<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/NCT02980523</url>
  </required_header>
  <id_info>
    <org_study_id>SOPH157-0114/II</org_study_id>
    <nct_id>NCT02980523</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)</brief_title>
  <acronym>Pazufloxacin</acronym>
  <official_title>A Randomized, Double Blind, Phase II Multicenter Trial to Evaluate the Safety and Efficacy of PRO-157 Ophthalmic Solution in Three Different Dosing Regimen Versus Moxifloxacin Versus Gatifloxacin in Patients With Bacterial Conjunctivitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratorios Sophia S.A de C.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratorios Sophia S.A de C.V.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double blind, phase II multicenter trial with the objective of assess the&#xD;
      safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens,&#xD;
      versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.&#xD;
&#xD;
      Number of participants: 300 eyes, 60 per group.&#xD;
&#xD;
      Criteria for evaluation:&#xD;
&#xD;
      Measurements of effectiveness: Main efficacy criterion It will be determined as effective if&#xD;
      there is a reduction in number or species of bacterial flora by comparing the basal culture&#xD;
      against the final culture among the five different patient groups.&#xD;
&#xD;
      Reduction or absence of infection with the clinical evaluation through signs and symptoms.&#xD;
&#xD;
      Safety Measurements: it will be determined by visual acuity and adverse events Patients&#xD;
      recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken&#xD;
      into account at the time of baseline, however the study medication and procedures will be&#xD;
      applied and performed in both eyes to protect the healthy eye.&#xD;
&#xD;
      The study is divided into the following evaluation periods:&#xD;
&#xD;
      Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23)&#xD;
      for the evaluation of adverse events.&#xD;
&#xD;
      Subjects will be allocated to any of the following regimen dosages:&#xD;
&#xD;
        -  PRO-157 1 drop 2 times daily&#xD;
&#xD;
        -  PRO-157 1 drop 3 times daily&#xD;
&#xD;
        -  PRO-157 1 drop 4 times daily&#xD;
&#xD;
        -  Moxifloxacin 1 drop 3 times daily&#xD;
&#xD;
        -  Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An&#xD;
           artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes&#xD;
           before instillation of study drug, during study period.&#xD;
&#xD;
      Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in&#xD;
      which each of the variables is described, the ITT population will be constituted by all&#xD;
      subjects recruited who have received at least one dose of the study, the PP population will&#xD;
      be the subset of ITT composed of all subjects without any major deviation from the protocol&#xD;
      and the bivariate analysis will be performed in this group.&#xD;
&#xD;
      Continuous quantitative variables are expressed and presented by measures of central tendency&#xD;
      and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal&#xD;
      variables are presented by means of frequencies and proportions. The level of significance&#xD;
      was an alpha of 0.05 or less.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the&#xD;
      document can not be translated into the English language.&#xD;
&#xD;
      PRO-157, the acronym is part of an internal code used to record formulations or research&#xD;
      projects and the numbers indicate consecutive of the molecule under study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline Bacterial Culture</measure>
    <time_frame>up to one week</time_frame>
    <description>Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species.&#xD;
The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>during the intervention period for 7 days, and 15 days after the final visit</time_frame>
    <description>Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cases Frequency of Ocular Secretion</measure>
    <time_frame>Up to one week.</time_frame>
    <description>Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cases of Conjunctival Hyperemia</measure>
    <time_frame>up to one week</time_frame>
    <description>Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemosis Frequency</measure>
    <time_frame>up to one week</time_frame>
    <description>Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyelid Edema Frequency</measure>
    <time_frame>Up to one week</time_frame>
    <description>Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).&#xD;
The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Corneal Epithelial Defects</measure>
    <time_frame>Up to one week</time_frame>
    <description>Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.&#xD;
The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Bacterial Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>PRO-157 BID (2 times per day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRO-157 TID (3 times per day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRO-157 QID (4 times per day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin (Vigamox®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gatifloxacin (Zymar®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRO-157</intervention_name>
    <description>PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
    <arm_group_label>PRO-157 BID (2 times per day)</arm_group_label>
    <arm_group_label>PRO-157 QID (4 times per day)</arm_group_label>
    <arm_group_label>PRO-157 TID (3 times per day)</arm_group_label>
    <other_name>Pazufloxacin 0.06%, ophthalmic solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vigamox</intervention_name>
    <description>Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution</description>
    <arm_group_label>Moxifloxacin (Vigamox®)</arm_group_label>
    <other_name>Moxifloxacin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zymar®</intervention_name>
    <description>Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution</description>
    <arm_group_label>Gatifloxacin (Zymar®)</arm_group_label>
    <other_name>Gatifloxacin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lagricel Ofteno®</intervention_name>
    <description>Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
    <arm_group_label>Gatifloxacin (Zymar®)</arm_group_label>
    <arm_group_label>Moxifloxacin (Vigamox®)</arm_group_label>
    <arm_group_label>PRO-157 BID (2 times per day)</arm_group_label>
    <arm_group_label>PRO-157 QID (4 times per day)</arm_group_label>
    <arm_group_label>PRO-157 TID (3 times per day)</arm_group_label>
    <other_name>Sodium hyaluronate 0.4%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obtained from physician office visit.&#xD;
&#xD;
          -  Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).&#xD;
