- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01857102
Toric Eye Strain and Stability Study
18 de junio de 2018 actualizado por: Johnson & Johnson Vision Care, Inc.
The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
159
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
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Texas
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Houston, Texas, Estados Unidos, 77204
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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 a 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- The subject must have read, understand, and sign the statement of informed consent and receive a fully executed copy of the Informed Consent Form.
- The subject must appear able and willing to adhere to the instructions set forth in this protocol.
- The subject must be between 18 years and 45 years of age (inclusive).
- The subject must have best-corrected Snellen visual acuity of 20/30 or better in each eye.
- If the subject has ever worn contact lenses, the subject must be a current wearer of soft spherical contact lenses for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
- Subjective refraction must result in a vertex-corrected astigmatic contact lens prescription requiring at least -0.75 DC but not more than -1.75 DC cylindrical contact lens correction in each eye.
- Subjective refraction must result in a vertex-corrected spherical contact lens prescription between +0.25D to +4.00D or between-0.50D to -9.00D in each eye.
- The subject must not have the need for presbyopic correction (i.e., they must not be using as add in spectacles or wearing multifocal or monofocal contact lenses).
- The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
- The subject must have access to the internet throughout the day (either desktop and/or smartphone) and be willing to answer a web-based survey within 1 hour of receiving a text message based notification throughout the day for up to 8 days, throughout the study duration.
Exclusion Criteria:
- Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued)
- Any previous ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. greater than or equal to grade 3 finding of edema, corneal neovascularization, corneal staining, conjunctival injection, blepharitis/meibomian gland dysfunction) on the FDA classification scale or any other ocular abnormality that in the opinion of the investigator may contraindicate contact lens wear.
- Any ocular infection
- Current use of topical ophthalmic medications other than artificial tears/rewetting drops.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
- Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
- Employee of the investigational clinic (e.g. investigator, coordinator, technician)
- Subject does not have a wearable pair of spectacles.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: etafilcon A/etafilcon A for Astigmatism
Subjects were randomized to one of two sequences of lens wear.
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Soft contact lens to be worn in a daily wear, daily disposable modality for one week
Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week.
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Experimental: etafilcon A for Astigmatism/etafilcon A
Subjects were randomized to one of two sequences of lens wear.
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Soft contact lens to be worn in a daily wear, daily disposable modality for one week
Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Objective Comfort Assessed by Electromyography(EMG)
Periodo de tiempo: 1 week
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Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle.
The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit.
This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting.
The palpebral portion of this muscle closes the eyelids.
The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain.
The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording.
The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.
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1 week
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Visual Comfort
Periodo de tiempo: 1-week follow-up
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The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0.
The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life.
This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction.
An overall score is calculated by averaging the subscales.
The overall scores can take on values of 0 to 100.
Higher scores indicate better outcomes
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1-week follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 septiembre de 2013
Finalización primaria (Actual)
1 de junio de 2014
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2013
Publicado por primera vez (Estimar)
20 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2018
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR-5363
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. .
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