;
      The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the&#xD;
      pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its&#xD;
      tolerability following morning and evening dosing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 1</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>Safety and tolerability of ONO-9054</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of PK profiles</measure>
    <time_frame>up to 14 days</time_frame>
    <description>The mean concentrations of ONO-9054 and its active metabolite will be measured in plasma in order to determine peak and trough levels over a dosing period of 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of PD measurements</measure>
    <time_frame>up to 14 days</time_frame>
    <description>The pharmacodynamic measurement will be intraocular pressure. Relative changes with respect to baseline will be assessed after 14 days of administration under both AM and PM dosing conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of safety, tolerability between once daily morning and once daily evening</measure>
    <time_frame>14 days</time_frame>
    <description>Safety and tolerability of a single concentration will be evaluated by review of adverse events and any change from baseline in ocular symptoms in a crossover arm in which the active drug is administered for 14 days under both AM and PM dosing conditions.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Ocular Hypertension (OHT)</condition>
  <condition>Mild Open Angle-glaucoma (OAG)</condition>
  <arm_group>
    <arm_group_label>Experimental Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched placebo eye drops dosed in same manner as ONO-9054</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-9054</intervention_name>
    <arm_group_label>Experimental Arm 1</arm_group_label>
    <arm_group_label>Experimental Arm 2</arm_group_label>
    <arm_group_label>Experimental Arm 3</arm_group_label>
    <arm_group_label>Experimental Arm 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Experimental Arm 4</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG&#xD;
&#xD;
          -  Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma&#xD;
&#xD;
          -  Able to undergo washout of all ocular drugs&#xD;
&#xD;
          -  An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35&#xD;
             mmHg at all time points in both eyes on Day -2 and Day -1&#xD;
&#xD;
          -  Central corneal thickness 500-600 µm at screening in both eyes&#xD;
&#xD;
          -  BCVA 20/100 or better in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of severe ocular trauma in either eye at any time&#xD;
&#xD;
          -  Any history of previous intraocular or ocular laser surgery within the past 3 months&#xD;
             or any refractive surgery procedure within the past 6 months of screening visit in the&#xD;
             study eye(s)&#xD;
&#xD;
          -  Cataracts that prevent observation of the fundus in either eye&#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>Ono Pharma USA, Inc.</last_name>
    <role>Study Director</role>
    <affiliation>Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Costa Mesa Clinical Site</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newport Beach (satellite site)</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Ana (satellite site)</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>May 31, 2013</last_update_submitted>
  <last_update_submitted_qc>May 31, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ONO-9054</keyword>
  <keyword>ocular hypertension</keyword>
  <keyword>OHT</keyword>
  <keyword>Open angle-glaucoma</keyword>
  <keyword>OAG</keyword>
  <keyword>Glaucoma</keyword>
  <keyword>Eye diseases</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>
  <!-- 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/NCT01670266
org study id: ONO-9054IOU002
nct id: NCT01670266
lead sponsor: 
has dmc: No
The primary objective of this study is to evaluate the safety and tolerability of 3 planned
      doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension
      (OHT) or mild open angle-glaucoma (OAG).

      The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the
      pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its
      tolerability following morning and evening dosing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Safety and tolerability of ONO-9054
time frame: up to 14 days
description: Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days
measure: Characterization of PK profiles
time frame: up to 14 days
description: The mean concentrations of ONO-9054 and its active metabolite will be measured in plasma in order to determine peak and trough levels over a dosing period of 14 days
measure: Evaluation of PD measurements
time frame: up to 14 days
description: The pharmacodynamic measurement will be intraocular pressure. Relative changes with respect to baseline will be assessed after 14 days of administration under both AM and PM dosing conditions.
measure: Comparison of safety, tolerability between once daily morning and once daily evening
time frame: 14 days
description: Safety and tolerability of a single concentration will be evaluated by review of adverse events and any change from baseline in ocular symptoms in a crossover arm in which the active drug is administered for 14 days under both AM and PM dosing conditions.
arm group label: Experimental Arm 1
arm group type: Experimental
description: Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18
arm group label: Experimental Arm 2
arm group type: Experimental
description: Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18
arm group label: Experimental Arm 3
arm group type: Experimental
description: Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18
arm group label: Experimental Arm 4
arm group type: Experimental
description: Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Matched placebo eye drops dosed in same manner as ONO-9054
intervention type: Drug
intervention name: ONO-9054
arm group label: Experimental Arm 1
arm group label: Experimental Arm 2
arm group label: Experimental Arm 3
arm group label: Experimental Arm 4
intervention type: Drug
intervention name: Placebo
arm group label: Experimental Arm 4
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ono Pharma USA, Inc.
role: Study Director
affiliation: Ono Pharmaceutical Co. Ltd
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension