Formula Identification (FID) 114657 in Contact Lens Wearers
4 de octubre de 2016 actualizado por: Alcon Research
Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
234
Fase
- No aplica
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Must sign the informed consent form.
- Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
- Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1.
- Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1.
- Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
- Demonstrate symptoms of contact lens discomfort.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Routinely sleeping in lenses.
- Any active eye inflammation or condition that contraindicates contact lens wear.
- Any systemic diseases that could prevent successful contact lens wear.
- Use of systemic or ocular medications that contraindicate lens wear.
- Fit with only 1 contact lens.
- Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
- Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
- 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
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: FID 114657
FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
|
|
Comparador activo: Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
|
Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
Saline eye drops (15 ml)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
Periodo de tiempo: Day 1, after 2 hours of lens wear
|
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens).
The anterior-most layer of the pre-lens tear film consists of lipids.
Lipid layer thickness (LLT) is measured with the LipiView® Interferometer.
LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness.
Higher values of LLT indicate a better lubrication of the ocular surface.
A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film.
The right eye only was used for this measure.
|
Day 1, after 2 hours of lens wear
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
Periodo de tiempo: Baseline (Day 0), Day 14
|
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time.
Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day.
Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion.
The participant rated both eyes together by providing one single rating.
This outcome measure was prespecified for only FID 114657.
|
Baseline (Day 0), Day 14
|
|
Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses
Periodo de tiempo: Baseline (Day 0), Day 14
|
Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen.
A 1-unit increase indicates improvement.
The participant rated both eyes together by providing one single rating.
|
Baseline (Day 0), Day 14
|
|
Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14
Periodo de tiempo: Baseline (Day 0), Day 14
|
At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time.
Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day.
Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion.
A positive change from Baseline indicates improvement.
The participant rated both eyes together by providing one single rating.
|
Baseline (Day 0), Day 14
|
|
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14
Periodo de tiempo: Day 14, after 2 hours of lens wear
|
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens).
The anterior-most layer of the pre-lens tear film consists of lipids.
Lipid layer thickness (LLT) is measured with the LipiView® Interferometer.
LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness.
Higher values of LLT indicate a better lubrication of the ocular surface.
A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film.
The right eye only was used for this measure.
|
Day 14, after 2 hours of lens wear
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Manager, Pharmaceuticals, Global Medical Affairs, Alcon Research
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 noviembre de 2014
Finalización primaria (Actual)
1 de julio de 2015
Finalización del estudio (Actual)
1 de julio de 2015
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
17 de noviembre de 2014
Publicado por primera vez (Estimar)
18 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
4 de octubre de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LCO242-P001
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