<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/NCT01719809</url>
  </required_header>
  <id_info>
    <org_study_id>ALR 0054</org_study_id>
    <nct_id>NCT01719809</nct_id>
  </id_info>
  <brief_title>An Evaluation of the Ability to Train Established Glaucoma Patients Who Have Difficulty in Drop Instillation</brief_title>
  <official_title>A Prospective Evaluation of the Effect of Training on Eye Drop Administration in Glaucoma Subjects Who Have Difficulties Properly Instilling Eye Drops</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Robin, Alan L., M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Robin, Alan L., M.D.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, observational, single-center study. Patients with at least 3 months of&#xD;
      experience using topical medications for glaucoma and who state that they administer their&#xD;
      own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial&#xD;
      eye drop, will be identified at the time of a regularly scheduled exam. If the patient can&#xD;
      get a drop onto the eye and also not touch their lids or ocular surface with the eye drop&#xD;
      bottle, the subject will be thanked but not enrolled. All other patients who agree to&#xD;
      participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each&#xD;
      enrolled patient will be shown a video demonstrating an instillation technique and will be&#xD;
      given an instructional handout highlighting a proper drop instillation technique. If&#xD;
      necessary, an instillation technique will be demonstrated to them by an investigator or&#xD;
      trained personnel.&#xD;
&#xD;
      A patient will be identified as properly instilling a drop if they satisfy the following&#xD;
      criteia:&#xD;
&#xD;
      They are able to instill one (and only one) drop to the ocular surface or lower fornix&#xD;
      without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.&#xD;
&#xD;
      All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the&#xD;
      investigator or trained personnel would direct the patient to instill an eye drop into the&#xD;
      study eye.Additionally, the short glaucoma self-efficacy questionnaire will be&#xD;
      re-administered.&#xD;
&#xD;
      All of the video-recordings of participants' eye drop instillation techniques will be&#xD;
      reviewed and assessed using a standard checklist. Their ability to administer an eye drop&#xD;
      after training will be compared to baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment Goals not met&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 1, 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ability to administer an eye drop according to our criteria, as outlined in our study summary.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">18</enrollment>
  <condition>Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Private Ophthalmology Office (Specialty-Glaucoma)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years or older&#xD;
&#xD;
          -  Patients currently using topical ocular antihypertensive medications at the time of&#xD;
             enrollment in at least one eye, and who have been using these drops consistently for a&#xD;
             period of at least three months prior to enrollment.&#xD;
&#xD;
          -  Patients with primary open angle glaucoma, pigmentary glaucoma, exfoliation glaucoma,&#xD;
             ocular hypertension, normal-tension glaucoma, neovascular glaucoma, uveitic glaucoma&#xD;
             and chronic narrow angle glaucoma.&#xD;
&#xD;
          -  Patients CAN be enrolled even if they have co-existing morbidities such as Parkinson's&#xD;
             Disease or arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not instill their own eye drops&#xD;
&#xD;
          -  Patients who are not expected to still be using topical antihypertensive medications&#xD;
             at the time of study follow-up&#xD;
&#xD;
          -  Patients with no light perception vision&#xD;
&#xD;
          -  Patients with a history of adverse reaction to artificial tears or any component of&#xD;
             artificial tears&#xD;
&#xD;
          -  Patients who have a typical follow-up period of greater than 6 months&#xD;
&#xD;
          -  Patients who have not completed a Humphrey Visual Field C24-2 or C10-2 within 7 months&#xD;
             of enrollment or study exit.&#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>Adam C LePosa, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alan L. Robin, MD, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alan L. Robin, MD, PA</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Robin, Alan L., M.D.</investigator_affiliation>
    <investigator_full_name>Adam C. LePosa</investigator_full_name>
    <investigator_title>Adam C. LePosa, O.D</investigator_title>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Eye Drop</keyword>
  <keyword>Eye Drop Technique</keyword>
  <keyword>Training</keyword>
  <keyword>Instilling Eye Drops</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>
  </condition_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/NCT01719809
org study id: ALR 0054
nct id: NCT01719809
lead sponsor: 
has dmc: Yes
This is a prospective, observational, single-center study. Patients with at least 3 months of
      experience using topical medications for glaucoma and who state that they administer their
      own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial
      eye drop, will be identified at the time of a regularly scheduled exam. If the patient can
      get a drop onto the eye and also not touch their lids or ocular surface with the eye drop
      bottle, the subject will be thanked but not enrolled. All other patients who agree to
      participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each
      enrolled patient will be shown a video demonstrating an instillation technique and will be
      given an instructional handout highlighting a proper drop instillation technique. If
      necessary, an instillation technique will be demonstrated to them by an investigator or
      trained personnel.

      A patient will be identified as properly instilling a drop if they satisfy the following
      criteia:

      They are able to instill one (and only one) drop to the ocular surface or lower fornix
      without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.

      All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the
      investigator or trained personnel would direct the patient to instill an eye drop into the
      study eye.Additionally, the short glaucoma self-efficacy questionnaire will be
      re-administered.

      All of the video-recordings of participants' eye drop instillation techniques will be
      reviewed and assessed using a standard checklist. Their ability to administer an eye drop
      after training will be compared to baseline.
observational model: Other
time perspective: Prospective
measure: Ability to administer an eye drop according to our criteria, as outlined in our study summary.
time frame: 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam C LePosa, OD
role: Principal Investigator
affiliation: Alan L. Robin, MD, PA
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Robin, Alan L., M.D.
investigator full name: Adam C. LePosa
investigator title: Adam C. LePosa, O.D
mesh term: Glaucoma
mesh term: Ocular Hypertension