Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
Senofilcon A; Comfilcon A
+ Comfilcon A; Senofilcon A
+ Senofilcon A; Comfilcon A
Enfermedades Oculares
+ Errores Refractivos
+ Miopía
Otro tipo de estudio
Resumen
Fecha de inicio: 1 de agosto de 2012
Fecha en la que se inscribió al primer participante.Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 61 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro Tipo de Estudio
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Subjects must satisfy the following conditions prior to inclusion in the study: Has had an oculo-visual examination in the last two years Is at least 18 years of age and has full legal capacity to volunteer Has read and understood the information consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction Currently wears soft contact lenses at least 3 days a week, 8 hours a day Has clear corneas and no active ocular disease Has not worn lenses for at least 12 hours before the examination Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No amblyopia No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes) No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection). No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology) No aphakia Has prescription to match the available power range. Exclusion Criteria: Any of the following will render a subject ineligible for inclusion: Greater than 0.75 of refractive astigmatism in either eye Has never worn contact lenses before Wears contact lenses on an extended wear basis Has any systemic disease affecting ocular health Is a known sufferer of ocular allergies Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities Is aphakic Has undergone corneal refractive surgery. Is wearing monovision Is participating in any other type of clinical or research study Female who is currently pregnant or is breast-feeding Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
University of Houston College of Optometry, TERTC
Houston, United StatesAbrir University of Houston College of Optometry, TERTC en Google Maps