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A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

1 de febrero de 2021 actualizado por: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

139

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Regenstauf, Alemania, 93128
        • Pfizer Investigational Site
      • Schorndorf, Alemania, 73614
        • Pfizer Investigational Site
  • Bélgica
      • Leuven, Bélgica, 3000
        • Pfizer Investigational Site
  • Chequia
      • Praha 5, Chequia, 150 06
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 0000
        • Pfizer Investigational Site
  • Eslovaquia
      • Bratislava, Eslovaquia, 83340
        • Pfizer Investigational Site
  • Eslovenia
      • Ljubljana, Eslovenia, 1000
        • Pfizer Investigational Site
  • España
      • Madrid, España, 28040
        • Pfizer Investigational Site
      • Sevilla, España, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, España, 08950
        • Pfizer Investigational Site
  • Estados Unidos
    • Florida
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, Estados Unidos, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, Estados Unidos, 89148
        • Pfizer Investigational Site
  • Federación Rusa
      • Moscow, Federación Rusa, 119331
        • Pfizer Investigational Site
      • St. Petersburg, Federación Rusa, 194100
        • Pfizer Investigational Site
  • Filipinas
      • Makati City, Filipinas, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, Filipinas, 1500
        • Pfizer Investigational Site
  • Francia
      • Lille Cedex, Francia, 59037
        • Pfizer Investigational Site
      • Lyon, Francia, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, Francia, 80054
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, India, 641 014
        • Pfizer Investigational Site
  • Italia
      • Catania, Italia, 95123
        • Pfizer Investigational Site
      • Milano, Italia, 20162
        • Pfizer Investigational Site
  • Polonia
      • Bialystok, Polonia, 15-274
        • Pfizer Investigational Site
      • Gdansk, Polonia, 80-211
        • Pfizer Investigational Site
      • Wroclaw, Polonia, 50-368
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-548
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1649-035
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1169-019
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1169-097
        • Pfizer Investigational Site
      • Porto, Portugal, 4099-001
        • Pfizer Investigational Site
  • Reino Unido
      • Birmingham, Reino Unido, B18 7QH
        • Pfizer Investigational Site
      • London, Reino Unido, EC1V 2PD
        • Pfizer Investigational Site
  • Rumania
    • Cluj
      • Cluj-Napoca, Cluj, Rumania, 400006
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
  • Sudáfrica
      • Myfair West, Sudáfrica, 2109
        • Pfizer Investigational Site
  • Ucrania
      • Kharkiv, Ucrania, 61000
        • Pfizer Investigational Site
      • Kyiv, Ucrania
        • Pfizer Investigational Site
      • Kyiv, Ucrania, 04050
        • Pfizer Investigational Site
      • Kyiv, Ucrania, 01135
        • Pfizer Investigational Site
      • Odesa, Ucrania, 65061
        • Pfizer Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

8 meses a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female of 18 years of age or under
  • Diagnosis of glaucoma
  • IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

  • Require surgery for acute angle closure
  • Have had prior cyclodestructive procedures
  • Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Timolol
Droga: Timolol
Timolol 0.5% dosed twice-daily
Experimental: latanoprost
Droga: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Periodo de tiempo: Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reduction From Baseline in Mean IOP at Week 1
Periodo de tiempo: Baseline, Week 1
Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 1
Reduction From Baseline in Mean IOP at Week 4
Periodo de tiempo: Baseline, Week 4
Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)
Periodo de tiempo: Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 12
Mean IOP at Baseline
Periodo de tiempo: Baseline
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline
Mean IOP at Week 1
Periodo de tiempo: Week 1
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 1
Mean IOP at Week 4
Periodo de tiempo: Week 4
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 4
Mean IOP at Week 12
Periodo de tiempo: Week 12
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 12
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
Periodo de tiempo: Baseline, Week 4, and Week 12
Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 4, and Week 12
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
Periodo de tiempo: Baseline through Week 12
An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.
Baseline through Week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2008

Finalización primaria (Actual)

1 de noviembre de 2009

Finalización del estudio (Actual)

1 de noviembre de 2009

Fechas de registro del estudio

Enviado por primera vez

14 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

14 de julio de 2008

Publicado por primera vez (Estimar)

16 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

1 de febrero de 2021

Última verificación

1 de enero de 2011

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A6111137

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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