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El ensayo clínico NCT06708156 para Miopía, Progresión de la miopía está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression Fase III 606 Pediátrico Adolescentes
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El ensayo clínico NCT06708156 está diseñado para estudiar el tratamiento de Miopía, Progresión de la miopía. Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 15 de junio de 2024, con el objetivo de reclutar a 606 participantes. Dirigido por Oupushifang Pharmaceutical Technology Co., Ltd., se espera que finalice el 31 de diciembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 24 de diciembre de 2024.
Resumen
The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents.
Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atr...
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The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Progression of Myopia in Children and Adolescents in a Randomized, Double-blind, Placebo Parallel-controlled, Multicenter, Phase III Clinical Trial
Condiciones médicas
MiopíaProgresión de la miopíaOtros ID del estudio
- CTR20240786
- CTR20240786 (Identificador de registro) (National Medical Products Administration, NMPA)
Número del NCT
Inicio del estudio (real)
2024-06-15
Última actualización
2024-12-24
Fecha de finalización (estimada)
2027-12-31
Inscripción (prevista)
606
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Palabras clave
Myopia
Atropine
Atropine
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activoExperimental group (0.01% atropine sulfate eye drops) 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. | Atropine sulfate eye drops 0.01% Drug: 0.01% atropine sulfate eye drops Dosage form and strength: 0.01% (0.4 mL: 0.04 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. |
Comparador activoExperimental group (0.02% atropine sulfate eye drops) 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. | Atropine sulfate eye drops 0.02% Drug: 0.02% atropine sulfate eye drops Dosage form and strength: 0.02% (0.4 mL: 0.08 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. |
Comparador placeboControl group (placebo eye drops) 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. | Placebo eye drops Drug: placebo eye drops Dosage form and strength: 0.4 mL eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Effective change from baseline in equivalent spherical refraction at Week 96 visit | The inter-group difference in the value of change from baseline in equivalent spherical refraction after 0.01% or 0.02% atropine sulfate eye drops versus placebo under a cycloplegia condition at the Week 96 visit | At the Week 96 visit |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Effective change from baseline in eye axis length at 24 months | Value of change from baseline in eye axis length at 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 96 visit |
Effective change from baseline in refraction at 12 months | Change from baseline in refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) at 12 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 visit |
Effective change from baseline in ocular axis length at 12 months | Change from baseline in ocular axis length at 12 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 visit |
Progression of refraction ≤0.50 D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.50 D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Progression of refraction ≤0.75D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.75D at 12 months and 24 months and percentage (0.02% atropine vs placebo; 0.01% atropine vs placebo) | At the Week 48 and Week 96 visits |
Progression of refraction ≤1.00D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤1.00D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Progression of refraction >1.00D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) \>1.00D at 12 months and 24 months of dosing and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months | Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months of medication compared to control (0.02% atropine versus placebo; 0.01% atropine versus placebo) | At the Week 48 and Week 96 visits |
Change from baseline in other ocular morphologic measures at 12 months and 24 months | Change from baseline in other ocular morphologic measures (e.g., corneal curvature, vitreous chamber depth, choroidal thickness) at 12 months and 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño
Edad mínima
6 Years
Criterios de sexo
Todos
- The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written informed consent voluntarily.
- Patients with myopia aged 6 to 12 years, including cut-offs.
- The equivalent spherical refraction ranges from -1.00 D to -4.00 D (automatic optometry under a cycloplegia condition) in both myopia eyes at inclusion screening.
- The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
- The antimetropia (measured by equivalent spherical refraction) is < 2.00 D at inclusion screening.
- Able to comply with study requirements, attend all study visits (including telephone visits), and be willing to receive random grouping of atropine treatment or placebo.
- Allergic to this product or its excipients.
- Suffering from eye diseases that may affect vision (e.g. lens diseases such as cataracts, glaucoma, fundus macular disease, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc., manifest strabismus, nystagmus, ocular acute inflammatory disease), history of recurrent chronic ocular inflammation, or any other ocular pathology (e.g., angular stenosis, shallow anterior chamber).
