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Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children (EVASION)

2 de julho de 2026 atualizado por: Essilor International

Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children

The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and < 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:

Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?

Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?

Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.

Participants will:

  • Wear the study spectacles for 2 weeks
  • Respond to questionnaires 4 days after dispensing and at 2 weeks
  • Visit Essilor R&D Centre for screening, dispensing and follow up sessions

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

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.

Contato de estudo

Estude backup de contato

  • Nome: Thomas Boudenne

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

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Volunteer participant who is willing and able to comply with all scheduled study visits.
  • Informed consent of parent/guardian and assent of participant.
  • Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
  • Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
  • Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
  • Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
  • Be in good general health, based on the participant and the parent's/guardian's knowledge.

Exclusion Criteria:

  • History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
  • Strabismus by cover test at near or distance wearing correction.
  • History and presence of amblyopia.
  • Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
  • Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
  • History of ocular injury or surgery.
  • Participation in any clinical study within 30 days of the Baseline visit.
  • Sibling of existing participant of this study
  • Study participants deemed inappropriate for the study by the investigator.
  • The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.

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: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Test
Test Lens
Dispositivo: HADAL Spectacle Lenses
Dispense to Test group for 2 weeks
Comparador Ativo: Control
Control Lens
Dispositivo: Stellest® Spectacle Lenses
Dispense to Control group for 2 weeks

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Successful Adaptation Rate Within 1 Week After Dispensing
Prazo: Within 1 week post dispensing

Proportion of children who meet all of the following criteria at the 1-week visit:

  1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire
  2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the 4-day visit, as assessed through the symptom checklist in the study questionnaire
  3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the 1-week visit.

Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin.
Within 1 week post dispensing

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Successful Adaptation Rates at Early and Later Timepoints
Prazo: 4 days and 2 weeks post-dispensing

Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing:

  1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire
  2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the previous visit, as assessed through the symptom checklist in the study questionnaire
  3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the respective visit

Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints.
4 days and 2 weeks post-dispensing
Average daily and weekly wearing time
Prazo: Assessed at Day 4 and Week 2 post-dispensing
Mean daily wearing time (hours/day) and total weekly wearing time (hours/week) of the assigned study spectacles will be compared between the test and control groups, based on participant/parent-reported wear time.
Assessed at Day 4 and Week 2 post-dispensing
Activity-specific visual comfort
Prazo: 4 days and 2 weeks post-dispensing
Participant-reported visual comfort during daily activities (including far vision, intermediate vision, near vision with and without digital devices, and overall vision) will be evaluated using the specific comfort subscale items from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual comfort items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded comfort questions are reverse-coded prior to analysis so that all values are directionally aligned. The subscale score is calculated as the mean of these items, yielding a minimum value of 1 and a maximum value of 4, where a higher score indicates a better outcome (greater visual comfort during daily activities). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
4 days and 2 weeks post-dispensing
Overall satisfaction
Prazo: 4 days and 2 weeks post-dispensing
Overall satisfaction with the study spectacles will be evaluated using the satisfaction subscale items (e.g., "I hate wearing the new spectacles" and "I like my new spectacles") from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded items are reverse-coded during data analysis. Subscale scores are calculated as the mean of the items, ranging from a minimum value of 1 to a maximum value of 4, where higher scores indicate a better outcome (higher satisfaction with the spectacles). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
4 days and 2 weeks post-dispensing
High-contrast visual acuity (distance and near)
Prazo: At dispensing (baseline) and 2 weeks post-dispensing
Monocular and binocular high-contrast visual acuity at distance and near, measured while wearing study spectacles, will be compared between the test and control groups.
At dispensing (baseline) and 2 weeks post-dispensing

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Essilor International

Investigadores

  • Investigador principal: Sheron Quak, Essilor R&D Centre Singapore

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 (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

17 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de julho de 2026

Primeira postagem (Real)

6 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • WS10506
  • PIEC/2026/015 (Identificador de registro: Parkway Independent Ethics Committee)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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