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

May 8, 2019 updated by: Laboratorios Sophia S.A de C.V.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Unidad Medica "Grupo Pediátrico"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Pazufloxacin 0.06%, ophthalmic solution
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Sodium hyaluronate 0.4%
EXPERIMENTAL: 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)
PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Pazufloxacin 0.06%, ophthalmic solution
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Sodium hyaluronate 0.4%
EXPERIMENTAL: 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)
PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Pazufloxacin 0.06%, ophthalmic solution
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Sodium hyaluronate 0.4%
ACTIVE_COMPARATOR: 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)
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Sodium hyaluronate 0.4%
Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
Other Names:
  • Moxifloxacin
ACTIVE_COMPARATOR: 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)
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Other Names:
  • Sodium hyaluronate 0.4%
Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
Other Names:
  • Gatifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Bacterial Culture
Time Frame: up to one week

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.

up to one week
Adverse Events
Time Frame: during the intervention period for 7 days, and 15 days after the final visit
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.
during the intervention period for 7 days, and 15 days after the final visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cases Frequency of Ocular Secretion
Time Frame: Up to one week.
Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
Up to one week.
Number of Cases of Conjunctival Hyperemia
Time Frame: up to one week
Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
up to one week
Chemosis Frequency
Time Frame: up to one week
Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
up to one week
Eyelid Edema Frequency
Time Frame: Up to one week

Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).

The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.

Up to one week
Frequency of Corneal Epithelial Defects
Time Frame: Up to one week

Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.

The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.

Up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Leopoldo Baiza, MD, Laboratorios Sophia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

December 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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