<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/NCT02974387</url>
  </required_header>
  <id_info>
    <org_study_id>SERCCT1</org_study_id>
    <nct_id>NCT02974387</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study</brief_title>
  <official_title>Randomized, Single Blinded Controlled Trial for Evaluation of the Safety and Efficacy of Loteprednol Versus Fluorometholone After Photorefractive Keratectomy for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Salouti Eye Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr Salouti Eye Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing&#xD;
      and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy&#xD;
      (PRK) surgery.&#xD;
&#xD;
      OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral&#xD;
      (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the&#xD;
      eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months&#xD;
      Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for&#xD;
      one month, 3 x a day for one month and 2 x a day for one month Study medication will be&#xD;
      administered to the randomized eye through post op days according to mention protocol. Visit&#xD;
      Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal&#xD;
      re-epithelialization).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>April 2017</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to re-epithelialization</measure>
    <time_frame>3-7 days</time_frame>
    <description>Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to zero pain</measure>
    <time_frame>3-7 days</time_frame>
    <description>Study subject will complete a questionnaire about their comfort levels at each postoperative visit, up to an including the 3-7 days post op exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of enhancements</measure>
    <time_frame>3 months post operative</time_frame>
    <description>Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Day 1 up to day 90</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Must be PRK Candidate</condition>
  <arm_group>
    <arm_group_label>Fluorometholone(FMl)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be randomized to the eye and will receive FML in one eye.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loteprednol (Lotemax)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be randomized to the eye and will receive Lotemax in contralateral eye.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorometholone(FML)</intervention_name>
    <arm_group_label>Fluorometholone(FMl)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loteprednol (Lotemax)</intervention_name>
    <arm_group_label>Loteprednol (Lotemax)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, 18-45 yrs of age, in good general health&#xD;
&#xD;
          -  PRK candidate(Subjects willing and able to undergo bilateral PRK for the correction of&#xD;
             their myopia. )&#xD;
&#xD;
          -  Refractive error -1 to -8 diopters (spherical equivalent) at baseline&#xD;
&#xD;
          -  Females of childbearing age must have a negative pregnancy test result at baseline. A&#xD;
             female considered to be of non-childbearing potential is she is postmenopausal (no&#xD;
             menses for 12 consecutive months) or is without a uterus.&#xD;
&#xD;
          -  Ability to follow study instructions and likely to complete the entire course of the&#xD;
             study(Subjects who are able to comply with all study procedures, including wearing a&#xD;
             soft bandage contact lens in the immediate postoperative period. )&#xD;
&#xD;
          -  Written informed consent will be obtained&#xD;
&#xD;
          -  Written HIPPA authorization will be obtained&#xD;
&#xD;
          -  Subjects with MRSE &lt;6.0 D, with less than 2.0 D of astigmatism.&#xD;
&#xD;
          -  Stable prescription in both eyes as defined by &lt;0.25 D change over the preceding 2&#xD;
             years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled systemic disease you mean if someone has controlled DM or rheumatic&#xD;
             disease can be included&#xD;
&#xD;
          -  Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular&#xD;
             pathologies&#xD;
&#xD;
          -  History of serious eye disease, trauma, or previous ocular surgery&#xD;
&#xD;
          -  History of unstable myopia&#xD;
&#xD;
          -  History of herpes keratitis&#xD;
&#xD;
          -  Known allergy or hypersensitivity to the study medication&#xD;
&#xD;
          -  Anticipated wearing of contact lenses in addition to the required bandage contact lens&#xD;
             post-PRK. Patients who wear soft contact lenses should discontinue wearing them at&#xD;
             least 7 days prior to baseline visit. Patients wearing RGP or hard contact lenses&#xD;
             should discontinue wearing them at least 3 weeks prior to baseline visit.&#xD;
&#xD;
          -  Females who are pregnant, breastfeeding, or trying to conceive.&#xD;
&#xD;
          -  Keratoconus or keratoconus suspect&#xD;
&#xD;
          -  Any condition or situation which, in the investigator's opinion, may put patient at&#xD;
             significant risk or may confound the study results&#xD;
&#xD;
          -  Subjects who have a past or present disease, which as judged by the investigator may&#xD;
             affect the safety of the subject or the outcome of the study.&#xD;
&#xD;
          -  Subjects who have previously had corneal surgery.&#xD;
&#xD;
          -  Subjects with any ocular disease or corneal abnormality, including but not limited to:&#xD;
&#xD;
               -  Decreased corneal sensation / neurotrophic cornea;&#xD;
&#xD;
               -  Corneal vascularization;&#xD;
&#xD;
               -  Keratoconus;&#xD;
&#xD;
               -  Keratoconjunctivitis sicca requiring chronic treatment;&#xD;
&#xD;
               -  Lagophthalmos;&#xD;
&#xD;
               -  Blepharitis;&#xD;
&#xD;
               -  History of infectious keratitis;&#xD;
&#xD;
               -  History of glaucoma or intraocular pressure of &gt;21 mmHg or use of glaucoma&#xD;
                  medications;&#xD;
&#xD;
               -  Significant dry eye disease that requires regular topical treatment;&#xD;
&#xD;
               -  Corneal thickness &lt;480 µm at the thinnest point, and&#xD;
&#xD;
               -  Posterior elevation &gt;40 micron.&#xD;
&#xD;
               -  Subjects who require any topical ophthalmic medication other than the pre- and&#xD;
                  postoperative regimen defined in the study protocol.&#xD;
&#xD;
               -  Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine,&#xD;
                  scopolamine, or medications or agents that can cause dry eye.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Payam Peymani, Pharm.D, PhD</last_name>
    <email>peymani.payam@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammadreza Razeghinejad, M.D., Ophthalmologist</last_name>
    <email>razeghinejad@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</mesh_term>
    <mesh_term>Fluorometholone</mesh_term>
  </intervention_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/NCT02974387
org study id: SERCCT1
nct id: NCT02974387
lead sponsor: 
collaborator: 
has dmc: Yes
STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing
      and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy
      (PRK) surgery.

      OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral
      (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the
      eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months
      Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for
      one month, 3 x a day for one month and 2 x a day for one month Study medication will be
      administered to the randomized eye through post op days according to mention protocol. Visit
      Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal
      re-epithelialization).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Time to re-epithelialization
time frame: 3-7 days
description: Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.
measure: Time to zero pain
time frame: 3-7 days
description: Study subject will complete a questionnaire about their comfort levels at each postoperative visit, up to an including the 3-7 days post op exam.
measure: Occurrence of enhancements
time frame: 3 months post operative
description: Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.
measure: Incidence of adverse events
time frame: Day 1 up to day 90
arm group label: Fluorometholone(FMl)
arm group type: Active Comparator
description: Patients will be randomized to the eye and will receive FML in one eye.
arm group label: Loteprednol (Lotemax)
arm group type: Active Comparator
description: Patients will be randomized to the eye and will receive Lotemax in contralateral eye.
intervention type: Drug
intervention name: Fluorometholone(FML)
arm group label: Fluorometholone(FMl)
intervention type: Drug
intervention name: Loteprednol (Lotemax)
arm group label: Loteprednol (Lotemax)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Payam Peymani, Pharm.D, PhD
email: peymani.payam@gmail.com
last name: Mohammadreza Razeghinejad, M.D., Ophthalmologist
email: razeghinejad@yahoo.com
responsible party type: Sponsor
mesh term: Myopia
mesh term: Loteprednol Etabonate
mesh term: Fluorometholone
sharing ipd: No