Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PRO-157; Vigamox; Zymar®; Lagricel Ofteno®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution; Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution; Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution; Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Other intervention name(s): Pazufloxacin 0.06%, ophthalmic solution; Moxifloxacin; Gatifloxacin; Sodium hyaluronate 0.4%
Intervention MeSH terms: Moxifloxacin; Gatifloxacin; Pazufloxacin; Ophthalmic Solutions; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment