Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (CORNWALL)
6 de março de 2013 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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).
Tipo de estudo
Intervencional
Inscrição (Real)
65
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ontario
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Waterloo, Ontario, Canadá, N2L 3G1
- University of Waterloo Centre for Contact Lens Research
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
17 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
Outros nomes:
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Outros nomes:
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Comparador Ativo: 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.
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Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Outros nomes:
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Outros nomes:
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Leukocyte Population
Prazo: 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)
Prazo: 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.
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)
Prazo: 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
Prazo: 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
Prazo: 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) 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.
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Week 1, Week 5
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Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2011
Conclusão Primária (Real)
1 de janeiro de 2012
Conclusão do estudo (Real)
1 de janeiro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de junho de 2011
Primeira postagem (Estimativa)
23 de junho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de março de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de março de 2013
Última verificação
1 de março de 2013
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- P-373-C-102
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