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

2 de julio de 2026 actualizado 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Thomas Boudenne

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Test
Test Lens
Dispositivo: HADAL Spectacle Lenses
Dispense to Test group for 2 weeks
Comparador activo: Control
Control Lens
Dispositivo: Stellest® Spectacle Lenses
Dispense to Control group for 2 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Successful Adaptation Rate Within 1 Week After Dispensing
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Successful Adaptation Rates at Early and Later Timepoints
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Essilor International

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de octubre de 2026

Finalización del estudio (Estimado)

1 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de julio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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