&#xD;
          -  Informed Consent signed and dated (consent of the parents for minor patients).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absence of written informed consent.&#xD;
&#xD;
          -  Women of childbearing age, without contraceptive use (oral contraceptive pill,&#xD;
             contraceptive intrauterine device, contraceptive implant, patch or condom).&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Subjects that could not be evaluated partially or totally according to the protocol.&#xD;
&#xD;
          -  Subjects with topical, systemic or intravenous medication with any type of antibiotic&#xD;
             on the day of the baseline visit.&#xD;
&#xD;
          -  Subjects with topical, systemic or intravenous medication with any type of medication&#xD;
             that interferes decisively with the results of the study.&#xD;
&#xD;
          -  Subjects with a hypersensitivity history to any component or analogues of the&#xD;
             formulation product.&#xD;
&#xD;
          -  Positive drug addiction (smoking, alcoholism, marijuana).&#xD;
&#xD;
          -  Subjects with a history of participation in any clinical study in the last 40 days&#xD;
             prior to their evaluation.&#xD;
&#xD;
          -  incapacity to give informed consent owing to mental disorder or legal condition.&#xD;
&#xD;
          -  Any major anomaly detected during the clinical examination, tests that could interfere&#xD;
             with the performance of the study or with the efficacy and safety evaluations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leopoldo Baiza, MD</last_name>
    <role>Study Director</role>
    <affiliation>Laboratorios Sophia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unidad Medica &quot;Grupo Pediátrico&quot;</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44690</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>June 21, 2017</results_first_submitted>
  <results_first_submitted_qc>September 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2019</results_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</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>Conjunctivitis, Bacterial</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <mesh_term>Gatifloxacin</mesh_term>
    <mesh_term>Pazufloxacin</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT02980523/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PRO-157 BID (2 Times Per Day)</title>
          <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="P2">
          <title>PRO-157 TID (3 Times Per Day)</title>
          <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="P3">
          <title>PRO-157 QID (4 Times Per Day)</title>
          <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="P4">
          <title>Moxifloxacin (Vigamox®)</title>
          <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="P5">
          <title>Gatifloxacin (Zymar®)</title>
          <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="30"/>
                <participants group_id="P5" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded from analysis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not receive intervention</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PRO-157 BID</title>
          <description>One drop twice a day for 7 days (PRO-157=pazufloxacin 0.6%)</description>
        </group>
        <group group_id="B2">
          <title>PRO-157 TID</title>
          <description>One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)</description>
        </group>
        <group group_id="B3">
          <title>PRO-157 QID</title>
          <description>One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)</description>
        </group>
        <group group_id="B4">
          <title>Moxifloxacine</title>
          <description>One drop four times a day for 7 days Moxifloxacin 0.5% (Vigamox®).</description>
        </group>
        <group group_id="B5">
          <title>Gatifloxacine</title>
          <description>One drop four times a day for 7 days Gatifloxacin 0.3% (Zymar®).</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="21"/>
            <count group_id="B5" value="20"/>
            <count group_id="B6" value="111"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="48"/>
            <count group_id="B4" value="42"/>
            <count group_id="B5" value="40"/>
            <count group_id="B6" value="222"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.1" spread="27.9"/>
                    <measurement group_id="B2" value="37.2" spread="21.3"/>
                    <measurement group_id="B3" value="43.3" spread="25.7"/>
                    <measurement group_id="B4" value="39.9" spread="26.9"/>
                    <measurement group_id="B5" value="43.4" spread="29.5"/>
                    <measurement group_id="B6" value="40.8" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <title>Mexicans</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>others</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Bacterial Culture</title>
        <description>Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species.&#xD;
The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.</description>
        <time_frame>up to one week</time_frame>
        <population>Treatment analysis, a culture was performed per eye</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Bacterial Culture</title>
          <description>Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species.&#xD;
The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.</description>
          <population>Treatment analysis, a culture was performed per eye</population>
          <units>cultures</units>
          <param>Number</param>
          <units_analyzed>cultures</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>cultures</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>basal cultures positives</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>final cultures negatives</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="28"/>
                    <measurement group_id="O5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events</title>
        <description>Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.</description>
        <time_frame>during the intervention period for 7 days, and 15 days after the final visit</time_frame>
        <population>Treatment analysis</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.</description>
          <population>Treatment analysis</population>
          <units>events</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.372</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cases Frequency of Ocular Secretion</title>
        <description>Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
        <time_frame>Up to one week.</time_frame>
