<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/NCT02214797</url>
  </required_header>
  <id_info>
    <org_study_id>CRTC2013-02</org_study_id>
    <secondary_id>ACTRN12614000011684</secondary_id>
    <nct_id>NCT02214797</nct_id>
  </id_info>
  <brief_title>Dispensing Study to Assess Visual Performance of Prototype Contact Lenses</brief_title>
  <official_title>Dispensing Study to Assess Visual Performance of Prototype Contact Lenses</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 visual performance of prototype soft contact lens designs&#xD;
      compared to commercially available contact lenses over one-week of lens wear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where&#xD;
      participants will wear prototype (test) and commercial (control) lenses bilaterally.&#xD;
      Participants will be stratified based on their refractive error into either presbyopic or&#xD;
      non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up&#xD;
      to 4 test lens designs will be assessed against the control/s in each parallel arm in a&#xD;
      randomized cross over fashion, with a minimum 2 day washout period between the lens types.&#xD;
      Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an&#xD;
      evaluation visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual performance over 1-week lens wear</measure>
    <time_frame>after about 20 minutes of lens wear and after about 1 week of lens wear</time_frame>
    <description>Visual Acuity Visual acuity will be recorded on an interval scale. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Visual acuity will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens types will be determined at each time point and over time for each lens type. Visual acuity will be analysed using linear mixed model with subject random intercepts and / or paired t-test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective response over 1-week of lens wear</measure>
    <time_frame>After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear</time_frame>
    <description>Subjective ratings Questionnaire Subjective ratings will be recorded on a scale of 1 to 10 on steps of 1. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Subjective ratings will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens type will be determined at each time point and over time for each lens type. Subjective ratings will be analysed using linear mixed model with subject random intercepts and / or paired t-test.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Presbyopia</condition>
  <condition>Refractive Error</condition>
  <arm_group>
    <arm_group_label>Presbyopic group - Low Add</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>40 years and over Add of less than +1.50D&#xD;
Control lens : Lotrafilcon B and Senofilcon A&#xD;
Test lens: Etafilcon A&#xD;
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion. Each lenses will be worn for a week with a minimum 2 day washout period between the lens types. Each lens will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presbyopic group - Med Add</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>40 years and over Add of +1.50D to +1.75D&#xD;
Control lens : Lotrafilcon B and Senofilcon A&#xD;
Test lens: Etafilcon A&#xD;
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presbyopic group - High Add</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>40 years and over Add of +2.00D to +2.50D&#xD;
Control lens : Lotrafilcon B and Senofilcon A&#xD;
Test lens: Etafilcon A&#xD;
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-presbyopic group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>18 to 39 years old No Add&#xD;
Control lens : Lotrafilcon B and Etafilcon A&#xD;
Test lens: Etafilcon A&#xD;
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Etafilcon A, Lotrafilcon B , Senofilcon A</intervention_name>
    <arm_group_label>Non-presbyopic group</arm_group_label>
    <arm_group_label>Presbyopic group - High Add</arm_group_label>
    <arm_group_label>Presbyopic group - Low Add</arm_group_label>
    <arm_group_label>Presbyopic group - Med Add</arm_group_label>
    <other_name>Control lenses</other_name>
    <other_name>Non-presbyopic group</other_name>
    <other_name>Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist</other_name>
    <other_name>Lens material: Lotrafilcon B , Etafilcon A</other_name>
    <other_name>Presbyopic group</other_name>
    <other_name>Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia</other_name>
    <other_name>Lens material Lotrafilcon B, Senofilcon A</other_name>
    <other_name>Test lens</other_name>
    <other_name>Brand name: Iteration X</other_name>
    <other_name>Lens material: Etafilcon A</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 18 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 in each eye with contact lenses&#xD;
&#xD;
          -  Be willing to not wear contact lenses for a minimum of 2 days before each stage of the&#xD;
             clinical trial (after informed consent)&#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 NB: Systemic antihistamines are allowed on&#xD;
             an &quot;as needed basis&quot;, provided they are not used prophylactically during the trial and&#xD;
