Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
Condition: Conjunctivitis, Bacterial
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Pazufloxacin; Zymar
Intervention description: 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.; 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.
Intervention MeSH terms: Gatifloxacin; Pazufloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: clinical study of non-inferiority, multicenter, double-blind, with comparative group randomized
Masking: Double (Participant, Investigator)
Masking description: In addition, the statistical analysis will be carried out in a blinded manner in the case of a partial and final analysis.
The masking will be done using boxes in the primary packaging identical in the two groups and relabelling the bottles of both interventions.
Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the assignment number.
Enrollment: 46.0
Sex: All
Minimum age: 1 Year
Maximum age: 99 Years
Healthy volunteers: No
Keywords: pazufloxacin; PRO-157; Fluoroquinolones

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).
    

Eligibility 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.