        <population>treatment analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Cases Frequency of Ocular Secretion</title>
          <description>Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
          <population>treatment analysis.</population>
          <units>secretion cases reported</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.341</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cases of Conjunctival Hyperemia</title>
        <description>Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
        <time_frame>up to one week</time_frame>
        <population>Treatment analysis</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cases of Conjunctival Hyperemia</title>
          <description>Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
          <population>Treatment analysis</population>
          <units>hyperemia cases reported</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.001</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemosis Frequency</title>
        <description>Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
        <time_frame>up to one week</time_frame>
        <population>Treatment analysis</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Chemosis Frequency</title>
          <description>Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
          <population>Treatment analysis</population>
          <units>chemosis cases reported</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.003</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eyelid Edema Frequency</title>
        <description>Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).&#xD;
The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
        <time_frame>Up to one week</time_frame>
        <population>Treatment analysis</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Eyelid Edema Frequency</title>
          <description>Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).&#xD;
The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
          <population>Treatment analysis</population>
          <units>eyelid edema cases reported</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.216</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Corneal Epithelial Defects</title>
        <description>Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.&#xD;
The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
        <time_frame>Up to one week</time_frame>
        <population>Treatment analysis</population>
        <group_list>
          <group group_id="O1">
            <title>PRO-157 BID (2 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O2">
            <title>PRO-157 TID (3 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O3">
            <title>PRO-157 QID (4 Times Per Day)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O4">
            <title>Moxifloxacin (Vigamox®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
          <group group_id="O5">
            <title>Gatifloxacin (Zymar®)</title>
            <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Corneal Epithelial Defects</title>
          <description>Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.&#xD;
The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.</description>
          <population>Treatment analysis</population>
          <units>Corneal defects cases reported</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="42"/>
                <count group_id="O5" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.</non_inferiority_desc>
            <p_value>0.829</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored during the intervention period for 8 days, and a follow-up call was made 15 days after the final visit.</time_frame>
      <desc>Adverse events were recorded according to the patient's scheduled or unscheduled visits, and were given a diary in which they could make annotations of their symptoms, the investigator reviewed these symptoms and reported on them The format of adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>PRO-157 BID (2 Times Per Day)</title>
          <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days&#xD;
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="E2">
          <title>PRO-157 TID (3 Times Per Day)</title>
          <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="E3">
          <title>PRO-157 QID (4 Times Per Day)</title>
          <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)&#xD;
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="E4">
          <title>Moxifloxacin (Vigamox®)</title>
          <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)&#xD;
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
        <group group_id="E5">
          <title>Gatifloxacin (Zymar®)</title>
          <description>60 eyes will be evaluated with the following therapeutic regimen:&#xD;
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.&#xD;
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)&#xD;
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution&#xD;
Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>ischemic optic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>urinary tract infection (ITU)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyelid ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hordeolum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>eye pain</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Numular keratitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Irritant conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Preseptal cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>stomach flu</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>stomachache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lack of effectiveness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Systemic hypertension</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI (s) can not make use of the partial or total information of this investigation, due to the clauses contained in the agreement of confidentiality of the study.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>In the present study the efficacy of pazufloxacin at different doses has not been demonstrated. In addition, the minimum inhibitory dose for ophthalmic administration is not established. Cultures could also not be determined in all study subjects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical pharmacologist</name_or_title>
      <organization>Laboratorios Sophia</organization>
      <phone>+52 (33) 3001 4200 ext 1259</phone>
      <email>ricardo.llamas@sophia.com.mx</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02980523
org study id: SOPH157-0114/II
nct id: NCT02980523
lead sponsor: 
has dmc: Yes
A randomized, double blind, phase II multicenter trial with the objective of assess the
      safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens,
      versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.

