<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/NCT01696383</url>
  </required_header>
  <id_info>
    <org_study_id>RDG-11-257</org_study_id>
    <nct_id>NCT01696383</nct_id>
  </id_info>
  <brief_title>Assessing the Efficacy of DuoTrav as a Replacement Therapy in Glaucoma Patients in Russia</brief_title>
  <official_title>Assessing the Efficacy of DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination), as a Replacement Therapy in Glaucoma Patients in Russia, Previously on Prior Prostaglandin Analogue or Beta-blocker Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost&#xD;
      0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian&#xD;
      glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure&#xD;
      (IOP) is uncontrolled while on their current treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Management decision&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline (Day 0) in intraocular pressure (IOP) at final visit (Week 12)</measure>
    <time_frame>Baseline (Day 0), Week 12</time_frame>
    <description>As measured by Goldmann applanation tonometry. If only one eye qualifies for inclusion and treatment, this eye will be selected for analysis. If both eyes qualify and are treated, the worse evaluable eye will be selected for analysis. The worse eye will be the eye with the higher IOP at the screening/baseline visit. If both eyes are equal, the right eye will be selected for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who reach target IOP (≤18 mmHg)</measure>
    <time_frame>Week 12</time_frame>
    <description>As measured by Goldmann applanation tonometry.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>DuoTrav</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)</intervention_name>
    <description>One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks</description>
    <arm_group_label>DuoTrav</arm_group_label>
    <other_name>DuoTrav®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of ocular hypertension, primary open-angle glaucoma and&#xD;
             pseudoexfoliative or pigment dispersion glaucoma.&#xD;
&#xD;
          -  Be on a stable IOP-lowering regimen of prostaglandin analogue or beta-blocker&#xD;
             (monotherapy) within 4 weeks prior to the Screening Visit.&#xD;
&#xD;
          -  Have IOP considered to be safe (in the opinion of the investigator), in both eyes, in&#xD;
             such a way that should assure clinical stability of vision and the optic nerve&#xD;
             throughout the study period.&#xD;
&#xD;
          -  Have an IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye&#xD;
             (which would be designated as the study eye). In any eye not designated as a study&#xD;
             eye, the IOP should be able to be controlled on no pharmacologic therapy or on the&#xD;
             study medicine alone.&#xD;
&#xD;
          -  Willing to discontinue the use of all other ocular hypotensive medication(s) prior to&#xD;
             receiving the study medication for the entire course of the study.&#xD;
&#xD;
          -  Able to follow instructions and willing and able to attend all study visits.&#xD;
&#xD;
          -  Have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in&#xD;
             each eye.&#xD;
&#xD;
          -  Read, sign, and date an Ethics Committee reviewed and approved informed consent form.&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known medical history of allergy, hypersensitivity or poor tolerance to any component&#xD;
             of DuoTrav® that is deemed clinically significant in the opinion of the Principal&#xD;
             Investigator.&#xD;
&#xD;
          -  Any abnormality preventing reliable applanation tonometry in either eye.&#xD;
&#xD;
          -  Corneal dystrophies in either eye.&#xD;
&#xD;
          -  Any opacity or subject uncooperativeness that restricts adequate examination of the&#xD;
             anterior chamber of either eye.&#xD;
&#xD;
          -  Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either&#xD;
             eye. Blepharitis or non-clinically significant conjunctival injection is allowed.&#xD;
&#xD;
          -  History of ocular herpes simplex infection.&#xD;
&#xD;
          -  Intraocular conventional surgery or laser surgery in either eye that is less than&#xD;
             three months prior to the Screening Visit.&#xD;
&#xD;
          -  Risk of visual field or visual acuity worsening as a consequence of participation in&#xD;
             the study, in the investigator's best judgment.&#xD;
&#xD;
          -  Progressive retinal or optic nerve disease from any cause apart from glaucoma.&#xD;
&#xD;
          -  Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers,&#xD;
             alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium&#xD;
             channel blockers), which have not been on a stable course for 7 days prior to&#xD;
             Screening Visit or an anticipated change in the dosage during the course of the study.&#xD;
&#xD;
          -  Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive&#xD;
             pulmonary disease that would preclude the safe administration of a topical&#xD;
             beta-blocker.&#xD;
&#xD;
          -  History of severe allergic rhinitis.&#xD;
&#xD;
          -  Unwillingness to risk the possibility of darkened iris or eyelash changes.&#xD;
&#xD;
          -  Women of childbearing potential not using reliable means of birth control for at least&#xD;
             one month prior to the Screening/Baseline Visit.&#xD;
&#xD;
          -  Women who are pregnant or lactating.&#xD;
&#xD;
          -  Participation in any other investigational study within 30 days prior to the Screening&#xD;
             Visit.&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#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>Abayomi Ogundele, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>February 6, 2013</last_update_submitted>
  <last_update_submitted_qc>February 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraocular Pressure (IOP)</keyword>
  <keyword>Glaucoma</keyword>
  <keyword>Ocular hypertension</keyword>
  <keyword>DuoTrav</keyword>
  <keyword>Prostaglandin analogue</keyword>
  <keyword>Beta-blocker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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>Travoprost</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/NCT01696383
org study id: RDG-11-257
nct id: NCT01696383
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost
      0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian
      glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure
      (IOP) is uncontrolled while on their current treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline (Day 0) in intraocular pressure (IOP) at final visit (Week 12)
time frame: Baseline (Day 0), Week 12
description: As measured by Goldmann applanation tonometry. If only one eye qualifies for inclusion and treatment, this eye will be selected for analysis. If both eyes qualify and are treated, the worse evaluable eye will be selected for analysis. The worse eye will be the eye with the higher IOP at the screening/baseline visit. If both eyes are equal, the right eye will be selected for analysis.
measure: Percentage of subjects who reach target IOP (≤18 mmHg)
time frame: Week 12
description: As measured by Goldmann applanation tonometry.
arm group label: DuoTrav
arm group type: Experimental
description: One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks
intervention type: Drug
intervention name: Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)
description: One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks
arm group label: DuoTrav
other name: DuoTrav®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abayomi Ogundele, PharmD
role: Study Director
affiliation: Alcon Research
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Timolol
mesh term: Travoprost