An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
Ocular Redness · Eye Irritation
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 5 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 284 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
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).
Drug: Apraclonidine Hydrochloride Ophthalmic Solution
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).
Drug: Vehicle
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).
Drug: Apraclonidine Hydrochloride Ophthalmic Solution
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).
Drug: Vehicle
Apraclonidine Hydrochloride Ophthalmic Solution DRUG
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
Vehicle DRUG
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-Instillation on Day 1 - Adult Cohort
Plazo: 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.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 10 Hours (600 Minutes) Post-Instillation on Day 1 - Adult Cohort
Plazo: 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.
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)
Plazo: 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.
Medidas secundarias
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Adult Cohort
Plazo: 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.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1 - Adult Cohort
Plazo: 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.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-Instillation on Day 1 - Adult Cohort
Plazo: 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.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-instillation on Day 1 (Visit 2) - Adult Cohort
Plazo: 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.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Plazo: 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.
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)
Plazo: 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.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (8)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
8 centros
Eye Research FoundationNewport Beach, California, United StatesEstado desconocido
Vision InstituteColorado Springs, Colorado, United StatesEstado desconocido
Butchertown Clinical TrialsLouisville, Kentucky, United StatesEstado desconocido
Andover Eye AssociatesAndover, Massachusetts, United StatesEstado desconocido
NC Eye Associates, OD, PLLCApex, North Carolina, United StatesEstado desconocido
CORE, Inc.Shelby, North Carolina, United StatesEstado desconocido
Total Eye Care PAMemphis, Tennessee, United StatesEstado desconocido
Advancing Vision Research, LLCSmyrna, Tennessee, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Alcon Research
- Inicio del estudio
- 7 oct 2024 Real
- Finalización primaria
- 27 ene 2025 Real
- Finalización del estudio
- 3 abr 2025 Real
- Primera publicación
- 6 ago 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Efficacy and Safety Study of FID 123320 Ophthalmic Solution for the Reduction of Ocular Redness in Pediatric and Adult Populations
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026