xml: <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/NCT06016972</url>
    </required_header>
    <id_info>
      <org_study_id>QC-111-201</org_study_id>
      <nct_id>NCT06016972</nct_id>
    </id_info>
    <brief_title>Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients</brief_title>
    <official_title>A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 vs Timolol Maleate Preservative Free 0.5% Ophthalmic Solution and Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qlaris Bio, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qlaris Bio, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive&#xD;
        efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the&#xD;
        safety and tolerability of QLS-111 versus timolol maleate Preservative Free 0.5% ophthalmic&#xD;
        solution and vehicle in subjects with primary open-angle glaucoma or ocular hypertension.&#xD;
        Primary objective is to evaluate the ocular and systemic safety and tolerability of 3&#xD;
        concentrations of QLS-111 compared to timolol maleate PF 0.5% ophthalmic solution and vehicle&#xD;
        control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3&#xD;
        concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice&#xD;
        daily (BID) dosing versus timolol maleate PF 0.5% ophthalmic solution and vehicle with QAM,&#xD;
        QPM, and BID dosing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 18, 2024</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>
      <intervention_model_description>Multi site double masked, active- and vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111, Timolol, or vehicle. Both eyes (OU) will be dosed.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>21 days</time_frame>
      <description>Ocular safety and tolerability: adverse events (AEs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant change in visual acuity</measure>
      <time_frame>21 days</time_frame>
      <description>Ocular safety and tolerability: visual acuity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant change in findings on slit lamp exam</measure>
      <time_frame>21 days</time_frame>
      <description>Ocular safety and tolerability: slit lamp</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant change in findings on fundus exam</measure>
      <time_frame>21 days</time_frame>
      <description>Ocular safety and tolerability: fundus</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of systemic TEAEs</measure>
      <time_frame>21 days</time_frame>
      <description>Systemic safety and tolerability: AEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant changes in blood pressure (BP)</measure>
      <time_frame>21 days</time_frame>
      <description>Systemic safety and tolerability: vital signs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant changes in heart rate (HR)</measure>
      <time_frame>21 days</time_frame>
      <description>Systemic safety and tolerability: vital signs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye</measure>
      <time_frame>21 days</time_frame>
      <description>Ocular hypotensive efficacy: diurnal IOP CFB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CFB in IOP at various timepoints in the study eye</measure>
      <time_frame>up to 21 days</time_frame>
      <description>Ocular hypotensive efficacy: CFB for multiple timepoints throughout day</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Primary Open Angle Glaucoma (POAG)</condition>
    <condition>Primary Open Angle Glaucoma of Both Eyes</condition>
    <condition>Primary Open-Angle Glaucoma, Unspecified Eye</condition>
    <condition>Ocular Hypertension (OHT)</condition>
    <arm_group>
      <arm_group_label>QLS-111 ophthalmic solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.15%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Timolol maleate Preservative Free 0.5% ophthalmic solution</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Active control. Timolol maleate Preservative Free 0.5% ophthalmic solution, single use vials, masked, PF.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>QLS-111 ophthalmic vehicle solution</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Experimental: QLS-111 ophthalmic solution, (0.015%)</intervention_name>
      <description>QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.</description>
      <arm_group_label>QLS-111 ophthalmic solution</arm_group_label>
      <other_name>QLS-111</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Experimental: QLS-111 ophthalmic solution, (0.03%)</intervention_name>
      <description>QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.</description>
      <arm_group_label>QLS-111 ophthalmic solution</arm_group_label>
      <other_name>QLS-111</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Experimental: QLS-111 ophthalmic solution, (0.075%)</intervention_name>
      <description>QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.</description>
      <arm_group_label>QLS-111 ophthalmic solution</arm_group_label>
      <other_name>QLS-111</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Timolol maleate Preservative Free 0.5% ophthalmic solution</intervention_name>
      <description>Timolol applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.</description>
      <arm_group_label>Timolol maleate Preservative Free 0.5% ophthalmic solution</arm_group_label>
      <other_name>Timolol</other_name>
      <other_name>Timoptic in Ocudose</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>QLS-111 ophthalmic vehicle solution</intervention_name>
      <description>Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.</description>
      <arm_group_label>QLS-111 ophthalmic vehicle solution</arm_group_label>
      <other_name>vehicle</other_name>
      <other_name>placebo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  12 years or older&#xD;
  &#xD;
            -  Able to provide written acknowledgement of giving informed consent&#xD;
  &#xD;
            -  Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with&#xD;
               documented historic IOP value(s) ≥24 mmHg, in either eye&#xD;
  &#xD;
            -  Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  IOP &gt;34 mmHg&#xD;
  &#xD;
            -  Severe glaucomatous damage that would preclude safe washout of prescribed ocular&#xD;
               hypotensive medications&#xD;
  &#xD;
            -  Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes,&#xD;
               cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no&#xD;
               earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed&#xD;
               if done no earlier than 1.5 years from study)&#xD;
  &#xD;
            -  Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye&#xD;
  &#xD;
            -  Use of other ophthalmic concomitant medications during the study&#xD;
  &#xD;
            -  Known hypersensitivity to Timolol&#xD;
  &#xD;
            -  Uncontrolled hypertension or hypotension&#xD;
  &#xD;
            -  Significant systemic or psychiatric disease&#xD;
  &#xD;
            -  Participation in other investigational trial 30 days prior to screening or previous&#xD;
               enrollment and treatment with Qlaris investigational product&#xD;
  &#xD;
            -  Pregnant or lactating&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Brandano</last_name>
      <role>Study Director</role>
      <affiliation>Qlaris Bio, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lisa Brandano</last_name>
      <phone>9789302103</phone>
      <email>lbrandano@qlaris.bio</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Daniel DeWalt</last_name>
      <email>ddewalt@qlaris.bio</email>
    </overall_contact_backup>
    <link>
      <url>https://qlaris.bio</url>
      <description>Company website, pipeline</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Qlaris</keyword>
    <keyword>POAG</keyword>
    <keyword>OHT</keyword>
    <keyword>IOP</keyword>
    <keyword>Glaucoma</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>Timolol</mesh_term>
      <mesh_term>Pharmaceutical Solutions</mesh_term>
      <mesh_term>Ophthalmic Solutions</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016972
  org study id: QC-111-201
  nct id: NCT06016972
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive
        efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
  A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the
        safety and tolerability of QLS-111 versus timolol maleate Preservative Free 0.5% ophthalmic
        solution and vehicle in subjects with primary open-angle glaucoma or ocular hypertension.
