<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/NCT04499248</url>
  </required_header>
  <id_info>
    <org_study_id>1833-201-407</org_study_id>
    <nct_id>NCT04499248</nct_id>
  </id_info>
  <brief_title>AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension</brief_title>
  <official_title>A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized,&#xD;
      parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in&#xD;
      participants with open-angle glaucoma or ocular hypertension&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Anticipated">April 26, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 26, 2025</primary_completion_date>
  <phase>Phase 1/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>Change from Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye</measure>
    <time_frame>Baseline to Month 24</time_frame>
    <description>IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants experiencing treatment emergent adverse events</measure>
    <time_frame>Baseline to Month 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Rescue Treatment or Re-Treatment in the Study Eye</measure>
    <time_frame>Baseline to Month 24</time_frame>
    <description>Time to rescue treatment or the second treatment is defined as the time between the first treatment and the second treatment in the study eye.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Open-angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Cohort 1 -Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 - Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 -Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-193408 SR</intervention_name>
    <description>An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.</description>
    <arm_group_label>Cohort 1 - Dose B</arm_group_label>
    <arm_group_label>Cohort 1 -Dose A</arm_group_label>
    <arm_group_label>Cohort 2 - Dose A</arm_group_label>
    <arm_group_label>Cohort 2 -Dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lumigan</intervention_name>
    <description>Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost</description>
    <arm_group_label>Cohort 1 - Dose B</arm_group_label>
    <arm_group_label>Cohort 1 -Dose A</arm_group_label>
    <arm_group_label>Cohort 2 - Dose A</arm_group_label>
    <arm_group_label>Cohort 2 -Dose B</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Administration</intervention_name>
    <description>Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.</description>
    <arm_group_label>Cohort 2 - Dose A</arm_group_label>
    <arm_group_label>Cohort 2 -Dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lumigan Vehicle</intervention_name>
    <description>Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.</description>
    <arm_group_label>Cohort 2 - Dose A</arm_group_label>
    <arm_group_label>Cohort 2 -Dose B</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments&#xD;
             according to the study requirements, and in the opinion of the investigator, can do so&#xD;
             without significant risk.&#xD;
&#xD;
          -  Diagnosis of either OAG [open-angle glaucoma] (ie, primary OAG, pseudoexfoliation&#xD;
             glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy or sensitivity to any study medication or its components, any component&#xD;
             of the delivery vehicle, procedure-related materials, or diagnostic agents used during&#xD;
             the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine).&#xD;
&#xD;
          -  Concurrent or anticipated enrollment in an investigational drug or device study or&#xD;
             participation in such a study within 2 months prior to the Baseline visit through the&#xD;
             final study visit.&#xD;
&#xD;
          -  History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC, ENV515&#xD;
             Travoprost XR).&#xD;
&#xD;
          -  History of laser trabeculoplasty within 6 months prior to screening in the study eye.&#xD;
&#xD;
          -  History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic&#xD;
             cataract, traumatic angle recession, etc.) in the study eye.&#xD;
&#xD;
          -  History or evidence of complicated cataract/lens surgery: eg, surgery resulting in&#xD;
             complicated lens placement (such a anterior chamber intraocular lens implant [IOL],&#xD;
             sulcus IOL, aphakia, etc.) or intraoperative complications (such as a posterior&#xD;
             capsular tear [with or without vitreous loss], substantial iris trauma, etc.).&#xD;
&#xD;
          -  Intraocular surgery (including cataract surgery) in the study eye within the 4 months&#xD;
             prior to treatment administration.&#xD;
&#xD;
          -  Any history of corneal graft, including partial grafts (eg, Descemet's Stripping&#xD;
             Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK]);&#xD;
             or incisional refractive surgery (eg, radial keratotomy), other than astigmatic&#xD;
             keratotomy or limbal relaxing incisions in the study eye.&#xD;
&#xD;
          -  History of herpetic ocular diseases in either eye (including herpes simplex virus and&#xD;
             varicella zoster virus).&#xD;
&#xD;
          -  Anticipated need for any incisional or laser ocular surgery in either eye during the&#xD;
             study.&#xD;
&#xD;
          -  History of anatomically narrow angle resulting in evidence of angle changes or any&#xD;
             history or closed angle glaucoma in the study eye.&#xD;
&#xD;
          -  History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the&#xD;
             study eye.&#xD;
&#xD;
          -  Any history of trabeculectomy or other types of incisional glaucoma surgery, including&#xD;
             a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive&#xD;
             glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye.&#xD;
&#xD;
          -  Anticipated use of corticosteroids in either eye except for permitted interventions or&#xD;
             systemically during the study, or historical use prior to Baseline within:&#xD;
&#xD;
               -  3 years: intraocular fluocinolone acetonide&#xD;
&#xD;
               -  6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable&#xD;
                  periocular or sub-Tenon's/subconjunctival corticosteroid&#xD;
&#xD;
               -  2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular&#xD;
                  corticosteroids&#xD;
&#xD;
               -  2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye,&#xD;
                  or adnexa.&#xD;
&#xD;
          -  Anticipated use of other topical ocular medications in either eye except for permitted&#xD;
             interventions.&#xD;
&#xD;
          -  The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes&#xD;
             (Cohort 2) during the study that deviates from the following (contact lens wear is&#xD;
             allowed during the study, but is to be temporarily discontinued before study visits,&#xD;
             and before and after an Administration Day according to the following):&#xD;
&#xD;
               -  Use of soft lenses should be discontinued at least 3 days prior to Baseline, and&#xD;
                  use of rigid gas permeable or hard contact lenses should be discontinued at least&#xD;
                  1 week prior to Baseline&#xD;
&#xD;
               -  Use of soft lenses should be discontinued at least 3 days and use of rigid gas&#xD;
                  permeable or hard contact lenses should be discontinued at least 1 week prior to&#xD;
                  a scheduled study visit or Administration Day visit&#xD;
&#xD;
               -  Use of contact lenses of any kind should be discontinued for 1 week following any&#xD;
