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

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
PRO-157
Vigamox
Zymar®
Lagricel Ofteno®
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis

Eligibility Criteria

1 Day - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Unidad Medica "Grupo Pediátrico"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

PRO-157 BID (2 times per day)

PRO-157 TID (3 times per day)

PRO-157 QID (4 times per day)

Moxifloxacin (Vigamox®)

Gatifloxacin (Zymar®)

Arm Description

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 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)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 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)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 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)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 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)

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 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)

Outcomes

Primary Outcome Measures

Change From Baseline Bacterial Culture
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.
Adverse Events
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.

Secondary Outcome Measures

Cases Frequency of Ocular Secretion
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.
Number of Cases of Conjunctival Hyperemia
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.
Chemosis Frequency
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.
Eyelid Edema Frequency
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.
Frequency of Corneal Epithelial Defects
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.

Full Information

First Posted
November 17, 2016
Last Updated
May 8, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02980523
Brief Title
Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)
Acronym
Pazufloxacin
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO-157 BID (2 times per day)
Arm Type
Experimental
Arm Description
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 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)
Arm Title
PRO-157 TID (3 times per day)
Arm Type
Experimental
Arm Description
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 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)
Arm Title
PRO-157 QID (4 times per day)
Arm Type
Experimental
Arm Description
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 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)
Arm Title
Moxifloxacin (Vigamox®)
Arm Type
Active Comparator
Arm Description
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 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)
Arm Title
Gatifloxacin (Zymar®)
Arm Type
Active Comparator
Arm Description
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 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)
Intervention Type
Drug
Intervention Name(s)
PRO-157
Other Intervention Name(s)
Pazufloxacin 0.06%, ophthalmic solution
Intervention Description
PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Vigamox
Other Intervention Name(s)
Moxifloxacin
Intervention Description
Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Zymar®
Other Intervention Name(s)
Gatifloxacin
Intervention Description
Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Lagricel Ofteno®
Other Intervention Name(s)
Sodium hyaluronate 0.4%
Intervention Description
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Primary Outcome Measure Information:
Title
Change From Baseline Bacterial Culture
Description
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.
Time Frame
up to one week
Title
Adverse Events
Description
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.
Time Frame
during the intervention period for 7 days, and 15 days after the final visit
Secondary Outcome Measure Information:
Title
Cases Frequency of Ocular Secretion
Description
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.
Time Frame
Up to one week.
Title
Number of Cases of Conjunctival Hyperemia
Description
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.
Time Frame
up to one week
Title
Chemosis Frequency
Description
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.
Time Frame
up to one week
Title
Eyelid Edema Frequency
Description
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.
Time Frame
Up to one week
Title
Frequency of Corneal Epithelial Defects
Description
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.
Time Frame
Up to one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo Baiza, MD
Organizational Affiliation
Laboratorios Sophia
Official's Role
Study Director
Facility Information:
Facility Name
Unidad Medica "Grupo Pediátrico"
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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