Una investigación de FID 123320 para la reducción del enrojecimiento ocular en poblaciones pediátricas y adultas
Un estudio multicéntrico, aleatorizado, de doble enmascaramiento, controlado por vehículo y de grupos paralelos sobre la eficacia y seguridad de la solución oftálmica FID 123320 para la reducción del enrojecimiento ocular en poblaciones pediátricas y 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Newport Beach, California, Estados Unidos, 92663
- Eye Research Foundation
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80907
- Vision Institute
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40206
- Butchertown Clinical Trials
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Massachusetts
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Andover, Massachusetts, Estados Unidos, 01810
- Andover Eye Associates
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North Carolina
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Apex, North Carolina, Estados Unidos, 27502
- NC Eye Associates, OD, PLLC
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Shelby, North Carolina, Estados Unidos, 28150
- CORE, Inc.
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
- Total Eye Care PA
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Smyrna, Tennessee, Estados Unidos, 37167
- Advancing Vision Research, LLC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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). |
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
Otros nombres:
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Comparador de placebos: 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). |
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). |
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
Otros nombres:
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Comparador de placebos: 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). |
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-Instillation on Day 1 - Adult Cohort
Periodo de tiempo: Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
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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)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 10 Hours (600 Minutes) Post-Instillation on Day 1 - Adult Cohort
Periodo de tiempo: Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
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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)
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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)
Periodo de tiempo: Baseline (Day 1 pre-instillation); Hour 1 (60 minutes) (Day 1 post-instillation)
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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)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Adult Cohort
Periodo de tiempo: 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)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1 - Adult Cohort
Periodo de tiempo: 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)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-Instillation on Day 1 - Adult Cohort
Periodo de tiempo: 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)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-instillation on Day 1 (Visit 2) - Adult Cohort
Periodo de tiempo: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)
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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)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Periodo de tiempo: 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)
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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)
Periodo de tiempo: 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)
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Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Periodo de tiempo: 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)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Sr. Clinical Trial Lead, Pharma, Alcon Research, LLC
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- DEW422-C003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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