<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/NCT02235272</url>
  </required_header>
  <id_info>
    <org_study_id>SDD-1002-064</org_study_id>
    <nct_id>NCT02235272</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation</brief_title>
  <official_title>A Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Phase III Study of the Efficacy and Safety of a Single Sub-conjunctival Injection of XG-102 for the Reduction of Post-cataract Surgery Intraocular Inflammation</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 purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)&#xD;
      compared to vehicle in the treatment of subjects with inflammation and pain following&#xD;
      cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle</measure>
    <time_frame>Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of pain for the 900µg XG-102 compared to vehicle</measure>
    <time_frame>Day2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of rescue medication</measure>
    <time_frame>up to Day 85</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Specular microscopy</measure>
    <time_frame>Day 85</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse event (AE) monitoring</measure>
    <time_frame>up to Day 85</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">339</enrollment>
  <condition>Inflammation</condition>
  <condition>Pain</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>XG-102</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>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XG-102</intervention_name>
    <description>Comparison of XG-102 versus placebo sub-conjunctival injection efficacy</description>
    <arm_group_label>XG-102</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>comparison of XG-102 versus placebo sub-conjunctival injection efficacy</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Have provided written informed consent, approved by the appropriate institutional&#xD;
             review board;&#xD;
&#xD;
          -  Be greater than or equal to 18 years of age of either sex or any race;&#xD;
&#xD;
          -  Be planning to undergo unilateral cataract extraction via phacoemulsification and&#xD;
             posterior chamber intraocular lens (PCIOL) implantation in the study eye;&#xD;
&#xD;
          -  Have a pin-hole visual acuity (VA) &lt; 1.0 logarithm of the minimum angle of resolution&#xD;
             (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for&#xD;
             Diabetic Retinopathy Study (ETDRS) chart at Visit 1;&#xD;
&#xD;
          -  (For females of childbearing potential) agree to have urine pregnancy testing&#xD;
             performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and&#xD;
             must agree to use a medically acceptable form of birth control1 throughout the study&#xD;
             duration. Women of childbearing potential include all females who have experienced&#xD;
             menarche and have not experienced menopause (as defined by amenorrhea for greater than&#xD;
             12 consecutive months) or have not undergone successful surgical sterilization&#xD;
             (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Have a known sensitivity or allergy to the class of medication of the active&#xD;
             ingredient in the study medication or any of the study medication's components;&#xD;
&#xD;
          -  Have any intraocular inflammation (e.g., white blood cells or flare) present in the&#xD;
             study eye at the Visit 1slit lamp examination;&#xD;
&#xD;
          -  Have a score greater than &quot;0&quot; on the Ocular Pain Assessment at Visit 1 or 2 in the&#xD;
             study eye;&#xD;
&#xD;
          -  Have an immunosuppressive or an autoimmune disease that in the opinion of the&#xD;
             Investigator could affect intraocular inflammation or the normal healing process of&#xD;
             the eye;&#xD;
&#xD;
          -  Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and&#xD;
             will likely affect wound healing;&#xD;
&#xD;
          -  Currently have suspected or known malignancy or be currently receiving antineoplastic&#xD;
             therapy;&#xD;
&#xD;
          -  Be a female who is currently pregnant, planning a pregnancy, lactating, not using a&#xD;
             medically acceptable form of birth control throughout the study duration, or have a&#xD;
             positive urine pregnancy test at Visit 1;&#xD;
&#xD;
          -  Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics&#xD;
             and other pain medications) or immunomodulating agents, systemically, or in either&#xD;
             eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout&#xD;
             period through the duration of the study&#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>Steven M Silverstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Silverstein Eye Centers</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92843</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</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>January 23, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>January 23, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 24, 2017</disposition_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</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>Cataract</mesh_term>
    <mesh_term>Uveitis</mesh_term>
    <mesh_term>Inflammation</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/NCT02235272
org study id: SDD-1002-064
nct id: NCT02235272
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)
      compared to vehicle in the treatment of subjects with inflammation and pain following
      cataract surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle
time frame: Day 15
measure: Absence of pain for the 900µg XG-102 compared to vehicle
time frame: Day2
measure: Use of rescue medication
time frame: up to Day 85
measure: Specular microscopy
time frame: Day 85
measure: Adverse event (AE) monitoring
time frame: up to Day 85
arm group label: XG-102
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: XG-102
description: Comparison of XG-102 versus placebo sub-conjunctival injection efficacy
arm group label: XG-102
intervention type: Drug
intervention name: Placebo
description: comparison of XG-102 versus placebo sub-conjunctival injection efficacy
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven M Silverstein, MD
role: Principal Investigator
affiliation: Silverstein Eye Centers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Uveitis
mesh term: Inflammation