Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
Status:
Terminated
Trial end date:
2020-03-24
Target enrollment:
Participant gender:
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).