NCT03696342|TerminatedPhase 3ResultsDMC
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Sponsor's convenience
PRO-157
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%.
Sponsor study identifier
interventional
46
1 country
6
Study Start
October 1, 2018
Actual (reported)Primary Completion
March 24, 2020
Actual (reported)Study Completion
March 24, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 24, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2018
Actual (reported)October 3, 2018
Actual (reported)October 4, 2018
Actual (reported)March 24, 2020
Actual (reported)March 24, 2020
Actual (reported)August 24, 2021
Actual (reported)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)
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)
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.
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.
Consultorio Dra. Patricia Culebro Solano
Guadalajara, Jalisco, 44100, Mexico
Juan Carlos Ochoa Tavares
Guadalajara, Jalisco, 44600, Mexico
Samuel altamirano Vallejo
Guadalajara, Jalisco, 44670, Mexico
Centro de investigación Medica Aguascalientes
Aguascalientes, 20116, Mexico
Juan Carlos Serna Ojeda (INBIOMEDyC)
Aguascalientes, 20190, Mexico
Instituto Nacional de Pediatria
Mexico City, 04530, Mexico
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.
Leopoldo Baiza Durán, MD
Laboratorios Sophia S.A de C.V.
46 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2018
First Posted
Contact the study team to confirm eligibility.
October 4, 2018
Study Start
October 1, 2018
Actual (reported)Primary Completion
March 24, 2020
Actual (reported)Study Completion
March 24, 2020
Actual (reported)Last Updated
August 24, 2021
Results First Posted
August 24, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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