Bacterial Conjunctivitis Clinical Trial
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.
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.
;
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