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

6. März 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

65

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

17 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Gerät: 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.
Andere Namen:
  • AIR OPTIX NIGHT & DAY AQUA
Gerät: Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Andere Namen:
  • Klare Pflege®
Aktiver Komparator: 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.
Gerät: Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Andere Namen:
  • Klare Pflege®
Gerät: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Andere Namen:
  • NIGHT & DAY®
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Leukocyte Population
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

CIBA VISION

Mitarbeiter

University of Waterloo

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2011

Primärer Abschluss (Tatsächlich)

1. Januar 2012

Studienabschluss (Tatsächlich)

1. Januar 2012

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2011

Zuerst gepostet (Schätzen)

23. Juni 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

8. März 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. März 2013

Zuletzt verifiziert

1. März 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • P-373-C-102

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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