<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/NCT01721707</url>
  </required_header>
  <id_info>
    <org_study_id>BRINZLAT-12</org_study_id>
    <secondary_id>08233812.4.0000.5505</secondary_id>
    <nct_id>NCT01721707</nct_id>
  </id_info>
  <brief_title>Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH</brief_title>
  <official_title>Safety and Efficacy to Reduce the IOP of the Fixed Association of Latanoprost 0.005% (50 μg/mL)/ Brinzolamide 1% (10mg/mL) Drops, Compared to Latanoprost 0.005% (50 μg/mL) Drops, in Patients With Open Angle Glaucoma or Ocular Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adapt Produtos Oftalmológicos Ltda.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adapt Produtos Oftalmológicos Ltda.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a double-masked, randomized, parallel group study in patients with open angle&#xD;
      glaucoma or ocular hypertension.&#xD;
&#xD;
      The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50&#xD;
      mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in&#xD;
      reducing IOP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is divided into two sequential phases. The Phase I trial is a Phase Screening /&#xD;
      Eligibility, which includes a screening visit, followed by 2 Visits Eligibility (3 visits).&#xD;
      The Phase II study is the treatment phase randomized, double-masked that includes visits&#xD;
      during therapy at Week 2, Week 6 and Month 3&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    withdrawn by industry&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP</measure>
    <time_frame>Month 3</time_frame>
    <description>Change in mean diurnal IOP compared to baseline (Month 3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IOP changes</measure>
    <time_frame>week 2, week 6, month 3</time_frame>
    <description>Change in mean IOP from baseline (week 2, week 6, month 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP measures</measure>
    <time_frame>week 2, week 6, month 3</time_frame>
    <description>Percentage of patients with IOP &lt;18 mmHg at each visit during therapy and timepoint (week 2, week 6, month 3)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomicroscopy / Fundus examination</measure>
    <time_frame>Week 2, Week 6, Month 3</time_frame>
    <description>relevant changes observed by physician during biomicroscopy and fundus examination</description>
  </other_outcome>
  <other_outcome>
    <measure>BCVA</measure>
    <time_frame>Week 2, Week 6, Month 3</time_frame>
    <description>Decrease of visual acuity observed by BCVA examination</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>Latanoprost+Brinzolamide combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Latanoprost 0.005%(50 mg/ml)+brinzolamide 1%(10mg/ml) eye drops</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Latanoprost 0.005% (50 mg / ml)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost+Brinzolamide combination</intervention_name>
    <description>1 drop in each eye, 1x/day, at 9PM</description>
    <arm_group_label>Latanoprost+Brinzolamide combination</arm_group_label>
    <other_name>Latanoprost 0.005% (50 mg / ml) / brinzolamide 1% (10mg/ml) eye drops</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost</intervention_name>
    <description>1 drop in each eye, 1x/day, at 9PM</description>
    <arm_group_label>Latanoprost</arm_group_label>
    <other_name>Latanoprost 0.005% (50 mg / ml)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age or older, of either gender and of any race / ethnicity,&#xD;
             diagnosed with open angle glaucoma or ocular hypertension, which in the opinion of the&#xD;
             investigator does not have enough control with monotherapy or already receiving&#xD;
             multiple medications for lowering IOP .&#xD;
&#xD;
          -  Patients should be able to understand and sign an informed consent form that has been&#xD;
             approved by an Institutional Review Board.&#xD;
&#xD;
          -  Measurements of mean IOP in at least 1 eye:&#xD;
&#xD;
               -  ≥ 24 mmHg and ≤ 36 mmHg at timepoint 9am and&#xD;
&#xD;
               -  ≥ 21 mmHg and ≤ 36 mmHg in the 11h timepoint in both Visits Eligibility 1 and&#xD;
                  after washout of any medication to reduce IOP.&#xD;
&#xD;
          -  The mean IOP should not be&gt; 36 mmHg at any timepoint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fertile women (those not surgically sterile or postmenopausal for at least 1 year) are&#xD;
             excluded from study participation if meet any of the following conditions:&#xD;
&#xD;
               1. currently pregnant or&#xD;
&#xD;
               2. have tested positive in urine pregnancy Screening Visit or&#xD;
&#xD;
               3. planning to become pregnant during the study period, or&#xD;
&#xD;
               4. are breastfeeding, or not using highly effective contraceptive precautions.&#xD;
&#xD;
          -  Patients with angle Schaffer Grade &lt;2, as measured by gonioscopy (extreme narrow angle&#xD;
             with complete or partial closure).&#xD;
&#xD;
          -  Patients with a ratio cup / disc greater than 0.80 (horizontal or vertical).&#xD;
&#xD;
          -  Patients presenting with loss of central visual field impairment. The loss of central&#xD;
             visual field is defined as a serious sensitivity less than or equal to 10 dB in at&#xD;
             least four points of two visual field test closest to the point of attachment.&#xD;
&#xD;
          -  Patients who can not safely discontinue use of all medications to ocular IOP reduction&#xD;
             for a minimum of 5 days ± 1 day to 28 days ± 1 day prior to Visit E1.&#xD;
&#xD;
          -  Chronic inflammatory eye disease, recurrent or severe (ie, scleritis, uveitis,&#xD;
             herpetic keratitis).&#xD;
&#xD;
