Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy
Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.
Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Visalia, California, Estados Unidos, 93277
- Reclutamiento
- Eye Surgical and Medical Associates
-
Contacto:
- Michael Boone, MD
- Número de teléfono: 559-627-9393
- Correo electrónico: drboone@visaliaeyecare.com
-
Contacto:
- Amy Smith
- Número de teléfono: (559)627-9393
- Correo electrónico: amys@visaliaeyecare.com
-
Sub-Investigador:
- Michael Boone, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
- Male or Female patients aged at least 18 years of age.
- Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
- A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
- Best-Corrected Visual Acuity of 20/800 or better in both eyes
- Written informed consent.
- Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.
Exclusion Criteria:
- Uncontrolled glaucoma
- Glaucoma requiring more than a single agent for IOP control
- Patients with a corneal thickness greater then 620 micrometers
- Female patients who are pregnant, nursing, or planning a pregnancy during the study
- Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
- Uncontrolled or labile hypertension
- At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Intraocular Pressure
Periodo de tiempo: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Heart Rate
Periodo de tiempo: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Blood Pressure
Periodo de tiempo: Day one, every hour for twelve hours.
|
Day one, every hour for twelve hours.
|
|
Intraocular Pressure
Periodo de tiempo: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Intraocular Pressure
Periodo de tiempo: Day seven, once.
|
Day seven, once.
|
|
Intraocular Pressure
Periodo de tiempo: Day fourteen, once.
|
Day fourteen, once.
|
|
Intraocular Pressure
Periodo de tiempo: Day twenty one, once.
|
Day twenty one, once.
|
|
Intraocular Pressure
Periodo de tiempo: Day twenty eight, once.
|
Day twenty eight, once.
|
|
Heart Rate
Periodo de tiempo: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Heart Rate
Periodo de tiempo: Day seven, once.
|
Day seven, once.
|
|
Heart Rate
Periodo de tiempo: Day fourteen, once.
|
Day fourteen, once.
|
|
Heart Rate
Periodo de tiempo: Day twenty one, once.
|
Day twenty one, once.
|
|
Heart Rate
Periodo de tiempo: Day twenty eight, once.
|
Day twenty eight, once.
|
|
Blood Pressure
Periodo de tiempo: Day two twice, once in the AM, once in the PM.
|
Day two twice, once in the AM, once in the PM.
|
|
Blood Pressure
Periodo de tiempo: Day seven, once.
|
Day seven, once.
|
|
Blood Pressure
Periodo de tiempo: Day fourteen, once.
|
Day fourteen, once.
|
|
Blood Pressure
Periodo de tiempo: Day twenty one, once.
|
Day twenty one, once.
|
|
Blood Pressure
Periodo de tiempo: Day twenty eight, once.
|
Day twenty eight, once.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Padma Nanduri, MD
- Director de estudio: Michael Boone, MD
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de los ojos
- Hipertensión Ocular
- Glaucoma
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes antihipertensivos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Tartrato de brimonidina
Otros números de identificación del estudio
- White Rabbit 2010-0001
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. .