<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/NCT01699464</url>
  </required_header>
  <id_info>
    <org_study_id>AR-12286-CS206</org_study_id>
    <nct_id>NCT01699464</nct_id>
  </id_info>
  <brief_title>A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months</brief_title>
  <official_title>Phase 2b Dose-response of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerie Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerie Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or&#xD;
      timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>Intraocular pressure</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Ocular Hypertension</condition>
  <condition>Open-angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>AR-12286 Ophthalmic Solution 0.7%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AR-12286 Ophthalmic Solution 0.7%, both eyes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR-12286 Ophthalmic Solution 0.5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AR-12286 Ophthalmic Solution 0.5% both eyes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Timolol maleate ophthalmic solution 0.5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Timolol maleate ophthalmic solution 0.5% both eyes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AR-12286 Ophthalmic Solution 0.7%</intervention_name>
    <description>Ophthalmic Solution</description>
    <arm_group_label>AR-12286 Ophthalmic Solution 0.7%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AR-12286 Ophthalmic Solution 0.5%</intervention_name>
    <description>Ophthalmic Solution</description>
    <arm_group_label>AR-12286 Ophthalmic Solution 0.5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Timolol maleate ophthalmic solution 0.5%</intervention_name>
    <description>Ophthalmic Solution</description>
    <arm_group_label>Timolol maleate ophthalmic solution 0.5%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 year of age or greater. (India_ Maximum age of 65 years)&#xD;
&#xD;
          2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).&#xD;
&#xD;
          3. Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days&#xD;
             apart, and ≥ 22 mm Hg at 1000 and 1600 hrs at the second qualification visit. If only&#xD;
             one eye meets the IOP criteria it must be the same eye that met the criteria at all&#xD;
             the qualification timepoints.&#xD;
&#xD;
          4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye&#xD;
             (equivalent to 20/200).&#xD;
&#xD;
          5. Able and willing to give signed informed consent and follow study instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Ophthalmic&#xD;
&#xD;
          1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure&#xD;
             or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.&#xD;
&#xD;
          2. IOP &gt; 36 mm Hg&#xD;
&#xD;
          3. Current use of more than 1 ocular hypotensive medications (Note: fixed dose&#xD;
             combinations are considered multiple medications).&#xD;
&#xD;
          4. Known hypersensitivity to any component of the formulation (benzalkonium chloride,&#xD;
             etc.), or to topical anesthetics.&#xD;
&#xD;
          5. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).&#xD;
&#xD;
          6. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).&#xD;
&#xD;
          7. Ocular trauma within the past six months, or ocular surgery or laser treatment within&#xD;
             the past three months.&#xD;
&#xD;
          8. Evidence of ocular infection, inflammation, clinically significant blepharitis or&#xD;
             conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis&#xD;
&#xD;
          9. Ocular medication of any kind within 30 days of Visit 1, with the exception of a)&#xD;
             ocular hypotensive medications (which must be washed out according to the provided&#xD;
             schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c)&#xD;
             lubricating drops for dry eye (which may be used throughout the study).&#xD;
&#xD;
         10. Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis&#xD;
             sicca) which might interfere with the study, including glaucomatous damage so severe&#xD;
             that washout of ocular hypotensive medications for one month is not judged safe (i.e.,&#xD;
             cup-disc ratio &gt; 0.8).&#xD;
&#xD;
         11. Central corneal thickness greater than 600 µm.&#xD;
&#xD;
         12. Any abnormality preventing reliable applanation tonometry of either eye.&#xD;
&#xD;
             Systemic:&#xD;
&#xD;
             Systemic:&#xD;
&#xD;
         13. Clinically significant abnormalities (as determined by the treating physician) in&#xD;
             laboratory tests at screening.&#xD;
&#xD;
         14. Known hypersensitivity or contraindication to beta adrenoceptor antagonists including&#xD;
             chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood&#xD;
             pressure or heart rate; second or third degree heart block or congestive heart&#xD;
             failure; severe diabetes).&#xD;
&#xD;
         15. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal,&#xD;
             endocrine or cardiovascular disorders) which might interfere with the study.&#xD;
&#xD;
         16. Participation in any investigational study within the past 30 days.&#xD;
&#xD;
         17. Changes of systemic medication that could have a substantial effect on IOP within 30&#xD;
             days prior to screening, or anticipated during the study.&#xD;
&#xD;
         18. Due to the current status of the preclinical safety program, women of childbearing&#xD;
             potential who are pregnant, nursing, planning a pregnancy, or not using a medically&#xD;
             acceptable form of birth control. An adult woman is considered to be of childbearing&#xD;
             potential unless she is one year post-menopausal or three months post-surgical&#xD;
             sterilization. All females of childbearing potential must have a negative urine&#xD;
             pregnancy test result at the screening examination and must not intend to become&#xD;
             pregnant during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Levy, OD</last_name>
    <role>Study Director</role>
    <affiliation>Aerie Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <removed_countries>
    <country>India</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <disposition_first_submitted>February 17, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>February 17, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 17, 2014</disposition_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </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>
  <!-- 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/NCT01699464
org study id: AR-12286-CS206
nct id: NCT01699464
lead sponsor: 
has dmc: No
A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or
      timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3
time frame: Month 3
description: Intraocular pressure
arm group label: AR-12286 Ophthalmic Solution 0.7%
arm group type: Experimental
description: AR-12286 Ophthalmic Solution 0.7%, both eyes
arm group label: AR-12286 Ophthalmic Solution 0.5%
arm group type: Experimental
description: AR-12286 Ophthalmic Solution 0.5% both eyes
arm group label: Timolol maleate ophthalmic solution 0.5%
arm group type: Active Comparator
description: Timolol maleate ophthalmic solution 0.5% both eyes
intervention type: Drug
intervention name: AR-12286 Ophthalmic Solution 0.7%
description: Ophthalmic Solution
arm group label: AR-12286 Ophthalmic Solution 0.7%
intervention type: Drug
intervention name: AR-12286 Ophthalmic Solution 0.5%
description: Ophthalmic Solution
arm group label: AR-12286 Ophthalmic Solution 0.5%
intervention type: Drug
intervention name: Timolol maleate ophthalmic solution 0.5%
description: Ophthalmic Solution
arm group label: Timolol maleate ophthalmic solution 0.5%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Brian Levy, OD
role: Study Director
affiliation: Aerie Pharmaceuticals, Inc.
country: India
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Timolol
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions