<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/NCT04437732</url>
  </required_header>
  <id_info>
    <org_study_id>LEN-002</org_study_id>
    <nct_id>NCT04437732</nct_id>
  </id_info>
  <brief_title>Apioc Presbyopic Contact Lens</brief_title>
  <official_title>30 Day Trial Fitting of a New Bifocal Contact Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lentechs, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lentechs, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way&#xD;
      you wear your current contact lenses for approximately one month (no more than 35 days).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved&#xD;
      by the U.S. Food and Drug Administration (FDA), although the contact lens material, called&#xD;
      Definitive 74, is already approved and marketed for contact lenses that are similar to&#xD;
      Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact&#xD;
      lens the way they wear their current contact lenses for approximately one month (no more than&#xD;
      35 days).&#xD;
&#xD;
      Participation in this study will include a minimum of four study visits. The first will last&#xD;
      up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45&#xD;
      minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be&#xD;
      fitting properly at the second visit, then another lens will be ordered for participants and&#xD;
      they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects&#xD;
      will participate in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 9, 2021</primary_completion_date>
  <phase>N/A</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>30 days</time_frame>
    <description>LogMAR visual acuity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comfort</measure>
    <time_frame>30 days</time_frame>
    <description>Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Presbyopia</condition>
  <condition>Refractive Errors</condition>
  <arm_group>
    <arm_group_label>Apioc Lens</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All subjects will wear either the Apioc-P or Apioc-PT contact lens design</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apioc-P and Apioc-PT Contact Lens Design</intervention_name>
    <description>Novel soft contact lens design</description>
    <arm_group_label>Apioc Lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject must provide written informed consent.&#xD;
&#xD;
          2. The subject must appear willing and able to adhere to the instructions set forth in&#xD;
             this protocol.&#xD;
&#xD;
          3. At least 40 years of age and no more than 70 years of age.&#xD;
&#xD;
          4. ≤ 4.00 D of corneal astigmatism.&#xD;
&#xD;
          5. ≤ 4.00 D of refractive astigmatism.&#xD;
&#xD;
          6. Refractive error range +20.00 DS to -20.00 DS&#xD;
&#xD;
          7. Keratometry readings within 40 to 50D.&#xD;
&#xD;
          8. Clear, healthy corneas with no irregular astigmatism.&#xD;
&#xD;
          9. Normal, healthy conjunctiva in both eyes.&#xD;
&#xD;
         10. Free of active ocular disease. Refractive error and presbyopia are permitted.&#xD;
&#xD;
         11. Be a current or former (within the last 12 months) contact lens wearer.&#xD;
&#xD;
         12. Best-corrected near and distance visual acuity better than or equal to 20/25.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Irregular corneal astigmatism.&#xD;
&#xD;
          2. Corneal scarring unless off line-of-site and well healed.&#xD;
&#xD;
          3. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would&#xD;
             interfere with soft contact lens wear.&#xD;
&#xD;
          4. Recent use of any ocular pharmaceutical treatments, including daily artificial tears,&#xD;
             in the two weeks prior to the examination. Use of artificial tears less than 3 times&#xD;
             per week is permitted.&#xD;
&#xD;
          5. Systemic disease that would interfere with contact lens wear.&#xD;
&#xD;
          6. Currently pregnant or lactating (by self-report).&#xD;
&#xD;
          7. History of strabismus or eye movement disorder, including exophoria at near that is 4D&#xD;
             or greater than at far, and a receded near point of convergence break that is 6 cm or&#xD;
             greater.&#xD;
&#xD;
          8. Active allergies that may inhibit contact lens wear.&#xD;
&#xD;
          9. Upper eyelid margin at or above the superior limbus.&#xD;
&#xD;
         10. History of ocular or lid surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas G Quinn, OD, MS, FAAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drs. Quinn, Foster &amp; Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason R Miller, OD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eyecare Professionals of Powell</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quinn Foster &amp; Associates</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EyeCare Professionals of Powell</name>
      <address>
        <city>Powell</city>
        <state>Ohio</state>
        <zip>43065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contact lens</keyword>
  <keyword>soft contact lens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
    <mesh_term>Refractive Errors</mesh_term>
  </condition_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/NCT04437732
org study id: LEN-002
nct id: NCT04437732
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way
      you wear your current contact lenses for approximately one month (no more than 35 days).
Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved
      by the U.S. Food and Drug Administration (FDA), although the contact lens material, called
      Definitive 74, is already approved and marketed for contact lenses that are similar to
      Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact
      lens the way they wear their current contact lenses for approximately one month (no more than
      35 days).

      Participation in this study will include a minimum of four study visits. The first will last
      up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45
      minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be
      fitting properly at the second visit, then another lens will be ordered for participants and
      they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects
      will participate in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Visual Acuity
time frame: 30 days
description: LogMAR visual acuity
measure: Comfort
time frame: 30 days
description: Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).
arm group label: Apioc Lens
arm group type: Other
description: All subjects will wear either the Apioc-P or Apioc-PT contact lens design
intervention type: Device
intervention name: Apioc-P and Apioc-PT Contact Lens Design
description: Novel soft contact lens design
arm group label: Apioc Lens
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas G Quinn, OD, MS, FAAO
role: Principal Investigator
affiliation: Drs. Quinn, Foster & Associates
last name: Jason R Miller, OD, MBA
role: Principal Investigator
affiliation: Eyecare Professionals of Powell
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Refractive Errors
sharing ipd: No