<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/NCT03831984</url>
  </required_header>
  <id_info>
    <org_study_id>MAguilarSierra</org_study_id>
    <nct_id>NCT03831984</nct_id>
  </id_info>
  <brief_title>Topical Bromfenac for Intraoperative Miosis and Pain Reduction</brief_title>
  <official_title>Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de La Luz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de La Luz</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative&#xD;
      miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective cross-sectional randomized clinical study included 60 patients with senile&#xD;
      cataract in the absence of significant ocular comorbidity. The patients received 0.09%&#xD;
      bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil&#xD;
      diameter was measured at the initiation and finalization of femtosecond laser-assisted&#xD;
      cataract surgery and pain quantification was assessed by analogous pain scale at one day&#xD;
      follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intraoperative miosis</measure>
    <time_frame>2 days</time_frame>
    <description>Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of reduction of postoperative pain using a visual analogue scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>0,09% Bromfenac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical 0,09% Bromfenac twice daily 3 days before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0,1% sodium hyaluronate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Topical 0,1% sodium hyaluronate twice daily 3 days before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0,09% Bromfenac</intervention_name>
    <description>topical 0,09% Bromfenac, one drop twice daily 3 days before surgery</description>
    <arm_group_label>0,09% Bromfenac</arm_group_label>
    <other_name>Zebesten</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0,1% sodium hyaluronate</intervention_name>
    <description>topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery</description>
    <arm_group_label>0,1% sodium hyaluronate</arm_group_label>
    <other_name>Hyabak</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  Subjects 18 years or older&#xD;
&#xD;
          -  Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract&#xD;
             surgery with posterior chamber (PC) IOL implantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of corneal abnormalities&#xD;
&#xD;
          -  History of intraocular surgery&#xD;
&#xD;
          -  History of ocular or systematic diseases (glaucoma, diabetes, uveitis&#xD;
&#xD;
          -  Regular, systemic use of steroid or NSAIDs during the previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARIA AGUILAR SIERRA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FELLOWSHIP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maria Camila Aguilar Sierra</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>06030</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de La Luz</investigator_affiliation>
    <investigator_full_name>Maria Camila Aguilar Sierra</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Phacoemulsification</keyword>
  <keyword>femtosecond laser</keyword>
  <keyword>bromfenac</keyword>
  <keyword>NSAID</keyword>
  <keyword>pupil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromfenac</mesh_term>
    <mesh_term>Hyaluronic Acid</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/NCT03831984
org study id: MAguilarSierra
nct id: NCT03831984
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative
      miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.
This prospective cross-sectional randomized clinical study included 60 patients with senile
      cataract in the absence of significant ocular comorbidity. The patients received 0.09%
      bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil
      diameter was measured at the initiation and finalization of femtosecond laser-assisted
      cataract surgery and pain quantification was assessed by analogous pain scale at one day
      follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: intraoperative miosis
time frame: 2 days
description: Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
measure: postoperative pain
time frame: 1 day
description: Evaluation of reduction of postoperative pain using a visual analogue scale
arm group label: 0,09% Bromfenac
arm group type: Active Comparator
description: Topical 0,09% Bromfenac twice daily 3 days before surgery
arm group label: 0,1% sodium hyaluronate
arm group type: Placebo Comparator
description: Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
intervention type: Drug
intervention name: 0,09% Bromfenac
description: topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
arm group label: 0,09% Bromfenac
other name: Zebesten
intervention type: Drug
intervention name: 0,1% sodium hyaluronate
description: topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery
arm group label: 0,1% sodium hyaluronate
other name: Hyabak
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: MARIA AGUILAR SIERRA, MD
role: Principal Investigator
affiliation: FELLOWSHIP
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital de La Luz
investigator full name: Maria Camila Aguilar Sierra
investigator title: MD
mesh term: Cataract
mesh term: Bromfenac
mesh term: Hyaluronic Acid
sharing ipd: No