Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (CORNWALL)
6. mars 2013 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
65
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Ontario
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Waterloo, Ontario, Canada, N2L 3G1
- University of Waterloo Centre for Contact Lens Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
17 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv 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.
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Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
Andre navn:
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Andre navn:
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Aktiv 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.
|
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Andre navn:
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Andre navn:
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Leukocyte Population
Tidsramme: Week 5
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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.
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Week 5
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Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
Tidsramme: 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.
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Week 5
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Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
Tidsramme: Week 5
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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).
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Week 5
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Change From Week 1 in Leukocyte Population at Week 5
Tidsramme: Week 1, Week 5
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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.
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Week 1, Week 5
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Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
Tidsramme: 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
Tidsramme: 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.
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Week 1, Week 5
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2011
Primær fullføring (Faktiske)
1. januar 2012
Studiet fullført (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først innsendt
9. juni 2011
Først innsendt som oppfylte QC-kriteriene
22. juni 2011
Først lagt ut (Anslag)
23. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. mars 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mars 2013
Sist bekreftet
1. mars 2013
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- P-373-C-102
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .