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Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.

NCT03696342 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-08-24

Study results available
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Summary

Phase III clinical study of non-inferiority, multicenter, double-blind, with comparative group, of parallel groups and randomized. about a ophthalmic topical antibiotic for the treatment of bacterial conjunctivitis.

Goal:To compare the efficacy of the ophthalmic solution of pazufloxacin 0.6%, against the ophthalmic solution of gatifloxacin 0.3%, in the treatment of acute bacterial conjunctivitis.

Hypothesis:the ophthalmic solution PRO-157 is not inferior in the treatment of bacterial conjunctivitis, compared to the ophthalmic solution of gatifloxacin 0.3%, by means of the clinical remission of the disease.

Number of patients:

160 patients, each one will provide an eye for efficacy analysis, divided into 2 groups (80 eyes per group).

Conditions

  • Conjunctivitis, Bacterial

Interventions

DRUG

Pazufloxacin

Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.

DRUG

Zymar

Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo Baiza Durán, MD · Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-03-24
Completion
2020-03-24

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696342 on ClinicalTrials.gov