      Number of participants: 300 eyes, 60 per group.

      Criteria for evaluation:

      Measurements of effectiveness: Main efficacy criterion It will be determined as effective if
      there is a reduction in number or species of bacterial flora by comparing the basal culture
      against the final culture among the five different patient groups.

      Reduction or absence of infection with the clinical evaluation through signs and symptoms.

      Safety Measurements: it will be determined by visual acuity and adverse events Patients
      recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken
      into account at the time of baseline, however the study medication and procedures will be
      applied and performed in both eyes to protect the healthy eye.

      The study is divided into the following evaluation periods:

      Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23)
      for the evaluation of adverse events.

      Subjects will be allocated to any of the following regimen dosages:

        -  PRO-157 1 drop 2 times daily

        -  PRO-157 1 drop 3 times daily

        -  PRO-157 1 drop 4 times daily

        -  Moxifloxacin 1 drop 3 times daily

        -  Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An
           artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes
           before instillation of study drug, during study period.

      Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in
      which each of the variables is described, the ITT population will be constituted by all
      subjects recruited who have received at least one dose of the study, the PP population will
      be the subset of ITT composed of all subjects without any major deviation from the protocol
      and the bivariate analysis will be performed in this group.

      Continuous quantitative variables are expressed and presented by measures of central tendency
      and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal
      variables are presented by means of frequencies and proportions. The level of significance
      was an alpha of 0.05 or less.
Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the
      document can not be translated into the English language.

      PRO-157, the acronym is part of an internal code used to record formulations or research
      projects and the numbers indicate consecutive of the molecule under study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline Bacterial Culture
time frame: up to one week
description: Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species.
The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.
measure: Adverse Events
time frame: during the intervention period for 7 days, and 15 days after the final visit
description: Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.
measure: Cases Frequency of Ocular Secretion
time frame: Up to one week.
description: Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
measure: Number of Cases of Conjunctival Hyperemia
time frame: up to one week
description: Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
measure: Chemosis Frequency
time frame: up to one week
description: Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
measure: Eyelid Edema Frequency
time frame: Up to one week
description: Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).
The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
measure: Frequency of Corneal Epithelial Defects
time frame: Up to one week
description: Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.
The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
arm group label: PRO-157 BID (2 times per day)
arm group type: Experimental
description: 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
arm group label: PRO-157 TID (3 times per day)
arm group type: Experimental
description: 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
arm group label: PRO-157 QID (4 times per day)
arm group type: Experimental
description: 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
arm group label: Moxifloxacin (Vigamox®)
arm group type: Active Comparator
description: 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)
arm group label: Gatifloxacin (Zymar®)
arm group type: Active Comparator
description: 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)
intervention type: Drug
intervention name: PRO-157
description: PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
arm group label: PRO-157 BID (2 times per day)
arm group label: PRO-157 QID (4 times per day)
arm group label: PRO-157 TID (3 times per day)
other name: Pazufloxacin 0.06%, ophthalmic solution
intervention type: Drug
intervention name: Vigamox
description: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
arm group label: Moxifloxacin (Vigamox®)
other name: Moxifloxacin
intervention type: Drug
intervention name: Zymar®
description: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
arm group label: Gatifloxacin (Zymar®)
other name: Gatifloxacin
intervention type: Drug
intervention name: Lagricel Ofteno®
description: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
arm group label: Gatifloxacin (Zymar®)
arm group label: Moxifloxacin (Vigamox®)
arm group label: PRO-157 BID (2 times per day)
arm group label: PRO-157 QID (4 times per day)
arm group label: PRO-157 TID (3 times per day)
other name: Sodium hyaluronate 0.4%
criteria: 
gender: All
minimum age: 1 Day
maximum age: 99 Years
healthy volunteers: No
last name: Leopoldo Baiza, MD
role: Study Director
affiliation: Laboratorios Sophia
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Conjunctivitis, Bacterial
mesh term: Conjunctivitis
mesh term: Moxifloxacin
mesh term: Gatifloxacin
mesh term: Pazufloxacin
mesh term: Ophthalmic Solutions
mesh term: Hyaluronic Acid
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In the present study the efficacy of pazufloxacin at different doses has not been demonstrated. In addition, the minimum inhibitory dose for ophthalmic administration is not established. Cultures could also not be determined in all study subjects.
point of contact: 