Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
Test lens
+ control lens
Maladies oculaires
+ Myopie
+ Erreurs de Réfraction
Étude thérapeutique
Résumé
Date de début de l'étude : 18 avril 2018
Date à laquelle le premier participant a commencé l'étude.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.
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.77 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 18 à 35 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs 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 4 sites
Golden Optometric Group
Whittier, United StatesGolden Vision
Sarasota, United StatesNittany Eye Associates
State College, United States