Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Clinical and Laboratory Evaluation of 3 Contact Lenses With 4 Contact Lens Solutions

18 juin 2018 mis à jour par: Johnson & Johnson Vision Care, Inc.

Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions

The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

269

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

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada
        • University of Waterloo Centre for Contact Lens Research School of Optometry
  • Royaume-Uni
    • Lancashire
      • Manchester, Lancashire, Royaume-Uni
        • University of Manchester, Department of Optometry & Neuroscience
  • États-Unis
    • Texas
      • Houston, Texas, États-Unis, 77204
        • University of Houston College of Optometry

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 69 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instruction set forth in this clinical protocol.
  3. The subject must be between 18 and 69 years of age.
  4. The subject must be willing to participate in a 9-month study.
  5. The subject must require a visual correction in both eyes.
  6. Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
  7. The subject must have best-corrected visual acuity of 0.20 or better in each eye.
  8. The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
  9. The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
  10. The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.

Exclusion Criteria:

  1. 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).
  2. Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
  3. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
  4. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
  5. Any active ocular infection.
  6. Current use of topical ophthalmic medications.
  7. History of binocular vision abnormality or strabismus.
  8. More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
  9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
  10. History of severe allergic reaction or anaphylaxis.
  11. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
  12. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
  13. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

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: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
Autre: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Autres noms:
  • Revitalens
Autre: Solution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Pure Moist
Autre: Solution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Biotrue
Autre: Solution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Clear Care
Autre: Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
Autre: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Autres noms:
  • Revitalens
Autre: Solution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Pure Moist
Autre: Solution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Biotrue
Autre: Solution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Clear Care
Autre: Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
Autre: Solution 1 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
Autres noms:
  • Revitalens
Autre: Solution 2 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Pure Moist
Autre: Solution 3 (Test)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Biotrue
Autre: Solution 4 (Control)
Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
Autres noms:
  • Clear Care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Comfort Score (Senofilcon A Lens)
Délai: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
2-Week Follow-up
Overall Comfort Score (Galyfilcon A Lens)
Délai: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
2-Week Follow-up
Overall Comfort Score (Etafilcon A Lens)
Délai: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
2-Week Follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Johnson & Johnson Vision Care, Inc.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 (Réel)

1 février 2013

Achèvement primaire (Réel)

1 février 2014

Achèvement de l'étude (Réel)

1 février 2014

Dates d'inscription aux études

Première soumission

11 février 2013

Première soumission répondant aux critères de contrôle qualité

11 février 2013

Première publication (Estimation)

15 février 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 octobre 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CR-5230

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner