Clinical trial NCT02980523: Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Conjunctivitis
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline Bacterial Culture
timeFrame: up to one week
measure: Adverse Events
timeFrame: during the intervention period for 7 days, and 15 days after the final visit
Secondary outcomes:
measure: Cases Frequency of Ocular Secretion
timeFrame: Up to one week.
measure: Number of Cases of Conjunctival Hyperemia
timeFrame: up to one week
measure: Chemosis Frequency
timeFrame: up to one week
measure: Eyelid Edema Frequency
timeFrame: Up to one week
measure: Frequency of Corneal Epithelial Defects
timeFrame: Up to one week
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad Medica "Grupo Pediátrico"
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia
name: Leopoldo Baiza, MD
role: STUDY_DIRECTOR
References: