Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%
Olopatadine hydrochloride ophthalmic solution, 0.2%
Enfermedades Conjuntivales+4
+ Conjuntivitis
+ Enfermedades Oculares
Resumen
Fecha de inicio: 1 de septiembre de 2012
Fecha en la que se inscribió al primer participante.Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 17 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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: Read, sign, and date an Ethics Committee reviewed and approved informed consent form. Females of childbearing potential who: Are not breast-feeding; Do not intend to become pregnant for the duration of the study; Are using adequate birth control methods and agree to continue for the duration of the study. Able to read, understand and answer questions by investigator. Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator. History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator. Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction. Ocular health within normal limits as determined by the investigator. No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study. Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Contraindications or hypersensitivity to the use of the test article or its components. Inability or unwillingness to follow all study instructions and complete study visits as required. Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit. Ocular trauma within 6 months prior to Visit 1 in either eye. Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study. Presumed or actual ocular infection within 30 days prior to Visit 1. Any severe or serious ocular condition or significant illness. Any abnormal slit-lamp findings at the time of the Screening Visit. Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study. Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period. Use of topical or systemic ocular medications requiring longer than a two-week washout period. Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study. Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures. Other protocol-defined exclusion criteria may apply.
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
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