Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
Test lens
+ control lens
Enfermedades Oculares
+ Miopía
+ Errores Refractivos
Estudio de Tratamiento
Resumen
Fecha de inicio: 18 de abril de 2018
Fecha en la que se inscribió al primer participante.This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 77 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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.De 18 a 35 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: A person is eligible for inclusion in the study if he/she: * Is between 18 and 35 years of age (inclusive) * Has read and signed the informed consent letter * Is willing and anticipated to follow instructions and maintain the appointment schedule * Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day. * Habitually wears or is able to be adequately refit into MyDay Sphere lenses * Demonstrates an acceptable fit with the study lenses * Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses * Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week. * Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye * Has clear corneas and no active ocular disease * Has a contact lens refraction that fits within the available parameters of the study lenses. Exclusion Criteria: A person will be excluded from the study if he/she: * Is participating in any concurrent clinical research study * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has a systemic condition that, in the opinion of the investigator, may affect the study measures * Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures. * Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Significant pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (or history in past year) * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study * Has aphakia, keratoconus or a highly irregular cornea. * Has presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone refractive surgery. * Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment * Has participated in any other type of eye related clinical or research study within the last 7 days * Is habitually using rewetting/ lubricating eye drops (more than once per day)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 4 ubicaciones
Golden Optometric Group
Whittier, United StatesGolden Vision
Sarasota, United StatesNittany Eye Associates
State College, United States