<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/NCT04483882</url>
  </required_header>
  <id_info>
    <org_study_id>20-0087</org_study_id>
    <nct_id>NCT04483882</nct_id>
  </id_info>
  <brief_title>Tactile Low Vision Labeling of Ophthalmic Drops</brief_title>
  <official_title>Utility and Efficacy of Tactile Labeling of Ophthalmic Drops for Identity and Frequency of Administration in Low Vision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is an evaluation of a tactile labeling strategy developed in the&#xD;
      Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in&#xD;
      collaboration with the UTMB Maker Space to improve low vision patients capability to identify&#xD;
      their topical ophthalmic drop treatments and the frequency with which they should be&#xD;
      administered. The labeling strategy includes protrusions as frequency markers and shapes to&#xD;
      differentiate between treatments of similar frequency prescription.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is an evaluation of a tactile labeling strategy developed in the&#xD;
      Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in&#xD;
      collaboration with the UTMB Maker Space to improve low vision patients capability to identify&#xD;
      their topical ophthalmic drop treatments and the frequency with which they should be&#xD;
      administered. The labeling strategy includes protrusions as frequency markers and shapes to&#xD;
      differentiate between treatments of similar frequency prescription.&#xD;
&#xD;
      The first aim is to evaluate the patient capability to identify the number of protrusions and&#xD;
      therefore the frequency of administration prescribed. This should be completed in a timeframe&#xD;
      that is not frustrating or problematic to the patient in practice.&#xD;
&#xD;
      The second aim is to evaluate the patient ability to differentiate between drugs with similar&#xD;
      frequencies based on a shape on the frequency protrusions in a tactile manner. This also&#xD;
      should be completed in a timeframe that is not over burdensome or frustrating to the patient.&#xD;
      The protocol is designed to evaluate this tactile labeling design in the population it is&#xD;
      designed to support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Group, Blinded, Sham controlled study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects will be blinded to product to be provided for visual and tactile definition of label product and type and frequency of prescription.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Correct Drug Identity by Shape</measure>
    <time_frame>2 minutes</time_frame>
    <description>Subjects Assessment and Report of drug identity by shape of label protrusions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correct Drug Identity by Color</measure>
    <time_frame>2 minutes</time_frame>
    <description>Subject Assessment and Report of drug identity by color of tactile label</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correct Dose Frequency by Tactile Protrusions</measure>
    <time_frame>2 minutes</time_frame>
    <description>Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Low Vision Aids</condition>
  <arm_group>
    <arm_group_label>Phase I- Visually Obscured Healthy Subjects</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Tactile label to be evaluated by healthy subjects without visual defect. Subjects in visually obscuring lenses but without peripheral neuropathies or other tactile deficits will evaluate the tactile labeling product for efficacy in drug identity and dosing definition. .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II- Low Vision Over 50 years of age</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects with documented Low Vision of 20/70 or less or visual field less than 20 degrees will be asked to evaluate tactile labeling product for efficacy in drug identity and dosing definition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tactile Labels for Drug identity and dose frequency</intervention_name>
    <description>The tactile labeling proposed in this protocol is rigid labeling. A ring-clip has an inner diameter of 12.5cm, an outer diameter of 16 cm, and a height of 1.5 cm. The ring is cut at 2 cm to form a semi-circle allowing it to be clipped onto the bottleneck. The ring clip fits most if not all prescription eye drop bottles. The individual protrusions with shapes at the end can be cut off by the pharmacist to match the frequency of administration prescribed.</description>
    <arm_group_label>Phase I- Visually Obscured Healthy Subjects</arm_group_label>
    <arm_group_label>Phase II- Low Vision Over 50 years of age</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        IInclusion Criteria:&#xD;
&#xD;
        Phase I:&#xD;
&#xD;
          -  Candidates will be healthy adults between 18 and 100 years of age&#xD;
&#xD;
          -  Candidates will complete the consent briefing and consent documents prior to&#xD;
             participating in any study activities.&#xD;
&#xD;
          -  Phase II:Inclusion Criteria:&#xD;
&#xD;
          -  Candidates will be between 50 and 100 years of age.&#xD;
&#xD;
          -  Candidates will have a BCVA equal to or less than 20/70 or have central vision field&#xD;
             less than 20 degrees.&#xD;
&#xD;
          -  Candidates will complete the consent briefing and consent documents prior to&#xD;
             participating in any study activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Phase I:&#xD;
&#xD;
          -  Candidates who do not complete the consent briefing and indicate consent through&#xD;
             completion of consent documents with or without a witness (as indicated by their&#xD;
             ability to read the documents for themselves out loud with whatever optical assistance&#xD;
             necessary (large print, magnification, optical correction, etc.), prior to any study&#xD;
             activity, will not be included in this study.&#xD;
&#xD;
          -  History of prior non-compliance or the presence or history of psychiatric condition&#xD;
             (including drug or alcohol addiction) that would, in the opinion of the investigator,&#xD;
