<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/NCT03825081</url>
  </required_header>
  <id_info>
    <org_study_id>17-151H</org_study_id>
    <nct_id>NCT03825081</nct_id>
  </id_info>
  <brief_title>Pilocarpine and Brimonidine in Patients With Monofocal Lenses</brief_title>
  <official_title>Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts Eye and Ear Infirmary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts Eye and Ear Infirmary</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study aims to assess the use of pilocarpine and brimonidine to improve near&#xD;
      visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be&#xD;
      enrolled and baseline visual acuity with be measured at near and distance. This will be&#xD;
      compared to visual acuity after drop administration over 6 hours. A quality of life&#xD;
      questionnaire will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study will try to find out if pilocarpine and brimonidine can help people with&#xD;
      intraocular lens implants read without reading glasses. Thirty-three subjects will take part&#xD;
      in this research study. Baseline visual acuity with be measured at near and distance. This&#xD;
      will be compared to visual acuity after drop administration over 6 hours. A quality of life&#xD;
      questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear&#xD;
      Infirmary (MEEI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>Early Phase 1</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 in visual acuity after administration of pilocarpine and brimonidine</measure>
    <time_frame>baseline; hour 1</time_frame>
    <description>The primary aim of our study is to determine if the combination of pilocarpine and brimonidine improves near visual acuity in pseudophakic subjects 1 hour following drop placement, compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in near and distance visual acuity</measure>
    <time_frame>baseline; hours 1; 3; and 6</time_frame>
    <description>Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Presbyopia</condition>
  <condition>Pseudophakia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventions will be the drugs:&#xD;
pilocarpine - 0.5%&#xD;
brimonidine - 0.2%&#xD;
One drop of each of the study drugs will be placed in the non-dominant eye and patient will be evaluated for adverse events. At hour 1 and 3 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured and patient will be evaluated for adverse events. At hour 6 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured; patient will be evaluated for adverse events; and quality of life/satisfaction survey (NEI RQL-42) will be given to patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine, pilocarpine</intervention_name>
    <description>1 drop of pilocarpine (0.5%)&#xD;
1 drop of brimonidine (0.2%)</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Mirvaso; Alphagan P; Salagen; Isopto Carpine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals must meet all of the inclusion criteria in order to be eligible to&#xD;
             participate in the study. Men and women between ages 60 years and above with monofocal&#xD;
             intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who&#xD;
             need only +/- 2.5 D correction for reading. Given the age group selected only post&#xD;
             menopausal women will be evaluated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals meeting any of the exclusion criteria at baseline will be excluded from&#xD;
             study participation including: allergies to proparacaine, pilocarpine or brimonidine,&#xD;
             eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery&#xD;
             within the past 30 days, use of eye drops within the last seven days, participated in&#xD;
             any other research study within the past 30 days. Patients using contact lenses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Gardiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Matthew_Gardiner@meei.harvard.edu</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matthew Gardiner, MD</last_name>
    <phone>617-573-3202</phone>
    <email>Matthew_Gardiner@meei.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts Eye and Ear</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marisa Tieger, MD</last_name>
      <phone>941-323-9855</phone>
      <email>marisa_tieger@meei.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
    <mesh_term>Pseudophakia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brimonidine Tartrate</mesh_term>
    <mesh_term>Pilocarpine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03825081
org study id: 17-151H
nct id: NCT03825081
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The current study aims to assess the use of pilocarpine and brimonidine to improve near
      visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be
      enrolled and baseline visual acuity with be measured at near and distance. This will be
      compared to visual acuity after drop administration over 6 hours. A quality of life
      questionnaire will also be evaluated.
This research study will try to find out if pilocarpine and brimonidine can help people with
      intraocular lens implants read without reading glasses. Thirty-three subjects will take part
      in this research study. Baseline visual acuity with be measured at near and distance. This
      will be compared to visual acuity after drop administration over 6 hours. A quality of life
      questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear
      Infirmary (MEEI).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in visual acuity after administration of pilocarpine and brimonidine
time frame: baseline; hour 1
description: The primary aim of our study is to determine if the combination of pilocarpine and brimonidine improves near visual acuity in pseudophakic subjects 1 hour following drop placement, compared to baseline.
measure: Change in near and distance visual acuity
time frame: baseline; hours 1; 3; and 6
description: Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.
arm group label: Intervention
arm group type: Experimental
description: Interventions will be the drugs:
pilocarpine - 0.5%
brimonidine - 0.2%
One drop of each of the study drugs will be placed in the non-dominant eye and patient will be evaluated for adverse events. At hour 1 and 3 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured and patient will be evaluated for adverse events. At hour 6 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured; patient will be evaluated for adverse events; and quality of life/satisfaction survey (NEI RQL-42) will be given to patient.
intervention type: Drug
intervention name: Brimonidine, pilocarpine
description: 1 drop of pilocarpine (0.5%)
1 drop of brimonidine (0.2%)
arm group label: Intervention
other name: Mirvaso; Alphagan P; Salagen; Isopto Carpine
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Gardiner, MD
role: Principal Investigator
affiliation: Matthew_Gardiner@meei.harvard.edu
last name: Matthew Gardiner, MD
phone: 617-573-3202
email: Matthew_Gardiner@meei.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Pseudophakia
mesh term: Brimonidine Tartrate
mesh term: Pilocarpine
sharing ipd: No