<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/NCT03245853</url>
  </required_header>
  <id_info>
    <org_study_id>20170265</org_study_id>
    <nct_id>NCT03245853</nct_id>
  </id_info>
  <brief_title>Epi-On Corneal Crosslinking for Keratoconus</brief_title>
  <official_title>Epithelium-On Corneal Collagen Crosslinking for Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Comprehensive EyeCare of Central Ohio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glaukos Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Comprehensive EyeCare of Central Ohio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epithelium-On Corneal Crosslinking for Keratoconus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a&#xD;
      candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked&#xD;
      to participate in this study and will undergo the required screening procedures to determine&#xD;
      study eligibility. Informed consent will be obtained from each subject before performance of&#xD;
      any required any required study procedures that are not part of the investigator's routine&#xD;
      examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day),&#xD;
      then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and&#xD;
      measurements of best spectacle-corrected visual acuity will be obtained and baseline and at&#xD;
      appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the&#xD;
      study will include observations at appropriate times for adverse events, clinically&#xD;
      significant findings on ophthalmic examination, and slit-lamp examination.&#xD;
&#xD;
      The primary efficacy parameter is the change from baseline over time in maximum keratometry&#xD;
      (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and&#xD;
      best corrected visual acuity (BCVA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo required screening testing. Informed consent will be obtained from each subject prior to study-oriented testing.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum keratometric change</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline keratometric maximum over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity change</measure>
    <time_frame>12 months</time_frame>
    <description>Change from baseline uncorrected distance visual acuity and best spectacle-corrected visual acuity.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Keratoconus</condition>
  <condition>Keratoconus, Unstable</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment as per protocol, there is no placebo arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Riboflavin 5'-Phosphate</intervention_name>
    <description>Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg [0.12%] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Photrexa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 to 40 years of age, having a diagnosis of keratoconus, signed written informed&#xD;
             consent, willingness and ability to comply with schedule for follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous ocular condition (other than refractive error) in the eye(s) to be treated&#xD;
             that may predispose the eye for future complications (herpes simplex/zoster, recurrent&#xD;
             corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to&#xD;
             become pregnant, or lactation during study. Corneal pachymetry &lt;350 microns at the&#xD;
             thinnest point measured by Pentacam in the eye(s) to be treated.&#xD;
&#xD;
        Nystagmus or any other condition that would prevent steady gaze. Other systemic condition&#xD;
        that in the investigator's opinion would not allow the patient to be a good candidate for&#xD;
        the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth A Beckman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Comprehensive EyeCare of Central Ohio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive EyeCare of Central Ohio</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Keratoconus</keyword>
  <keyword>Corneal Crosslinking</keyword>
  <keyword>CXL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riboflavin</mesh_term>
    <mesh_term>Flavin Mononucleotide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03245853/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03245853/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>February 3, 2022</submitted>
    <returned>February 24, 2022</returned>
  </pending_results>
  <!-- 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/NCT03245853
org study id: 20170265
nct id: NCT03245853
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Epithelium-On Corneal Crosslinking for Keratoconus.
Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a
      candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked
      to participate in this study and will undergo the required screening procedures to determine
      study eligibility. Informed consent will be obtained from each subject before performance of
      any required any required study procedures that are not part of the investigator's routine
      examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day),
      then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and
      measurements of best spectacle-corrected visual acuity will be obtained and baseline and at
      appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the
      study will include observations at appropriate times for adverse events, clinically
      significant findings on ophthalmic examination, and slit-lamp examination.

      The primary efficacy parameter is the change from baseline over time in maximum keratometry
      (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and
      best corrected visual acuity (BCVA).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo required screening testing. Informed consent will be obtained from each subject prior to study-oriented testing.
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum keratometric change
time frame: 12 months
description: Change from baseline keratometric maximum over time.
measure: Visual acuity change
time frame: 12 months
description: Change from baseline uncorrected distance visual acuity and best spectacle-corrected visual acuity.
arm group label: Treatment
arm group type: Other
description: Treatment as per protocol, there is no placebo arm.
intervention type: Drug
intervention name: Riboflavin 5'-Phosphate
description: Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg [0.12%] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.
arm group label: Treatment
other name: Photrexa
criteria: 
gender: All
minimum age: 14 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth A Beckman, M.D.
role: Principal Investigator
affiliation: Comprehensive EyeCare of Central Ohio
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratoconus
mesh term: Riboflavin
mesh term: Flavin Mononucleotide
provided document: 
provided document: 
submitted: February 3, 2022
returned: February 24, 2022