- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01857102
Toric Eye Strain and Stability Study
18 juin 2018 mis à jour par: Johnson & Johnson Vision Care, Inc.
The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
159
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77204
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- The subject must have read, understand, and sign the statement of informed consent and receive a fully executed copy of the Informed Consent Form.
- The subject must appear able and willing to adhere to the instructions set forth in this protocol.
- The subject must be between 18 years and 45 years of age (inclusive).
- The subject must have best-corrected Snellen visual acuity of 20/30 or better in each eye.
- If the subject has ever worn contact lenses, the subject must be a current wearer of soft spherical contact lenses for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
- Subjective refraction must result in a vertex-corrected astigmatic contact lens prescription requiring at least -0.75 DC but not more than -1.75 DC cylindrical contact lens correction in each eye.
- Subjective refraction must result in a vertex-corrected spherical contact lens prescription between +0.25D to +4.00D or between-0.50D to -9.00D in each eye.
- The subject must not have the need for presbyopic correction (i.e., they must not be using as add in spectacles or wearing multifocal or monofocal contact lenses).
- The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
- The subject must have access to the internet throughout the day (either desktop and/or smartphone) and be willing to answer a web-based survey within 1 hour of receiving a text message based notification throughout the day for up to 8 days, throughout the study duration.
Exclusion Criteria:
- Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued)
- Any previous ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. greater than or equal to grade 3 finding of edema, corneal neovascularization, corneal staining, conjunctival injection, blepharitis/meibomian gland dysfunction) on the FDA classification scale or any other ocular abnormality that in the opinion of the investigator may contraindicate contact lens wear.
- Any ocular infection
- Current use of topical ophthalmic medications other than artificial tears/rewetting drops.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
- Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
- Employee of the investigational clinic (e.g. investigator, coordinator, technician)
- Subject does not have a wearable pair of spectacles.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: etafilcon A/etafilcon A for Astigmatism
Subjects were randomized to one of two sequences of lens wear.
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Soft contact lens to be worn in a daily wear, daily disposable modality for one week
Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week.
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Expérimental: etafilcon A for Astigmatism/etafilcon A
Subjects were randomized to one of two sequences of lens wear.
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Soft contact lens to be worn in a daily wear, daily disposable modality for one week
Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective Comfort Assessed by Electromyography(EMG)
Délai: 1 week
|
Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle.
The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit.
This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting.
The palpebral portion of this muscle closes the eyelids.
The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain.
The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording.
The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.
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1 week
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Visual Comfort
Délai: 1-week follow-up
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The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0.
The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life.
This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction.
An overall score is calculated by averaging the subscales.
The overall scores can take on values of 0 to 100.
Higher scores indicate better outcomes
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1-week follow-up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2013
Achèvement primaire (Réel)
1 juin 2014
Achèvement de l'étude (Réel)
1 juin 2014
Dates d'inscription aux études
Première soumission
8 mai 2013
Première soumission répondant aux critères de contrôle qualité
15 mai 2013
Première publication (Estimation)
20 mai 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 juin 2018
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR-5363
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