             make it difficult for the subject to comply with the study procedures or follow the&#xD;
             investigators instructions.&#xD;
&#xD;
        Phase II;&#xD;
&#xD;
          -  Candidates under 50 years or older than 100 years of age will be excluded.&#xD;
&#xD;
          -  Candidates with a BCVA better than 20/70 or have central vision field greater than 20&#xD;
             degrees, will be excluded.&#xD;
&#xD;
          -  Candidates with comorbidities that in the opinion of the investigator confound their&#xD;
             ability to complete the assessments in this study (ie. Advanced neuropathy of the&#xD;
             hands, dementia, or mental incapacity) will be excluded.&#xD;
&#xD;
          -  Candidates who do not complete the consent briefing and indicate consent through&#xD;
             completion of consent documents with or without a witness (as indicated by their&#xD;
             ability to read the documents for themselves out loud with whatever optical assistance&#xD;
             necessary (large print, magnification, optical correction, etc.), prior to any study&#xD;
             activity, will not be included in this study.&#xD;
&#xD;
          -  History of prior non-compliance or the presence or history of psychiatric condition&#xD;
             (including drug or alcohol addiction) that would, in the opinion of the investigator,&#xD;
             make it difficult for the subject to comply with the study procedures or follow the&#xD;
             investigators instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Praveena Gupta, O.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch, Ophthalmology Clinical Research Center</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>December 22, 2021</last_update_submitted>
  <last_update_submitted_qc>December 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Vision, Labeling, Tactile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision, Low</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual's data will not be shared in an identifiable format.</ipd_description>
  </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/NCT04483882
org study id: 20-0087
nct id: NCT04483882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is an evaluation of a tactile labeling strategy developed in the
      Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in
      collaboration with the UTMB Maker Space to improve low vision patients capability to identify
      their topical ophthalmic drop treatments and the frequency with which they should be
      administered. The labeling strategy includes protrusions as frequency markers and shapes to
      differentiate between treatments of similar frequency prescription.
The purpose of this study is an evaluation of a tactile labeling strategy developed in the
      Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in
      collaboration with the UTMB Maker Space to improve low vision patients capability to identify
      their topical ophthalmic drop treatments and the frequency with which they should be
      administered. The labeling strategy includes protrusions as frequency markers and shapes to
      differentiate between treatments of similar frequency prescription.

      The first aim is to evaluate the patient capability to identify the number of protrusions and
      therefore the frequency of administration prescribed. This should be completed in a timeframe
      that is not frustrating or problematic to the patient in practice.

      The second aim is to evaluate the patient ability to differentiate between drugs with similar
      frequencies based on a shape on the frequency protrusions in a tactile manner. This also
      should be completed in a timeframe that is not over burdensome or frustrating to the patient.
      The protocol is designed to evaluate this tactile labeling design in the population it is
      designed to support.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Single Group, Blinded, Sham controlled study
primary purpose: Other
masking: Single (Participant)
masking description: Subjects will be blinded to product to be provided for visual and tactile definition of label product and type and frequency of prescription.
measure: Correct Drug Identity by Shape
time frame: 2 minutes
description: Subjects Assessment and Report of drug identity by shape of label protrusions
measure: Correct Drug Identity by Color
time frame: 2 minutes
description: Subject Assessment and Report of drug identity by color of tactile label
measure: Correct Dose Frequency by Tactile Protrusions
time frame: 2 minutes
description: Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label
arm group label: Phase I- Visually Obscured Healthy Subjects
arm group type: Sham Comparator
description: Tactile label to be evaluated by healthy subjects without visual defect. Subjects in visually obscuring lenses but without peripheral neuropathies or other tactile deficits will evaluate the tactile labeling product for efficacy in drug identity and dosing definition. .
arm group label: Phase II- Low Vision Over 50 years of age
arm group type: Active Comparator
description: Subjects with documented Low Vision of 20/70 or less or visual field less than 20 degrees will be asked to evaluate tactile labeling product for efficacy in drug identity and dosing definition.
intervention type: Device
intervention name: Tactile Labels for Drug identity and dose frequency
description: The tactile labeling proposed in this protocol is rigid labeling. A ring-clip has an inner diameter of 12.5cm, an outer diameter of 16 cm, and a height of 1.5 cm. The ring is cut at 2 cm to form a semi-circle allowing it to be clipped onto the bottleneck. The ring clip fits most if not all prescription eye drop bottles. The individual protrusions with shapes at the end can be cut off by the pharmacist to match the frequency of administration prescribed.
arm group label: Phase I- Visually Obscured Healthy Subjects
arm group label: Phase II- Low Vision Over 50 years of age
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Praveena Gupta, O.D., Ph.D.
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vision, Low
sharing ipd: No
ipd description: Individual's data will not be shared in an identifiable format.