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Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (CORNWALL)

6 mars 2013 mis à jour par: CIBA VISION

Polymorphonuclear Leukocyte Response During Overnight Lens Wear

The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep. The results from contact lens wearers were compared with the results from non-contact lens wearers.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers. Tear samples were collected via a binocular eye-wash. The samples were processed, and a cell count was performed using a hemacytometer. Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).

Type d'étude

Interventionnel

Inscription (Réel)

65

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, N2L 3G1
        • University of Waterloo Centre for Contact Lens Research

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

17 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • 17 years of age or older.
  • Ocular examination in the last two years.
  • Has up-to-date spectacles.

  • Falls into one of the following three categories:

    • Adapted wearer of Lotrafilcon A contact lenses
    • Adapted wearer of Lotrafilcon B contact lenses
    • Does not wear contact lenses
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Ocular disease
  • Systemic or topical medications that may affect ocular health.
  • Known sensitivity to diagnostic pharmaceuticals used in study.
  • Uses artificial tears and/or rewetting drops.
  • Wears contact lenses on an overnight basis for more than one night per week.
  • Other protocol-defined exclusion criteria may apply.

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: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Lotrafilcon A
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
Dispositif: Lotrafilcon A contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
Autres noms:
  • AIR OPTIX NIGHT & DAY AQUA
Dispositif: Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Autres noms:
  • Clear Care®
Comparateur actif: Lotrafilcon B
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
Dispositif: Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Autres noms:
  • Clear Care®
Dispositif: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Autres noms:
  • NIGHT & DAY®
Aucune intervention: No lens wear
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Leukocyte Population
Délai: Week 5
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.
Week 5
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
Délai: Week 5
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.
Week 5
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
Délai: Week 5
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).
Week 5
Change From Week 1 in Leukocyte Population at Week 5
Délai: Week 1, Week 5
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
Week 1, Week 5
Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
Délai: Week 1, Week 5
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
Week 1, Week 5
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
Délai: Week 1, Week 5
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
Week 1, Week 5

Collaborateurs et enquêteurs

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

Parrainer

CIBA VISION

Collaborateurs

University of Waterloo

Les enquêteurs

  • Chercheur principal: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo

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 mai 2011

Achèvement primaire (Réel)

1 janvier 2012

Achèvement de l'étude (Réel)

1 janvier 2012

Dates d'inscription aux études

Première soumission

9 juin 2011

Première soumission répondant aux critères de contrôle qualité

22 juin 2011

Première publication (Estimation)

23 juin 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 mars 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mars 2013

Dernière vérification

1 mars 2013

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • P-373-C-102

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 .

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