<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/NCT01714960</url>
  </required_header>
  <id_info>
    <org_study_id>MRZ99030_1001_1</org_study_id>
    <secondary_id>2012-002664-26</secondary_id>
    <nct_id>NCT01714960</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients</brief_title>
  <official_title>Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merz Pharmaceuticals GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merz Pharmaceuticals GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To assess the safety and tolerability of repeat dose topical administration of MRZ-99030&#xD;
           Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma&#xD;
           subjects (stage 2).&#xD;
&#xD;
        -  To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its&#xD;
           metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030&#xD;
           Ophthalmic Solution.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Day 1 up to day 23</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>Day 1 to day 17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal plasma concentration (Cmax)</measure>
    <time_frame>Day 1 to day 17</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Healthy Volunteers and Glaucoma Patients</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo eye drops, 1-3 drops three times per day, duration: 16 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MRZ-99030 eye drops 5mg/mL</intervention_name>
    <arm_group_label>Healthy volunteers low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MRZ-99030 eye drops 20mg/mL</intervention_name>
    <arm_group_label>Glaucoma patients</arm_group_label>
    <arm_group_label>Healthy volunteers high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to MRZ-99030 eye drops</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For stage 1:&#xD;
&#xD;
        - Healthy volunteers&#xD;
&#xD;
        For stage 2:&#xD;
&#xD;
        - Glaucoma patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For stage 2:&#xD;
&#xD;
        - Any relevant eye disease other than glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Expert</last_name>
    <role>Study Director</role>
    <affiliation>Merz Pharmaceuticals GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel International GmbH, Early Phase Clinical Unit</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>January 28, 2014</last_update_submitted>
  <last_update_submitted_qc>January 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <!-- 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/NCT01714960
org study id: MRZ99030_1001_1
secondary id: 2012-002664-26
nct id: NCT01714960
lead sponsor: 
has dmc: No
-  To assess the safety and tolerability of repeat dose topical administration of MRZ-99030
           Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma
           subjects (stage 2).

        -  To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its
           metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030
           Ophthalmic Solution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of adverse events
time frame: Day 1 up to day 23
measure: Area under the curve (AUC)
time frame: Day 1 to day 17
measure: Maximal plasma concentration (Cmax)
time frame: Day 1 to day 17
arm group label: Healthy volunteers low dose
arm group type: Experimental
description: MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.
arm group label: Healthy volunteers high dose
arm group type: Experimental
description: MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
arm group label: Glaucoma patients
arm group type: Experimental
description: MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo eye drops, 1-3 drops three times per day, duration: 16 days.
intervention type: Drug
intervention name: MRZ-99030 eye drops 5mg/mL
arm group label: Healthy volunteers low dose
intervention type: Drug
intervention name: MRZ-99030 eye drops 20mg/mL
arm group label: Glaucoma patients
arm group label: Healthy volunteers high dose
intervention type: Drug
intervention name: Placebo to MRZ-99030 eye drops
arm group label: Placebo
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Expert
role: Study Director
affiliation: Merz Pharmaceuticals GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ophthalmic Solutions