Clinical Trial: Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 P

Brief Summary:

A randomized, double blind, phase II multicenter trial whith the objetive 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
  • Moxifloxaci

    Detailed Summary:

    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.


    Sponsor: Laboratorios Sophia S.A de C.V.

    Current Primary Outcome:

    • Change from Baseline Bacterial culture [ Time Frame: Bacterial culture evaluation at visit 1 (day 1) versus final visit (day 8) ]

      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.

    • Change from Baseline visual capacity [ Time Frame: The presence of visual capacity at baseline (day 1) versus final visit (day 8) ]
      Visual capacity: dependent variable, discrete quantitative, measurement Snellen fraction, It will be determined as safe if there is not a reduction in 1 line in the Snellen chart.
    • Number of adverse events [ Time Frame: Number of adverse events reporting throughout the study period (day 1-7) ]
      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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change from Baseline of secretion [ Time Frame: The clinical efficacy will be evaluated by the persistence or cessation of the secretion at baseline (day 1) versus the final visit (day 8) ]
      Secretion: qualitative ordinal variable, with absent or present measurement scale.
    • Change from Baseline of conjunctival hyperemia [ Time Frame: The clinical efficacy will be evaluated by the persistence or cessation of the conjunctival hyperemia at baseline (day 1) versus the final visit (day 8) ]
      Conjunctival hyperemia: qualitative ordinal variable, with measurement scale absent, mild, moderate and severe.
    • Change from Baseline of chemosis [ Time Frame: The clinical efficacy will be evaluated by the persistence or cessation of the chemosis at baseline (day 1) versus the final visit (day 8) ]
      Chemosis: qualitative ordinal variable, measurement scale absent or present
    • Change from Baseline of eyelid edema [ Time Frame: The clinical efficacy will be evaluated by the persistence or cessation of the eyelid edema at baseline (day 1) versus the final visit (day 8) ]
      Eyelid edema: qualitative ordinal variable, measurement scale absent or present.
    • Change from Baseline of corneal epithelial defects [ Time Frame: The clinical efficacy will be evaluated by the persistence or cessation of corneal epithelial defects at baseline (day 1) versus the final visit (day 8) ]
      Corneal epithelial defects: qualitative ordinal variable, measurement scale percentage of affected area.


    Original Secondary Outcome: Same as current

    Information By: Laboratorios Sophia S.A de C.V.

    Dates:
    Date Received: November 17, 2016
    Date Started: March 2015
    Date Completion:
    Last Updated: May 17, 2017
    Last Verified: May 2017