Corneal and Conjunctival Sensitivity and Staining Study
Optifree RepleniSH Multipurpose Disinfecting Solution
+ ReNu Multiplus Multipurpose Solution
Enfermedades Oculares+1
+ Hipermetropía
+ Miopía
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2007
Fecha en la que se inscribió al primer participante.The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 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 17 a 45 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: An eligible participant is one who: * Is between 17-45 years old and has full legal capacity to volunteer. * Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers. * Is willing and able to follow instructions and maintain the appointment schedule. * Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time) * Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction. * Has normal binocular vision (no strabismus, no amblyopia). * Has clear corneas and no active ocular disease. * Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS. * Has astigmatism less than or equal to -1.00DC. * Agrees to wear the study lenses on a daily wear basis. * Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study. Exclusion Criteria: A person is ineligible if he/she: * Has undergone corneal refractive surgery. * Is aphakic. * Has any active ocular disease. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that may affect ocular health. * Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study. * Is pregnant or lactating. * Is participating in any other clinical or research study. * Has a known clinically significant sensitivity to the contact lens care solutions used in the study. * Has ocular or systemic allergies that could adversely affect contact lens wear. * Currently wears lenses on a continuous or extended wear basis. * Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. * Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable. * Is a rigid lens wearer. * Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
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
Comparador ActivoObjetivos 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 una ubicación
Centre for Contact Lens Research, School of Optometry
Waterloo, CanadaAbrir Centre for Contact Lens Research, School of Optometry en Google Maps