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Uma investigação do FID 123320 para a redução da vermelhidão ocular em populações pediátricas e adultas

16 de outubro de 2026 atualizado por: Alcon Research

Um estudo multicêntrico, randomizado, duplo-mascarado, controlado por veículo, de eficácia e segurança de grupos paralelos da solução oftálmica FID 123320 para a redução da vermelhidão ocular em populações pediátricas e adultas

The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution (Apraclonidine HCl 0.125%) compared to Vehicle for relieving redness of the eye due to minor eye irritations in pediatric and adult populations.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This study will enroll 2 cohorts: An adult cohort (Subjects 18 years and older of age from any race and ethnicity) and a pediatric cohort (Subjects 5 - 17 years of age from any race and ethnicity).

The study will consist of 6 scheduled visits for each cohort: Screening and/or Baseline visit (Day -7 to -1, Visit 1), Eligibility verification/Randomization/1st Treatment visit on Day 1 (Visit 2), 2-week follow-up visit on Day 14 (Visit 3), 4-week follow-up visit on Day 28 (Visit 4), 8-week follow-up/Treatment discontinuation visit on Day 56 (Visit 5), and 7-day follow-up after treatment discontinuation/Exit visit on Day 63 (Visit 6). The primary endpoint will be collected at Day 1 (Visit 2).

The expected study duration for each subject is approximately 10 weeks with approximately 8 weeks (56 days) of investigational product (IP) exposure.

Tipo de estudo

Intervencional

Inscrição (Real)

284

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

  • Estados Unidos
    • California
      • Newport Beach, California, Estados Unidos, 92663
        • Eye Research Foundation
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • Vision Institute
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40206
        • Butchertown Clinical Trials
    • Massachusetts
      • Andover, Massachusetts, Estados Unidos, 01810
        • Andover Eye Associates
    • North Carolina
      • Apex, North Carolina, Estados Unidos, 27502
        • NC Eye Associates, OD, PLLC
      • Shelby, North Carolina, Estados Unidos, 28150
        • CORE, Inc.
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38119
        • Total Eye Care PA
      • Smyrna, Tennessee, Estados Unidos, 37167
        • Advancing Vision Research, LLC

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

5 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria - Adult Cohort:

  • Capable of giving signed informed consent;
  • Willing and able to follow all instructions and attend all study visits;
  • Able to self-administer eye drops in the opinion of the investigator;
  • Have a history of vasoconstrictor (redness relief drop) use within the last 6 months, have an interest in using over-the-counter (OTC) vasoconstrictor eye drops for redness relief, or would benefit from the use of redness relief drops in the opinion of the investigator;
  • Ocular health within normal limits, including distance best corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;
  • Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;
  • Other protocol-defined inclusion criteria may apply.

Key Inclusion Criteria - Pediatric Cohort:

  • All pediatric subjects: Parent or legal guardian signs informed consent;
  • Pediatric subject ages 7-17: Sign an assent form;
  • Subject and parent/legal guardian/care giver: Willing and able to follow all instructions and attend all study visits;
  • Able to self-administer eye drops satisfactorily or have a subject's care provider or parent/legal guardian at home routinely available for this purpose;
  • Ocular health within normal limits; best-corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;
  • Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria - Pediatric and Adult Cohorts

  • Known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
  • Ocular surgical intervention within 6 months prior to Visit 1 (Day -7 to Day -1) or during the study;
  • History of lid surgery;
  • Ocular condition that, in the opinion of the investigator, could affect the subject's safety or study parameters;
  • 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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Apraclonidine HCl 0.125% - Adult Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Medicamento: Apraclonidine Hydrochloride Ophthalmic Solution

Investigational ophthalmic solution applied topically to the eye with a dropper bottle

Outros nomes:
  • Apraclonidine HCl 0.125%
Comparador de Placebo: Vehicle - Adult Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Medicamento: Vehicle

Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
Experimental: Apraclonidine HCl 0.125% - Pediatric Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Medicamento: Apraclonidine Hydrochloride Ophthalmic Solution

Investigational ophthalmic solution applied topically to the eye with a dropper bottle

Outros nomes:
  • Apraclonidine HCl 0.125%
Comparador de Placebo: Vehicle - Pediatric Cohort

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).
Medicamento: Vehicle

Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-Instillation on Day 1 - Adult Cohort
Prazo: Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 10 Hours (600 Minutes) Post-Instillation on Day 1 - Adult Cohort
Prazo: Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Hour (60 Minutes) Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Prazo: Baseline (Day 1 pre-instillation); Hour 1 (60 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Hour 1 (60 minutes) (Day 1 post-instillation)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Adult Cohort
Prazo: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1 - Adult Cohort
Prazo: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-Instillation on Day 1 - Adult Cohort
Prazo: Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-instillation on Day 1 (Visit 2) - Adult Cohort
Prazo: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Prazo: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Prazo: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Prazo: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)

Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)

Colaboradores e Investigadores

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

Patrocinador

Alcon Research

Investigadores

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

Publicações e links úteis

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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)

7 de outubro de 2024

Conclusão Primária (Real)

27 de janeiro de 2025

Conclusão do estudo (Real)

3 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

2 de agosto de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de agosto de 2024

Primeira postagem (Real)

6 de agosto de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • DEW422-C003

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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