        Primary objective is to evaluate the ocular and systemic safety and tolerability of 3
        concentrations of QLS-111 compared to timolol maleate PF 0.5% ophthalmic solution and vehicle
        control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3
        concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice
        daily (BID) dosing versus timolol maleate PF 0.5% ophthalmic solution and vehicle with QAM,
        QPM, and BID dosing.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multi site double masked, active- and vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111, Timolol, or vehicle. Both eyes (OU) will be dosed.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.
  measure: Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
  time frame: 21 days
  description: Ocular safety and tolerability: adverse events (AEs)
  measure: Clinically significant change in visual acuity
  time frame: 21 days
  description: Ocular safety and tolerability: visual acuity
  measure: Clinically significant change in findings on slit lamp exam
  time frame: 21 days
  description: Ocular safety and tolerability: slit lamp
  measure: Clinically significant change in findings on fundus exam
  time frame: 21 days
  description: Ocular safety and tolerability: fundus
  measure: Incidence of systemic TEAEs
  time frame: 21 days
  description: Systemic safety and tolerability: AEs
  measure: Clinically significant changes in blood pressure (BP)
  time frame: 21 days
  description: Systemic safety and tolerability: vital signs
  measure: Clinically significant changes in heart rate (HR)
  time frame: 21 days
  description: Systemic safety and tolerability: vital signs
  measure: Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
  time frame: 21 days
  description: Ocular hypotensive efficacy: diurnal IOP CFB
  measure: CFB in IOP at various timepoints in the study eye
  time frame: up to 21 days
  description: Ocular hypotensive efficacy: CFB for multiple timepoints throughout day
  arm group label: QLS-111 ophthalmic solution
  arm group type: Experimental
  description: Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.15%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF).
  arm group label: Timolol maleate Preservative Free 0.5% ophthalmic solution
  arm group type: Active Comparator
  description: Active control. Timolol maleate Preservative Free 0.5% ophthalmic solution, single use vials, masked, PF.
  arm group label: QLS-111 ophthalmic vehicle solution
  arm group type: Placebo Comparator
  description: Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
  intervention type: Drug
  intervention name: Experimental: QLS-111 ophthalmic solution, (0.015%)
  description: QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  arm group label: QLS-111 ophthalmic solution
  other name: QLS-111
  intervention type: Drug
  intervention name: Experimental: QLS-111 ophthalmic solution, (0.03%)
  description: QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  arm group label: QLS-111 ophthalmic solution
  other name: QLS-111
  intervention type: Drug
  intervention name: Experimental: QLS-111 ophthalmic solution, (0.075%)
  description: QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  arm group label: QLS-111 ophthalmic solution
  other name: QLS-111
  intervention type: Drug
  intervention name: Timolol maleate Preservative Free 0.5% ophthalmic solution
  description: Timolol applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  arm group label: Timolol maleate Preservative Free 0.5% ophthalmic solution
  other name: Timolol
  other name: Timoptic in Ocudose
  intervention type: Other
  intervention name: QLS-111 ophthalmic vehicle solution
  description: Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
  arm group label: QLS-111 ophthalmic vehicle solution
  other name: vehicle
  other name: placebo
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lisa Brandano
  role: Study Director
  affiliation: Qlaris Bio, Inc.
  last name: Lisa Brandano
  phone: 9789302103
  email: lbrandano@qlaris.bio
  last name: Daniel DeWalt
  email: ddewalt@qlaris.bio
  url: https://qlaris.bio
  description: Company website, pipeline
  responsible party type: Sponsor
  mesh term: Glaucoma
  mesh term: Glaucoma, Open-Angle
  mesh term: Ocular Hypertension
  mesh term: Hypertension
  mesh term: Timolol
  mesh term: Pharmaceutical Solutions
  mesh term: Ophthalmic Solutions
  sharing ipd: No