          -  Ocular trauma in the past 6 months.&#xD;
&#xD;
          -  Eye infection or inflammation of the eye in the last 3 months.&#xD;
&#xD;
          -  Retinal disease as clinically significant or progressive retinal degeneration,&#xD;
             diabetic retinopathy or retinal detachment.&#xD;
&#xD;
          -  Best score corrected visual acuity (BCVA) worse than 55 ETDRS letters (equivalent to&#xD;
             approximately 20/80 Snellen).&#xD;
&#xD;
          -  Another ocular pathology (including severe dry eye) that may, in the opinion of the&#xD;
             investigator, preventing the administration of an alpha-adrenergic agonist and/or an&#xD;
             inhibitor of topical carbonic anhydrase (CAI).&#xD;
&#xD;
          -  Intraocular surgery within the last 6 months.&#xD;
&#xD;
          -  Laser eye surgery in the last 3 months.&#xD;
&#xD;
          -  Any abnormality that prevents a reliable applanation tonometry.&#xD;
&#xD;
          -  Any other condition including severe illness that would make the patient, in the&#xD;
             opinion of the investigator, unsuitable for the study.&#xD;
&#xD;
          -  History of cardiovascular disease (eg, coronary heart disease, hypertension, Raynaud's&#xD;
             phenomenon, orthostatic hypotension, thromboangiitis), cerebrovascular (eg, cerebral&#xD;
             insufficiency), active liver or kidney, severe, unstable or uncontrolled that would&#xD;
             prevent the safe administration of an alpha-adrenergic topic or CAI in the opinion of&#xD;
             the investigator.&#xD;
&#xD;
        Related to previous or concomitant medications&#xD;
&#xD;
          -  Patients with recent use (within 4 weeks of Visit Eligibility 1) salicylate therapy&#xD;
             with high dose (&gt; 1 g daily).&#xD;
&#xD;
          -  Current or planned treatment with any psychotropic drug that increases the adrenergic&#xD;
             response (eg, desipramine, amitriptyline).&#xD;
&#xD;
          -  Concomitant use of monoamine oxidase inhibitors.&#xD;
&#xD;
          -  Therapy with another investigational agent within 30 days prior to the Screening&#xD;
             Visit.&#xD;
&#xD;
          -  Hypersensitivity to the drug alpha-adrenergic agonists, oral or topical CAIs,&#xD;
             sulfonamide derivatives or any component of the study drugs in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Less than 30 days regimen with stable administration before the Screening Visit any&#xD;
             medications or substances administered by any route and used chronically that may&#xD;
             affect IOP, including among others, β-adrenergic blocking agents.&#xD;
&#xD;
          -  Use of ocular hypotensive medication any additional topical or systemic throughout the&#xD;
             study.&#xD;
&#xD;
          -  Concomitant use of glucocorticoids administered by any route.&#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>Rubens Belfort Jr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo / Hospital São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology / Hospital São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04023062</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glaucoma</keyword>
  <keyword>ocular hypertension</keyword>
  <keyword>latanoprost</keyword>
  <keyword>brinzolamide</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>Latanoprost</mesh_term>
    <mesh_term>Brinzolamide</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/NCT01721707
org study id: BRINZLAT-12
secondary id: 08233812.4.0000.5505
nct id: NCT01721707
lead sponsor: 
has dmc: No
This study is a double-masked, randomized, parallel group study in patients with open angle
      glaucoma or ocular hypertension.

      The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50
      mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in
      reducing IOP
The study is divided into two sequential phases. The Phase I trial is a Phase Screening /
      Eligibility, which includes a screening visit, followed by 2 Visits Eligibility (3 visits).
      The Phase II study is the treatment phase randomized, double-masked that includes visits
      during therapy at Week 2, Week 6 and Month 3
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: IOP
time frame: Month 3
description: Change in mean diurnal IOP compared to baseline (Month 3)
measure: IOP changes
time frame: week 2, week 6, month 3
description: Change in mean IOP from baseline (week 2, week 6, month 3)
measure: IOP measures
time frame: week 2, week 6, month 3
description: Percentage of patients with IOP <18 mmHg at each visit during therapy and timepoint (week 2, week 6, month 3)
measure: Biomicroscopy / Fundus examination
time frame: Week 2, Week 6, Month 3
description: relevant changes observed by physician during biomicroscopy and fundus examination
measure: BCVA
time frame: Week 2, Week 6, Month 3
description: Decrease of visual acuity observed by BCVA examination
arm group label: Latanoprost+Brinzolamide combination
arm group type: Experimental
description: Latanoprost 0.005%(50 mg/ml)+brinzolamide 1%(10mg/ml) eye drops
arm group label: Latanoprost
arm group type: Active Comparator
description: Latanoprost 0.005% (50 mg / ml)
intervention type: Drug
intervention name: Latanoprost+Brinzolamide combination
description: 1 drop in each eye, 1x/day, at 9PM
arm group label: Latanoprost+Brinzolamide combination
other name: Latanoprost 0.005% (50 mg / ml) / brinzolamide 1% (10mg/ml) eye drops
intervention type: Drug
intervention name: Latanoprost
description: 1 drop in each eye, 1x/day, at 9PM
arm group label: Latanoprost
other name: Latanoprost 0.005% (50 mg / ml)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rubens Belfort Jr, MD
role: Principal Investigator
affiliation: Federal University of São Paulo / Hospital São Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Latanoprost
mesh term: Brinzolamide