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

NCT03696342 | Terminated Phase 3 Results DMC

• 1 other identifier: SOPH157-0217/III
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

pazufloxacin; PRO-157; Fluoroquinolones

Outcome Measures

Primary Outcomes (2)

• Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment

  The ocular secretion will be classified as 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The number will be reported according to the rating granted at final visit.

  will be evaluated at the end of the treatment (day 8, final visit)

• Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment

  Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. Will be graduated using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.

  will be evaluated at the end of the treatment (day 8, final visit)

Secondary Outcomes (4)

• Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment

  will be evaluated at the end of the treatment (day 8, final visit)

• Presence of Bacterial Eradication Compared to Baseline Culture Results

  will be evaluated at the end of the treatment (day 8, final visit)

• Adverse Events

  day 0 to day 17 (visit 0 to security call)

• Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit

  will be evaluated at the end of the treatment (day 8, final visit)

Study Arms (2)

PRO-157

EXPERIMENTAL

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: Pazufloxacin

Zymar

ACTIVE COMPARATOR

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.

Drug: Zymar

Interventions

Pazufloxacin DRUG

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.

Also known as: PRO-157

PRO-157

Zymar DRUG

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.

Also known as: gatifloxacin

Zymar

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age ≥ 1 year.
• Both genders.
• Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (6)

Consultorio Dra. Patricia Culebro Solano

Guadalajara, Jalisco, 44100, Mexico

Location

Juan Carlos Ochoa Tavares

Guadalajara, Jalisco, 44600, Mexico

Location

Samuel altamirano Vallejo

Guadalajara, Jalisco, 44670, Mexico

Location

Centro de investigación Medica Aguascalientes

Aguascalientes, 20116, Mexico

Location

Juan Carlos Serna Ojeda (INBIOMEDyC)

Aguascalientes, 20190, Mexico

Location

Instituto Nacional de Pediatria

Mexico City, 04530, Mexico

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

pazufloxacin; Gatifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This trial was terminated early due to the sponsor's convenience in the pipeline followed by the studied product. A small sample renders this results as merely descriptive.

Results Point of Contact

• Title: Dr. Alejandra Sanchez-Rios
• Organization: Medical Affairs Operations Chief

alejandra.sanchez@sophia.com.mx

33 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: clinical study of non-inferiority, multicenter, double-blind, with comparative group randomized

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 4, 2018
• Study Start: October 1, 2018
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-03

Locations

ME (6)