Corneal and Conjunctival Sensitivity and Staining Study
Optifree RepleniSH Multipurpose Disinfecting Solution
+ ReNu Multiplus Multipurpose Solution
Maladies oculaires+1
+ Hypermétropie
+ Myopie
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 2007
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.50 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 17 à 45 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Centre for Contact Lens Research, School of Optometry
Waterloo, CanadaOuvrir Centre for Contact Lens Research, School of Optometry dans Google Maps