<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/NCT01733992</url>
  </required_header>
  <id_info>
    <org_study_id>C-932348-002</org_study_id>
    <nct_id>NCT01733992</nct_id>
  </id_info>
  <brief_title>A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease</brief_title>
  <official_title>A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigel Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigel Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of&#xD;
      R348 eye drops in patients with dry eye disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled single and multiple ascending dose&#xD;
      study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered&#xD;
      in patients with mild to moderate keratoconjunctivitis sicca (KCS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in corneal fluorescein staining</measure>
    <time_frame>Baseline and Visits 4, 8 and 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in conjunctival lissamine green staining</measure>
    <time_frame>Baseline and Visits 4, 8 and 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Schirmer test</measure>
    <time_frame>Baseline and Visits 4, 8 and 12</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Keratoconjunctivitis Sicca</condition>
  <arm_group>
    <arm_group_label>R348 Ophthalmic Solution, 0.2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R348 Ophthalmic Solution, 0.5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R348 Ophthalmic Solution, 1.0%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R348 Ophthalmic Solution, 0.2%</intervention_name>
    <description>R348 Ophthalmic Solution, 0.2% single and multiple ascending dose</description>
    <arm_group_label>R348 Ophthalmic Solution, 0.2%</arm_group_label>
    <other_name>R932348</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R348 Ophthalmic Solution, 0.5%</intervention_name>
    <description>R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose</description>
    <arm_group_label>R348 Ophthalmic Solution, 0.5%</arm_group_label>
    <other_name>R932348</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R348 Ophthalmic Solution, 1.0%</intervention_name>
    <description>R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose</description>
    <arm_group_label>R348 Ophthalmic Solution, 1.0%</arm_group_label>
    <other_name>R932348</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, single and multiple ascending dose</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>R348 Ophthalmic Solution, 0.2%</arm_group_label>
    <arm_group_label>R348 Ophthalmic Solution, 0.5%</arm_group_label>
    <arm_group_label>R348 Ophthalmic Solution, 1.0%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to moderate Keratoconjunctivitis Sicca.&#xD;
&#xD;
          -  A corrected visual acuity in both eyes of 20/40 or better.&#xD;
&#xD;
          -  An intraocular pressure of &lt; 21 mm Hg with a difference between eyes of &lt; 6 mm Hg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or evidence of ocular infection, inflammation, or conjunctivitis within 2&#xD;
             months prior to the first dosing day.&#xD;
&#xD;
          -  History or evidence of blepharitis requiring the use of antibiotics or eye scrubs&#xD;
             within 2 months prior to the first dosing day.&#xD;
&#xD;
          -  History of herpes simplex keratitis at any time.&#xD;
&#xD;
          -  Current ocular allergy symptoms.&#xD;
&#xD;
          -  Recent use of eye medications such as steroids or cyclosporine&#xD;
&#xD;
          -  Refractive eye surgery within 12 months of the first dosing day.&#xD;
&#xD;
          -  Other eye surgeries within 4 months of the first dosing day.&#xD;
&#xD;
          -  Current use of contact lenses or discontinuation of contact lens use within 2 weeks of&#xD;
             the first dosing day.&#xD;
&#xD;
          -  Receipt of any blood or blood products within 90 days prior to the first dosing day.&#xD;
&#xD;
          -  Participation in any clinical study within 30 days prior to the first dosing day.&#xD;
&#xD;
          -  History of disease, or currently have a significant illness or abnormal laboratory&#xD;
             finding as determined by your study doctor.&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C or HIV.&#xD;
&#xD;
          -  Smoked regularly within 12 months of first dosing day.&#xD;
&#xD;
          -  History of substance abuse, drug addiction or alcoholism.&#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>Gail Torkildsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andover Eye Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 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>Keratoconjunctivitis</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <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/NCT01733992
org study id: C-932348-002
nct id: NCT01733992
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      R348 eye drops in patients with dry eye disease.
This is a randomized, double-blind, placebo-controlled single and multiple ascending dose
      study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered
      in patients with mild to moderate keratoconjunctivitis sicca (KCS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in corneal fluorescein staining
time frame: Baseline and Visits 4, 8 and 12
measure: Change in conjunctival lissamine green staining
time frame: Baseline and Visits 4, 8 and 12
measure: Change in Schirmer test
time frame: Baseline and Visits 4, 8 and 12
arm group label: R348 Ophthalmic Solution, 0.2%
arm group type: Active Comparator
description: R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
arm group label: R348 Ophthalmic Solution, 0.5%
arm group type: Active Comparator
description: R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
arm group label: R348 Ophthalmic Solution, 1.0%
arm group type: Active Comparator
description: R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
intervention type: Drug
intervention name: R348 Ophthalmic Solution, 0.2%
description: R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
arm group label: R348 Ophthalmic Solution, 0.2%
other name: R932348
intervention type: Drug
intervention name: R348 Ophthalmic Solution, 0.5%
description: R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
arm group label: R348 Ophthalmic Solution, 0.5%
other name: R932348
intervention type: Drug
intervention name: R348 Ophthalmic Solution, 1.0%
description: R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
arm group label: R348 Ophthalmic Solution, 1.0%
other name: R932348
intervention type: Drug
intervention name: Placebo
description: Placebo, single and multiple ascending dose
arm group label: Placebo
arm group label: R348 Ophthalmic Solution, 0.2%
arm group label: R348 Ophthalmic Solution, 0.5%
arm group label: R348 Ophthalmic Solution, 1.0%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gail Torkildsen, MD
role: Principal Investigator
affiliation: Andover Eye Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconjunctivitis
mesh term: Keratoconjunctivitis Sicca
mesh term: Dry Eye Syndromes
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions