A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
Ocular Redness
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
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 159 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 Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
Leer la descripción completa
The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
¿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:
- 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;
- History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
- Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
- Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
- Ocular redness at baseline as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Known contraindications or sensitivities to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
- Ocular surgical interventions within 6 months prior to Visit 1 or during the study;
- Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
- Disallowed medications or devices as specified in the protocol;
- Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
- Other protocol-defined 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%
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
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
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
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.
Medidas secundarias
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 1 Minute Post-instillation on Day 1
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).
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1
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).
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-instillation on Day 1
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).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (5)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
5 centros
Global Research ManagementGlendale, California, United StatesEstado desconocido
Oculus Research, Inc.Garner, North Carolina, United StatesEstado desconocido
Scott & Christie and Associates, PCCranberry Township, Pennsylvania, United StatesEstado desconocido
Emerson Clinical Research Institute, Inc.Falls Church, Virginia, United StatesEstado desconocido
Piedmont Eye CenterLynchburg, Virginia, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Alcon Research
- Inicio del estudio
- 21 ago 2024 Real
- Finalización primaria
- 14 nov 2024 Real
- Finalización del estudio
- 8 ene 2025 Real
- Primera publicación
- 5 jun 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 Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
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