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

NCT ID: NCT02980523

Last Updated: 2019-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRO-157 BID (2 times per day)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days

2. 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)

Group Type: EXPERIMENTAL

PRO-157

Intervention Type: DRUG

PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®

Intervention Type: DRUG

Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

PRO-157 TID (3 times per day)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days

2. 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)

Group Type: EXPERIMENTAL

PRO-157

Intervention Type: DRUG

PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®

Intervention Type: DRUG

Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

PRO-157 QID (4 times per day)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days

2. 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)

Group Type: EXPERIMENTAL

PRO-157

Intervention Type: DRUG

PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®

Intervention Type: DRUG

Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Moxifloxacin (Vigamox®)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.

2. 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)

Group Type: ACTIVE_COMPARATOR

Vigamox

Intervention Type: DRUG

Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®

Intervention Type: DRUG

Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Gatifloxacin (Zymar®)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.

2. 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)

Group Type: ACTIVE_COMPARATOR

Zymar®

Intervention Type: DRUG

Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®

Intervention Type: DRUG

Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Interventions

PRO-157

PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Intervention Type: DRUG

Vigamox

Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Intervention Type: DRUG

Zymar®

Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Intervention Type: DRUG

Lagricel Ofteno®

Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

Pazufloxacin 0.06%, ophthalmic solution; Moxifloxacin; Gatifloxacin; Sodium hyaluronate 0.4%

Eligibility Criteria

Inclusion Criteria

• Obtained from physician office visit.
• Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).
• Informed Consent signed and dated (consent of the parents for minor patients).

Exclusion Criteria

• absence of written informed consent.
• Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom).
• Pregnant or breastfeeding women.
• Subjects that could not be evaluated partially or totally according to the protocol.
• Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit.
• Subjects with topical, systemic or intravenous medication with any type of medication that interferes decisively with the results of the study.
• Subjects with a hypersensitivity history to any component or analogues of the formulation product.
• Positive drug addiction (smoking, alcoholism, marijuana).
• Subjects with a history of participation in any clinical study in the last 40 days prior to their evaluation.
• incapacity to give informed consent owing to mental disorder or legal condition.
• Any major anomaly detected during the clinical examination, tests that could interfere with the performance of the study or with the efficacy and safety evaluations.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leopoldo Baiza, MD

Role: STUDY_DIRECTOR

Laboratorios Sophia

Locations

Unidad Medica "Grupo Pediátrico"

Guadalajara, Jalisco, Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOPH157-0114/II

Identifier Type: -

Identifier Source: org_study_id