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: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Fluoroquinolones; Gatifloxacin; Ophthalmic Solutions; Pazufloxacin

Criteria

Inclusion Criteria:

• Signed informed consent.

• Age ≥ 1 year.

• Both genders.

• Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia

Exclusion Criteria:

• Pregnant women, lactating or planning to become pregnant.

• Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.

• Participation in another clinical research study ≤ 30 days before the baseline visit.

• Previous participation in this same study.

• That they can not comply with their attendance at appointments or with all the requirements of the protocol.

• Single eye

• Presence of corneal abrasion or corneal ulceration in the study eye.

• History Users of contact lenses who are not willing to suspend their use during the study.

• Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study.

• Antecedents of eye surgery 6 weeks prior to study entry.

• Viral or allergic conjunctivitis.

• Active uveitis.

• Active ulcerative keratitis.

• Recurrent corneal erosion syndrome

• Antecedent of hypersensitivity or allergy to fluoroquinolones.