Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (CORNWALL)
6 de marzo de 2013 actualizado por: CIBA VISION
Polymorphonuclear Leukocyte Response During Overnight Lens Wear
The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep.
The results from contact lens wearers were compared with the results from non-contact lens wearers.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers.
Tear samples were collected via a binocular eye-wash.
The samples were processed, and a cell count was performed using a hemacytometer.
Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).
Tipo de estudio
Intervencionista
Inscripción (Actual)
65
Fase
- No aplica
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
-
-
Ontario
-
Waterloo, Ontario, Canadá, N2L 3G1
- University of Waterloo Centre for Contact Lens Research
-
-
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
17 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 17 years of age or older.
- Ocular examination in the last two years.
- Has up-to-date spectacles.
Falls into one of the following three categories:
- Adapted wearer of Lotrafilcon A contact lenses
- Adapted wearer of Lotrafilcon B contact lenses
- Does not wear contact lenses
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Ocular disease
- Systemic or topical medications that may affect ocular health.
- Known sensitivity to diagnostic pharmaceuticals used in study.
- Uses artificial tears and/or rewetting drops.
- Wears contact lenses on an overnight basis for more than one night per week.
- Other protocol-defined 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: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Lotrafilcon A
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair.
After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
Otros nombres:
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Otros nombres:
|
|
Comparador activo: Lotrafilcon B
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair.
After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Otros nombres:
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Otros nombres:
|
|
Sin intervención: No lens wear
No contact lens wear for the duration of the study.
One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Leukocyte Population
Periodo de tiempo: Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA).
Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes.
The total amount of leukocytes for contact lens wearers and non-lens wearers is presented.
Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.
|
Week 5
|
|
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
Periodo de tiempo: Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion.
Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.
|
Week 5
|
|
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
Periodo de tiempo: Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
Oxidative response is reported as a ratio of activated to non-activated samples.
DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst.
Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe.
Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).
|
Week 5
|
|
Change From Week 1 in Leukocyte Population at Week 5
Periodo de tiempo: Week 1, Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA).
Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes.
The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
|
Week 1, Week 5
|
|
Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
Periodo de tiempo: Week 1, Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
Cell adhesion response is reported as a ratio of activated to non-activated samples.
The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
|
Week 1, Week 5
|
|
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
Periodo de tiempo: Week 1, Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
Oxidative response is reported as a ratio of activated to non-activated samples.
The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
|
Week 1, Week 5
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo
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
1 de mayo de 2011
Finalización primaria (Actual)
1 de enero de 2012
Finalización del estudio (Actual)
1 de enero de 2012
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2011
Publicado por primera vez (Estimar)
23 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de marzo de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
6 de marzo de 2013
Última verificación
1 de marzo de 2013
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- P-373-C-102
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. .