Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Rocklatan de próxima generación

4 de noviembre de 2026 actualizado por: Alcon Research

Un estudio de dosis-respuesta de fase II, prospectivo, de dos etapas, doble enmascarado, aleatorizado, multicéntrico, controlado, que evalúa la seguridad y la eficacia hipotensora ocular de las soluciones oftálmicas AR-17043 y PG043 (AR-17043 / Latanoprost) en sujetos Con presión 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

646

Fase

  • Fase 2

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

  • 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

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

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
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.
Droga: AR-17043 Ophthalmic Solution

Investigational monotherapy supplied in three concentration levels: low, medium, high
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.
Droga: AR-17043 Ophthalmic Solution

Investigational monotherapy supplied in three concentration levels: low, medium, high
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.
Droga: AR-17043 Ophthalmic Solution

Investigational monotherapy supplied in three concentration levels: low, medium, high
Comparador de placebos: 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.
Droga: AR-17043 Vehicle

Placebo comparator
Comparador activo: 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.
Droga: Netarsudil 0.02% Ophthalmic Solution

Marketed monotherapy

Otros nombres:
  • Rhopressa®
Experimental: PG043 low concentration (Stage 2)

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

Investigational fixed dose combination supplied in two concentration levels: low and high
Experimental: PG043 high concentration (Stage 2)

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

Investigational fixed dose combination supplied in two concentration levels: low and high
Comparador activo: AR-17043 high concentration (Stage 2)

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

Investigational monotherapy supplied in three concentration levels: low, medium, high
Comparador activo: Latanoprost (Stage 2)

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

Marketed monotherapy

Otros nombres:
  • Latanoprost
Comparador activo: Rocklatan (Stage 2)

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

Marketed fixed dose combination

Otros nombres:
  • Rocklatan®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean diurnal IOP at Day 8 (Stage 1)
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean IOP at each post-treatment timepoint (Stage 1)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

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

Patrocinador

Alcon Research

Investigadores

  • Director de estudio: Clinical Trial Lead, Pharma, Alcon Research, LLC

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 (Actual)

4 de septiembre de 2024

Finalización primaria (Actual)

14 de noviembre de 2025

Finalización del estudio (Actual)

14 de noviembre de 2025

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2024

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2024

Publicado por primera vez (Actual)

4 de junio de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

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

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GLR305-E001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir