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Trial record 25 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%. (PRO-157)

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ClinicalTrials.gov Identifier: NCT03696342
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

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).


Condition or disease Intervention/treatment Phase
Conjunctivitis, Bacterial Drug: Pazufloxacin Drug: Zymar Phase 3

Detailed Description:

The study subjects will be recruited from various research centers in western and central Mexico.

Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.

The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.

The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.

The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.

To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey).

The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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.

Primary Purpose: Treatment
Official Title: Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: PRO-157

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

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.

Other Name: PRO-157

Active Comparator: 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.

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.

Other Name: gatifloxacin




Primary Outcome Measures :
  1. Conjunctival secretion [ Time Frame: will be evaluated at the end of the treatment (day 8, final visit) ]
    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.

  2. Conjunctival bulbar hyperemia [ Time Frame: will be evaluated at the end of the treatment (day 8, final visit) ]

    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. He will graduate using the Efron scale.

    0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.



Secondary Outcome Measures :
  1. Overall rating (global qualification) [ Time Frame: will be evaluated at the end of the treatment (day 8, final visit) ]
    The global qualification of the investigator constitutes the integral judgment of the clinical picture of the subject, including signs and symptoms, after a routine ophthalmological evaluation and interrogation. It will be classified 0 = cure, 1 = improvement, 2 = no changes compared to before starting treatment, 3 = worsened. It will be registered in the CRF in each of the follow-up visits.

  2. Bacterial eradication [ Time Frame: will be evaluated at the end of the treatment (day 8, final visit) ]
    The conjunctival secretion sample will be taken prior to the instillation of any medication, the result of the basal crop will be compared against the results of the final crop and the absence of bacterial species that were present in the culture of the baseline visit is considered bacterial eradication.

  3. Adverse events [ Time Frame: day 0 to day 17 (visit 0 to security call) ]
    The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis

  4. Clinical remission [ Time Frame: will be evaluated at the end of the treatment (day 8, final visit) ]
    The clinical remission in the visits will be evaluated as "Yes" or "No", to report "Yes" it must have a grade of "0" in conjunctival hyperemia and "0" in secretion; otherwise, you must report as "No".



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696342


Contacts
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Contact: Ricardo Llamas, PhD +52 (33) 3001 4200 ext 1259 ricardo.llamas@sophia.com.mx
Contact: Oscar Olvera, MD +52 (33) 3001 4200 ext 1074 oscar.olvera@sophia.com.mx

Locations
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Mexico
Consultorio Dra. Patricia Culebro Solano Recruiting
Guadalajara, Jalisco, Mexico, 44100
Contact: Patricia Culebro Solano, MD    +523338252130    pattyculebro@hotmail.com   
Contact: Francisco Chavez Mendez, MD    +523338252130    fchavezmendez@hotmail.com   
Juan Carlos Ochoa Tavares Recruiting
Guadalajara, Jalisco, Mexico, 44600
Contact: Juan C. Ochoa, MD    52+ (33) 36131372    ochoa@cornea.com.mx   
Samuel altamirano Vallejo Recruiting
Guadalajara, Jalisco, Mexico, 44670
Contact: Monica Camarena Diaz, MD    +5213336410340    mcamarena@fsanmarcos.com   
Contact: Jose Arturo Gomez Carrazco, MD    +5213336410340    agomez@fubas.org.mx   
Centro de investigación Medica Aguascalientes Recruiting
Aguascalientes, Mexico, 20116
Contact: Tanya Adabache Guel, MD    +524499949458    taniaadabache.ags@osmomexico.com   
Contact: Salvador Perez Jaime, MD    +524499949458    perezjaime.salvador@gmail.com   
Juan Carlos Serna Ojeda (INBIOMEDyC) Recruiting
Aguascalientes, Mexico, 20190
Contact: Juan Carlos Serna Ojeda, MD    +524499702831    contacto@drserenaojeda.com   
Contact: Gerardo Tiscareño trujillo    +524499702831    gueps1984@hotmail.com   
Instituto Nacional de Pediatria Recruiting
Mexico City, Mexico, 04530
Contact: Jose Luis Arredondo García, MD    +5255 1084 0900    arredondo.joseluis@gmail.com   
Contact: Ana Maria Borcolla, MD    +5255 1084 0900    ambp09@gmail.com   
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
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Study Director: Leopoldo Baiza Durán, MD Laboratorios Sophia S.A de C.V.
  Study Documents (Full-Text)

Documents provided by Laboratorios Sophia S.A de C.V.:
Study Protocol  [PDF] January 19, 2018


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Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT03696342     History of Changes
Other Study ID Numbers: SOPH157-0217/III
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Sophia S.A de C.V.:
pazufloxacin
PRO-157
Fluoroquinolones
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Gatifloxacin
Pazufloxacin
Fluoroquinolones
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors