<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/NCT02235259</url>
  </required_header>
  <id_info>
    <org_study_id>SDD-1004-059</org_study_id>
    <nct_id>NCT02235259</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of XG-104 for the Treatment of Dry Eye</brief_title>
  <official_title>A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xigen SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xigen SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic&#xD;
      Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4&#xD;
      week Three Times a Day (TID) treatment period&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</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>Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale</measure>
    <time_frame>Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Worst Dry Eye Symptom</measure>
    <time_frame>From D22 to Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Film Break-up Time (Pre- and Post-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Film Break-up Time (Pre- and Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Osmolarity (Post-CAESM)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Osmolarity (Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unanesthetized Schirmer's Test (Pre-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unanesthetized Schirmer's Test (Pre-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop Comfort and Symptom Assessment using Ora Calibra™ Scales</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop Comfort and Symptom Assessment using Ora Calibra™ Scales</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) (Pre-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) (Pre-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)</measure>
    <time_frame>Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily diary</measure>
    <time_frame>up to Day 29</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual Acuity (ETDRS) (Pre-CAESM)</measure>
    <time_frame>Day -7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual Acuity (ETDRS) (Pre-CAESM)</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual Acuity (ETDRS) (Pre-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual Acuity (ETDRS) (Pre-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)</measure>
    <time_frame>Day -7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)</measure>
    <time_frame>Day 15</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)</measure>
    <time_frame>Day 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse event query</measure>
    <time_frame>up to Day 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Dilated Fundoscopy Biomicroscopy</measure>
    <time_frame>Day -7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Dilated Fundoscopy Biomicroscopy</measure>
    <time_frame>Day 29</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intraocular Pressure</measure>
    <time_frame>Day -7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intraocular Pressure</measure>
    <time_frame>Day 29</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>XG-104 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>XG-104 intermediate dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>XG-104 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XG-104</intervention_name>
    <description>Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy</description>
    <arm_group_label>XG-104 high dose</arm_group_label>
    <arm_group_label>XG-104 intermediate dose</arm_group_label>
    <arm_group_label>XG-104 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Have a subject reported history of dry eye&#xD;
&#xD;
          -  Have a history of use or desire to use eye drops&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any clinically significant eye findings that require therapeutic treatment,&#xD;
             and/or in the opinion of the Investigator may interfere with study parameters;&#xD;
&#xD;
          -  Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses&#xD;
             during the study;&#xD;
&#xD;
          -  Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the&#xD;
             last 12 months;&#xD;
&#xD;
          -  Have used Restasis® within 30 days of Visit 1;&#xD;
&#xD;
          -  Have any planned ocular and/or lid surgeries over the study period;&#xD;
&#xD;
          -  Be a woman who is pregnant, nursing or planning a pregnancy;&#xD;
&#xD;
          -  Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early&#xD;
             termination visit) if of childbearing potential.&#xD;
&#xD;
          -  Have a known allergy and/or sensitivity to the study drug or its components&#xD;
&#xD;
          -  Have a condition or be in a situation which the Investigator feels may put the subject&#xD;
             at significant risk, may confound the study results, or may interfere significantly&#xD;
             with the subject's participation in the study;&#xD;
&#xD;
          -  Be currently enrolled in an investigational drug or device study or have used an&#xD;
             investigational drug or device within 30 days of Visit 1;&#xD;
&#xD;
          -  Be unable or unwilling to follow instructions, including participation in all study&#xD;
             assessments and visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <disposition_first_submitted>July 15, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 15, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 18, 2016</disposition_first_posted>
  <last_update_submitted>July 15, 2016</last_update_submitted>
  <last_update_submitted_qc>July 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2016</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>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02235259
org study id: SDD-1004-059
nct id: NCT02235259
lead sponsor: 
has dmc: No
The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic
      Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4
      week Three Times a Day (TID) treatment period
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale
time frame: Day 29
measure: Worst Dry Eye Symptom
time frame: From D22 to Day 28
measure: Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
time frame: Day 15
measure: Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
time frame: Day 29
measure: Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM
time frame: Day 15
measure: Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM
time frame: Day 29
measure: Tear Film Break-up Time (Pre- and Post-CAESM)
time frame: Day 15
measure: Tear Film Break-up Time (Pre- and Post-CAESM)
time frame: Day 29
measure: Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
time frame: Day 15
measure: Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
time frame: Day 29
measure: Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
time frame: Day 15
measure: Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
time frame: Day 29
measure: Tear Osmolarity (Post-CAESM)
time frame: Day 1
measure: Tear Osmolarity (Post-CAESM)
time frame: Day 29
measure: Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
time frame: Day 15
measure: Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
time frame: Day 29
measure: Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
time frame: Day 15
measure: Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
time frame: Day 29
measure: Unanesthetized Schirmer's Test (Pre-CAESM)
time frame: Day 15
measure: Unanesthetized Schirmer's Test (Pre-CAESM)
time frame: Day 29
measure: Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
time frame: Day 1
measure: Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
time frame: Day 15
measure: Ocular Surface Disease Index (OSDI) (Pre-CAESM)
time frame: Day 15
measure: Ocular Surface Disease Index (OSDI) (Pre-CAESM)
time frame: Day 29
measure: Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
time frame: Day 15
measure: Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
time frame: Day 29
measure: Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
time frame: Day 15
measure: Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
time frame: Day 29
measure: Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
time frame: Day 15
measure: Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
time frame: Day 29
measure: Daily diary
time frame: up to Day 29
measure: Visual Acuity (ETDRS) (Pre-CAESM)
time frame: Day -7
measure: Visual Acuity (ETDRS) (Pre-CAESM)
time frame: Day 1
measure: Visual Acuity (ETDRS) (Pre-CAESM)
time frame: Day 15
measure: Visual Acuity (ETDRS) (Pre-CAESM)
time frame: Day 29
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
time frame: Day -7
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
time frame: Day 1
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
time frame: Day 15
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
time frame: Day 29
measure: Adverse event query
time frame: up to Day 29
measure: Dilated Fundoscopy Biomicroscopy
time frame: Day -7
measure: Dilated Fundoscopy Biomicroscopy
time frame: Day 29
measure: Intraocular Pressure
time frame: Day -7
measure: Intraocular Pressure
time frame: Day 29
arm group label: XG-104 low dose
arm group type: Experimental
arm group label: XG-104 intermediate dose
arm group type: Experimental
arm group label: XG-104 high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: XG-104
description: Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
arm group label: XG-104 high dose
arm group label: XG-104 intermediate dose
arm group label: XG-104 low dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca