<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/NCT02193555</url>
  </required_header>
  <id_info>
    <org_study_id>CRTC2014-02</org_study_id>
    <nct_id>NCT02193555</nct_id>
  </id_info>
  <brief_title>Visual Performance of Prototype Contact Lens Designs</brief_title>
  <official_title>Visual Performance of Prototype Contact Lens Designs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brien Holden Vision</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brien Holden Vision</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the visual performance of prototype soft contact lens&#xD;
      designs compared to a commercially available contact lens&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, participant-masked, randomised, stratified, crossover, bilateral wear,&#xD;
      dispensing clinical trial where participants will wear the prototype (test) and the&#xD;
      commercial (control) lens. A minimum of an overnight washout period is required between the&#xD;
      fitting /assessment visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual performance</measure>
    <time_frame>After about 20 minutes of lens wear</time_frame>
    <description>Visual acuity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective responses</measure>
    <time_frame>After about 40 minutes of lens wear</time_frame>
    <description>Subjective ratings of vision</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Presbyopia</condition>
  <condition>Refractive Error</condition>
  <arm_group>
    <arm_group_label>Non-presbyopic group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Non-presbyopic group: age ranging from 7 to 39 years&#xD;
At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.&#xD;
For each fitting visit, lenses will be fitted bilaterally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presbyopic group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Presbyopic group: age 40 and above&#xD;
At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.&#xD;
For each fitting visit, lenses will be fitted bilaterally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Etafilcon A, Senofilcon A</intervention_name>
    <description>1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).</description>
    <arm_group_label>Non-presbyopic group</arm_group_label>
    <arm_group_label>Presbyopic group</arm_group_label>
    <other_name>Control lenses</other_name>
    <other_name>Non-presbyopic group</other_name>
    <other_name>Brand name: 1-Day Acuvue® Moist®</other_name>
    <other_name>Lens material: Etafilcon A</other_name>
    <other_name>Presbyopic group</other_name>
    <other_name>Brand name: Acuvue® Oasys® for Presbyopia</other_name>
    <other_name>Lens material: Senofilcon A</other_name>
    <other_name>Test lens</other_name>
    <other_name>Brand name: Iteration X</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to read and comprehend English and give informed consent as demonstrated by&#xD;
             signing a record of informed consent.&#xD;
&#xD;
          -  Be at least 7 years old, male or female.&#xD;
&#xD;
          -  Willing to comply with the wearing and clinical trial visit schedule as directed by&#xD;
             the Investigator.&#xD;
&#xD;
          -  Have ocular health findings considered to be &quot;normal&quot; and which would not prevent the&#xD;
             participant from safely wearing contact lenses.&#xD;
&#xD;
          -  Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.&#xD;
&#xD;
          -  Be suitable and willing to wear contact lenses.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pre-existing ocular irritation, injury or condition (including infection or&#xD;
             disease) of the cornea, conjunctiva or eyelids that would preclude contact lens&#xD;
             fitting and safe wearing of contact lenses.&#xD;
&#xD;
          -  Any systemic disease that adversely affects ocular health e.g. diabetes, Graves'&#xD;
             disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis,&#xD;
             Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic&#xD;
             hypertension and arthritis do not automatically exclude prospective participants.&#xD;
&#xD;
          -  Use of or a need for concurrent category S3 and above ocular medication at enrolment&#xD;
             and/or during the clinical trial.&#xD;
&#xD;
          -  Use of or a need for any systemic medication or topical medications which may alter&#xD;
             normal ocular findings / are known to affect a participant's ocular health /&#xD;
             physiology or contact lens performance either in an adverse or beneficial manner at&#xD;
             enrolment and/or during the clinical trial.&#xD;
&#xD;
          -  Eye surgery within 12 weeks immediately prior to enrolment for this trial.&#xD;
&#xD;
        NB: Systemic antihistamines are allowed on an &quot;as needed basis&quot;, provided they are not used&#xD;
        prophylactically during the trial and at least 24 hours before the clinical trial product&#xD;
        is used.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiyoon Chung, BOptom</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brien Holden Vision Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brien Holden Vision Institute, Clinical Research Trials Center</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <reference>
    <citation>Morgan PB, Efron N. A decade of contact lens prescribing trends in the United Kingdom (1996-2005). Cont Lens Anterior Eye. 2006 May;29(2):59-68. doi: 10.1016/j.clae.2006.02.008. Epub 2006 Mar 31.</citation>
    <PMID>16580247</PMID>
  </reference>
  <reference>
    <citation>Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5.</citation>
    <PMID>18538404</PMID>
  </reference>
  <reference>
    <citation>Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.</citation>
    <PMID>21276616</PMID>
  </reference>
  <reference>
    <citation>Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.</citation>
    <PMID>22039230</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Presbyopia</keyword>
  <keyword>Refractive error correction</keyword>
  <keyword>Contact lenses</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>
  <!-- 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/NCT02193555
org study id: CRTC2014-02
nct id: NCT02193555
lead sponsor: 
has dmc: No
The aim of this study is to assess the visual performance of prototype soft contact lens
      designs compared to a commercially available contact lens
Prospective, participant-masked, randomised, stratified, crossover, bilateral wear,
      dispensing clinical trial where participants will wear the prototype (test) and the
      commercial (control) lens. A minimum of an overnight washout period is required between the
      fitting /assessment visits.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Visual performance
time frame: After about 20 minutes of lens wear
description: Visual acuity
measure: Subjective responses
time frame: After about 40 minutes of lens wear
description: Subjective ratings of vision
arm group label: Non-presbyopic group
arm group type: Other
description: Non-presbyopic group: age ranging from 7 to 39 years
At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.
For each fitting visit, lenses will be fitted bilaterally.
arm group label: Presbyopic group
arm group type: Other
description: Presbyopic group: age 40 and above
At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.
For each fitting visit, lenses will be fitted bilaterally.
intervention type: Device
intervention name: Etafilcon A, Senofilcon A
description: 1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
arm group label: Non-presbyopic group
arm group label: Presbyopic group
other name: Control lenses
other name: Non-presbyopic group
other name: Brand name: 1-Day Acuvue® Moist®
other name: Lens material: Etafilcon A
other name: Presbyopic group
other name: Brand name: Acuvue® Oasys® for Presbyopia
other name: Lens material: Senofilcon A
other name: Test lens
other name: Brand name: Iteration X
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jiyoon Chung, BOptom
role: Principal Investigator
affiliation: Brien Holden Vision Institute
facility: 
country: Australia
citation: Morgan PB, Efron N. A decade of contact lens prescribing trends in the United Kingdom (1996-2005). Cont Lens Anterior Eye. 2006 May;29(2):59-68. doi: 10.1016/j.clae.2006.02.008. Epub 2006 Mar 31.
PMID: 16580247
citation: Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5.
PMID: 18538404
citation: Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.
PMID: 21276616
citation: Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.
PMID: 22039230
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Refractive Errors