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Rocklatan da próxima geração

6 de novembro de 2026 atualizado por: Alcon Research

Um estudo de fase II, prospectivo, de dois estágios, duplo-mascarado, randomizado, multicêntrico, controlado, de dose-resposta, avaliando a segurança e a eficácia hipotensora ocular de soluções oftálmicas AR-17043 e PG043 (AR-17043/Latanoprost) em indivíduos Com pressão intraocular elevada

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The study consists of two sequential stages under a single protocol. Stage 1 and Stage 2 will enroll independent participant cohorts. Subject enrolled in Stage 1 will not be eligible to participate in Stage 2.

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Tipo de estudo

Intervencional

Inscrição (Real)

646

Estágio

  • Fase 2

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

  • Estados Unidos
    • Alabama
      • Dothan, Alabama, Estados Unidos, 36301
        • Trinity Research Group
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85003
        • Eye Doctors of Arizona
    • California
      • Garden Grove, California, Estados Unidos, 92843
        • Orange County Ophthalmology Medical Group
      • Inglewood, California, Estados Unidos, 90301
        • United Medical Research Institute
      • Newport Beach, California, Estados Unidos, 92663
        • Eye Research Foundation
      • Petaluma, California, Estados Unidos, 94954
        • North Bay Eye Associates
    • Colorado
      • Fort Collins, Colorado, Estados Unidos, 80528
        • Eye Center of Northern Colorado, PC
    • Florida
      • Delray Beach, Florida, Estados Unidos, 33484
        • Glaucoma Specialists of South Florida
      • Delray Beach, Florida, Estados Unidos, 33484
        • Bruce A. Segal MD
      • Lakeland, Florida, Estados Unidos, 33805
        • Central Florida Eye Associates
      • Mt. Dora, Florida, Estados Unidos, 32757
        • Mid Florida Eye Center
      • Venice, Florida, Estados Unidos, 34285
        • Center For Sight
    • Georgia
      • Roswell, Georgia, Estados Unidos, 30076
        • Coastal Research Associates
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64154
        • Moyes Eye Center
    • New York
      • Rochester, New York, Estados Unidos, 14618
        • Rochester Ophthalmological Group
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27101
        • James D. Branch Ophthalmology
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58103
        • Bergstrom Eye Research
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45242
        • Cincinnati Eye Institute
      • Cincinnati, Ohio, Estados Unidos, 45236
        • Midwest Eye Center
    • Pennsylvania
      • Cranberry Township, Pennsylvania, Estados Unidos, 16066
        • Scott & Christie and Associates, PC
    • South Carolina
      • Mt. Pleasant, South Carolina, Estados Unidos, 29464
        • Carolina Eyecare Physicians LLC
    • Tennessee
      • Maryville, Tennessee, Estados Unidos, 37803
        • University Eye Specialists
      • Memphis, Tennessee, Estados Unidos, 38119
        • Total Eye Care PA
    • Texas
      • Dallas, Texas, Estados Unidos, 75243
        • Key-Whitman Eye Center
    • Virginia
      • Lynchburg, Virginia, Estados Unidos, 24502
        • Piedmont Eye Center

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Stage 1 Key Inclusion Criteria;

  • Diagnosis of OAG or OHT in both eyes.
  • High unmedicated IOP measurements in the study eye as specified in the protocol.
  • Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
  • Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

  • Diagnosis of OAG or OHT in both eyes.
  • High unmedicated IOP measurements in the study eye as specified in the protocol.
  • Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
  • Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

  • Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
  • Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
  • Glaucoma other than OAG.
  • Previous glaucoma surgery.
  • Any abnormality preventing reliable measurements.
  • Unable to demonstrate proper eyedrop instillation.
  • Other protocol-specified exclusion criteria may apply.

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
Experimental: AR-17043 low concentration (Stage 1)

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Medicamento: AR-17043 Ophthalmic Solution

Investigational monotherapy
Experimental: AR-17043 medium concentration (Stage 1)

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Medicamento: AR-17043 Ophthalmic Solution

Investigational monotherapy
Experimental: AR-17043 high concentration (Stage 1)

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Medicamento: AR-17043 Ophthalmic Solution

Investigational monotherapy
Comparador de Placebo: AR-17043 vehicle (Stage 1)

AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Medicamento: AR-17043 Vehicle

Placebo comparator
Comparador Ativo: Rhopressa (Stage 1)

Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Medicamento: Netarsudil 0.02% Ophthalmic Solution

Marketed monotherapy

Outros nomes:
  • Rhopressa®
Experimental: PG043 low concentration (Stage 2)

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Medicamento: PG043 Ophthalmic Solution

Investigational fixed dose combination
Experimental: PG043 high concentration (Stage 2)

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Medicamento: PG043 Ophthalmic Solution

Investigational fixed dose combination
Comparador Ativo: AR-17043 high concentration (Stage 2)

AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Medicamento: AR-17043 Ophthalmic Solution

Investigational monotherapy
Comparador Ativo: Latanoprost (Stage 2)

Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Medicamento: Latanoprost 0.005% Ophthalmic Solution

Marketed monotherapy

Outros nomes:
  • Latanoprosta
Comparador Ativo: Rocklatan (Stage 2)

Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Medicamento: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

Marketed fixed dose combination

Outros nomes:
  • Rocklatan®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean diurnal IOP at Day 8 (Stage 1)
Prazo: Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.
Day 8 (8:00, 10:00, 12:00, 16:00)
Mean diurnal IOP at Day 29 (Stage 2)
Prazo: Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.
Day 29 (8:00, 10:00, 16:00)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean IOP at each post-treatment timepoint (Stage 1)
Prazo: Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Prazo: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Prazo: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Prazo: Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Prazo: Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean IOP at each post-treatment timepoint (Stage 2)
Prazo: Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Prazo: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)
Prazo: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Prazo: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)
Prazo: Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Colaboradores e Investigadores

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

Patrocinador

Alcon Research

Investigadores

  • Diretor de estudo: Clinical Trial Lead, Pharma, Alcon Research, LLC

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 (Real)

4 de setembro de 2024

Conclusão Primária (Real)

14 de novembro de 2025

Conclusão do estudo (Real)

14 de novembro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

29 de maio de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2024

Primeira postagem (Real)

4 de junho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GLR305-E001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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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