NCT02980523

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 1 Day – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Conjunctivitis

Interventions

Type	Name	Description
DRUG	PRO-157	PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
DRUG	Vigamox	Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
DRUG	Zymar®	Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
DRUG	Lagricel Ofteno®	Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-06-01
• Completion: 2017-05-01
• First posted: 2016-12-02
• Last updated: 2019-05-22
• Results posted: 2019-02-15

Locations

1 site across 1 country: Mexico