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

1 de fevereiro de 2021 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

139

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Regenstauf, Alemanha, 93128
        • Pfizer Investigational Site
      • Schorndorf, Alemanha, 73614
        • Pfizer Investigational Site
  • Bélgica
      • Leuven, Bélgica, 3000
        • Pfizer Investigational Site
  • Colômbia
    • Antioquia
      • Medellín, Antioquia, Colômbia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colômbia, 0000
        • Pfizer Investigational Site
  • Eslováquia
      • Bratislava, Eslováquia, 83340
        • Pfizer Investigational Site
  • Eslovênia
      • Ljubljana, Eslovênia, 1000
        • Pfizer Investigational Site
  • Espanha
      • Madrid, Espanha, 28040
        • Pfizer Investigational Site
      • Sevilla, Espanha, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Espanha, 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
  • Federação Russa
      • Moscow, Federação Russa, 119331
        • Pfizer Investigational Site
      • St. Petersburg, Federação Russa, 194100
        • Pfizer Investigational Site
  • Filipinas
      • Makati City, Filipinas, 1200
        • Pfizer Investigational Site
      • Mandaluyong City, Filipinas, 1500
        • Pfizer Investigational Site
  • França
      • Lille Cedex, França, 59037
        • Pfizer Investigational Site
      • Lyon, França, 69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens, Cedex 1, França, 80054
        • Pfizer Investigational Site
  • Itália
      • Catania, Itália, 95123
        • Pfizer Investigational Site
      • Milano, Itália, 20162
        • Pfizer Investigational Site
  • Polônia
      • Bialystok, Polônia, 15-274
        • Pfizer Investigational Site
      • Gdansk, Polônia, 80-211
        • Pfizer Investigational Site
      • Wroclaw, Polônia, 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
  • Romênia
    • Cluj
      • Cluj-Napoca, Cluj, Romênia, 400006
        • Pfizer Investigational Site
  • Sérvia
      • Belgrade, Sérvia, 11000
        • Pfizer Investigational Site
  • Tcheca
      • Praha 5, Tcheca, 150 06
        • Pfizer Investigational Site
  • Ucrânia
      • Kharkiv, Ucrânia, 61000
        • Pfizer Investigational Site
      • Kyiv, Ucrânia
        • Pfizer Investigational Site
      • Kyiv, Ucrânia, 04050
        • Pfizer Investigational Site
      • Kyiv, Ucrânia, 01135
        • Pfizer Investigational Site
      • Odesa, Ucrânia, 65061
        • Pfizer Investigational Site
  • África do Sul
      • Myfair West, África do Sul, 2109
        • Pfizer Investigational Site
  • Índia
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Índia, 500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, Índia, 380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, Índia, 641 014
        • Pfizer Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

8 meses a 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Timolol
Medicamento: Timolol
Timolol 0.5% dosed twice-daily
Experimental: latanoprost
Medicamento: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Reduction From Baseline in Mean IOP at Week 1
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2008

Conclusão Primária (Real)

1 de novembro de 2009

Conclusão do estudo (Real)

1 de novembro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

14 de julho de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de julho de 2008

Primeira postagem (Estimativa)

16 de julho de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de fevereiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de fevereiro de 2021

Última verificação

1 de janeiro de 2011

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A6111137

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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