                  AGN-193408 SR administration&#xD;
&#xD;
          -  Central corneal thickness of &lt; 480 or &gt; 620 micrometers in both eyes.&#xD;
&#xD;
          -  Visual field loss in the study eye that, in the opinion of the investigator, is&#xD;
             functionally significant (eg, split fixation, field defect within the central 10&#xD;
             degrees that is visually significant or likely to cause central visual impairment upon&#xD;
             progression) or shows evidence of progressive visual field loss within the year prior&#xD;
             to Baseline.&#xD;
&#xD;
          -  Evidence of macular edema in either eye during screening or in participant's medical&#xD;
             history.&#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>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ABBVIE CALL CENTER</last_name>
    <phone>844-663-3742</phone>
    <email>abbvieclinicaltrials@abbvie.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Walman Eye Center /ID# 252153</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Global Research Management /ID# 241699</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204-2500</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>United Medical Research Institute /ID# 241701</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lakeside Vision Center /ID# 241698</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Eye Research Foundation /ID# 234528</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663-3637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sacramento Eye Consultants /ID# 241697</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>916-649-1515</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Premiere Practice Management LLC /ID# 235957</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wolstan &amp; Goldberg Eye Associates /ID# 241700</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Connecticut Eye Consultants P.C. /ID# 235862</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nature Coast Clinical Research - Crystal River /ID# 237781</name>
      <address>
        <city>Crystal River</city>
        <state>Florida</state>
        <zip>34429</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Ophthalmology - Jacksonville /ID# 243122</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209-6533</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>East Florida Eye Institute /ID# 235762</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34994</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Logan Ophthalmic Research Inc. /ID# 252087</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Coastal Research Associates /ID# 234649</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Midwest Medical Advisors Inc /ID# 235845</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Indiana University - Glick Eye Institute /ID# 235887</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston /ID# 236535</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tekwani Vision Center /ID# 235149</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103-2425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northern New Jersey Eye Institute PA /ID# 241545</name>
      <address>
        <city>South Orange</city>
        <state>New Jersey</state>
        <zip>07079-1855</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asheville Eye Associates /ID# 234963</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>James D Branch MD /ID# 234560</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oklahoma Eye Surgeons /ID# 252089</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Drs Fine Hoffman &amp; Sims LLC /ID# 235919</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Scott and Christie and Associates /ID# 252284</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advancing Vision Research /ID# 236683</name>
      <address>
        <city>Smyrna</city>
        <state>Tennessee</state>
        <zip>37167</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. George Eye Center /ID# 236200</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Piedmont Eye Center /ID# 246455</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vistar Eye Center /ID# 234811</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24011</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital /ID# 238880</name>
      <address>
        <city>Sagamihara-shi</city>
        <state>Kanagawa</state>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shimane University Hospital /ID# 238641</name>
      <address>
        <city>Izumo-shi</city>
        <state>Shimane</state>
        <zip>693-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo Hospital /ID# 238871</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Yamanashi Hospital /ID# 238642</name>
      <address>
        <city>Chuo-shi</city>
        <state>Yamanashi</state>
        <zip>409-3821</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Open-angle glaucoma</keyword>
  <keyword>Ocular hypertension</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bimatoprost</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- 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/NCT04499248
org study id: 1833-201-407
nct id: NCT04499248
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized,
      parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in
      participants with open-angle glaucoma or ocular hypertension
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
time frame: Baseline to Month 24
description: IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
measure: Number of participants experiencing treatment emergent adverse events
time frame: Baseline to Month 24
measure: Time to Rescue Treatment or Re-Treatment in the Study Eye
time frame: Baseline to Month 24
description: Time to rescue treatment or the second treatment is defined as the time between the first treatment and the second treatment in the study eye.
arm group label: Cohort 1 -Dose A
arm group type: Experimental
description: Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
arm group label: Cohort 1 - Dose B
arm group type: Experimental
description: Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.
arm group label: Cohort 2 - Dose A
arm group type: Experimental
description: AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
arm group label: Cohort 2 -Dose B
arm group type: Experimental
description: AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.
intervention type: Drug
intervention name: AGN-193408 SR
description: An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.
arm group label: Cohort 1 - Dose B
arm group label: Cohort 1 -Dose A
arm group label: Cohort 2 - Dose A
arm group label: Cohort 2 -Dose B
intervention type: Other
intervention name: Lumigan
description: Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
arm group label: Cohort 1 - Dose B
arm group label: Cohort 1 -Dose A
arm group label: Cohort 2 - Dose A
arm group label: Cohort 2 -Dose B
other name: Active Comparator
intervention type: Other
intervention name: Sham Administration
description: Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
arm group label: Cohort 2 - Dose A
arm group label: Cohort 2 -Dose B
intervention type: Other
intervention name: Lumigan Vehicle
description: Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.
arm group label: Cohort 2 - Dose A
arm group label: Cohort 2 -Dose B
other name: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
last name: ABBVIE CALL CENTER
phone: 844-663-3742
email: abbvieclinicaltrials@abbvie.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Japan
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Bimatoprost
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/