             at least 24 hours before the clinical trial product is used&#xD;
&#xD;
          -  Eye surgery within 12 weeks immediately prior to enrolment for this trial.&#xD;
&#xD;
          -  Previous corneal refractive surgery&#xD;
&#xD;
          -  Contraindications to contact lens wear&#xD;
&#xD;
          -  Known allergy or intolerance to ingredients in any of the clinical trial products&#xD;
&#xD;
        The Investigator may, at his/her discretion, exclude anyone who they believe may not be&#xD;
        able to fulfil the clinical trial requirements or it is believed to be in the participant's&#xD;
        best interests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</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 Institue, 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>Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x.</citation>
    <PMID>12477016</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>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>June 23, 2015</last_update_submitted>
  <last_update_submitted_qc>June 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Presbyopia</keyword>
  <keyword>Refractive Error</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/NCT02214797
org study id: CRTC2013-02
secondary id: ACTRN12614000011684
nct id: NCT02214797
lead sponsor: 
has dmc: No
The aim of this study is to assess visual performance of prototype soft contact lens designs
      compared to commercially available contact lenses over one-week of lens wear.
Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where
      participants will wear prototype (test) and commercial (control) lenses bilaterally.
      Participants will be stratified based on their refractive error into either presbyopic or
      non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up
      to 4 test lens designs will be assessed against the control/s in each parallel arm in a
      randomized cross over fashion, with a minimum 2 day washout period between the lens types.
      Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an
      evaluation visit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in visual performance over 1-week lens wear
time frame: after about 20 minutes of lens wear and after about 1 week of lens wear
description: Visual Acuity Visual acuity will be recorded on an interval scale. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Visual acuity will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens types will be determined at each time point and over time for each lens type. Visual acuity will be analysed using linear mixed model with subject random intercepts and / or paired t-test.
measure: Change in subjective response over 1-week of lens wear
time frame: After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear
description: Subjective ratings Questionnaire Subjective ratings will be recorded on a scale of 1 to 10 on steps of 1. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Subjective ratings will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens type will be determined at each time point and over time for each lens type. Subjective ratings will be analysed using linear mixed model with subject random intercepts and / or paired t-test.
arm group label: Presbyopic group - Low Add
arm group type: Other
description: 40 years and over Add of less than +1.50D
Control lens : Lotrafilcon B and Senofilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion. Each lenses will be worn for a week with a minimum 2 day washout period between the lens types. Each lens will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.
arm group label: Presbyopic group - Med Add
arm group type: Other
description: 40 years and over Add of +1.50D to +1.75D
Control lens : Lotrafilcon B and Senofilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.
arm group label: Presbyopic group - High Add
arm group type: Other
description: 40 years and over Add of +2.00D to +2.50D
Control lens : Lotrafilcon B and Senofilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.
arm group label: Non-presbyopic group
arm group type: Other
description: 18 to 39 years old No Add
Control lens : Lotrafilcon B and Etafilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.
intervention type: Device
intervention name: Etafilcon A, Lotrafilcon B , Senofilcon A
arm group label: Non-presbyopic group
arm group label: Presbyopic group - High Add
arm group label: Presbyopic group - Low Add
arm group label: Presbyopic group - Med Add
other name: Control lenses
other name: Non-presbyopic group
other name: Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist
other name: Lens material: Lotrafilcon B , Etafilcon A
other name: Presbyopic group
other name: Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia
other name: Lens material Lotrafilcon B, Senofilcon A
other name: Test lens
other name: Brand name: Iteration X
other name: Lens material: Etafilcon A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiyoon Chung, BOptom
role: Principal Investigator
affiliation: Brien Holden Vision Institute
facility: 
country: Australia
citation: Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x.
PMID: 12477016
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
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Refractive Errors