- Intraocular pressure of either eye is > 21 mmHg or <10 mmHg at screening.
- Use of low-concentration (0.05% and below) atropine sulfate eye drops (including various in-hospital preparations, except for test drugs) and orthokeratology lenses (OK lenses) within 6 months before the screening.
- Use of other myopia control methods such as instruments (multifocal glasses, progressive multifocal glasses, etc.), medications (the use of cycloplegic agents for examinations such as optometry is allowed), and others (including traditional Chinese medicine, auricular acupuncture, massage, accommodative flippers, red light therapy instrument, etc.) within 3 months before screening.
- Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
- Systemic or topical use of drugs that affect the efficacy evaluation, such as anticholinergics: atropine, pirenzepine, etc., and cholinomimetics: pilocarpine, etc. within 1 week before screening.
- Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
- Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
- Heart rate sustained (more than 10 minutes) greater than 120 beats/min at screening (after 10 minutes of rest if the ECG shows a heart rate greater than 120 beats per minute, the ECG should be retested 10 minutes later. If the retest result below 120 beats/min, the screening is successful; If the retest result is still >120 beats/min, screening failed).
- Need for ocular use or systemic oral corticosteroids during the study. Intranasal, inhaled, topical cutaneous, intra-articular, perianal steroids, and short-term oral steroids (i.e., continuous use for < 2 weeks).
- Other conditions that are considered unsuitable by the investigator.
Oupushifang Pharmaceutical Technology Co., Ltd.- Seefunge Pharmaceutical Technology Co., Ltd.
- AUTEK China Inc.
Contactos centrales del estudio
Contacto: Liang Gao, 0086-15056564539, [email protected]
Contacto: Shaolong XUE, Dr., 0086-18565027687, [email protected]
25 Centros del estudio en 1 países
Anhui
Hefei Maternal and Child Health Hospital, Hefei, Anhui, China
Ruqin Zha, Contacto
Reclutando
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Liming Tao, Contacto
Reclutando
Xuancheng People's Hospital, Xuancheng, Anhui, China
Shenghua Dong, Contacto
Reclutando
Gansu
The Second Hospital of Lanzhou University, Lanzhou, Gansu, China
Wanna Ren, Contacto
Reclutando
Guangxi
Liuzhou People's Hospital, Liuchow, Guangxi, China
Xiaobo Wan, Contacto
Reclutando
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Qi Chen, Contacto
Reclutando
Guizhou
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Hao Gu, Contacto
Reclutando
The First People's Hospital of Zunyi, Zunyi, Guizhou, China
Wei Tan, Contacto
Reclutando
Heilongjiang
Daqingshi People's Hospital, Daqing, Heilongjiang, China
Xingmin Wang, Contacto
Reclutando
Henan
Kaifeng Central Hospital, Kaifeng, Henan, China
Hongmei Mu, Contacto
Reclutando
Hunan
The First Affiliated Hospital of University of South China, Hengyang, Hunan, China
Gang Tan, Contacto
Reclutando
Jiangsu
Huai'an First People's Hospital, Huai'an, Jiangsu, China
Chaopeng Li, Contacto
Reclutando
Jiangxi
Affiliated Eye Hospital of Nanchang University, Nanchang, Jiangxi, China
Hongfei Liao, Contacto
Reclutando
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaorong Wu, Contacto
Reclutando
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaolong Yin, Contacto
Reclutando
Shandong
Weifang Eye Hospital, Weifang, Shandong, China
Xianyong Sun, Contacto
Reclutando
Shanxi
Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
Yun Cui, Contacto
Reclutando
Shanxi Eye Hospital, Taiyuan, Shanxi, China
Junhong Li, Contacto
Reclutando
Xianyang Hospital of Yan'an University, Xianyang, Shanxi, China
Binke Yu, Contacto
Reclutando
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Lijun Shen, Contacto
Reclutando
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China
Feng Wu, Contacto, 0086-15910961255, [email protected]
Ningli Wang, Postdoctoral, Contacto
Reclutando
Peking University Third Hospital, Beijing, China
Yueguo Chen, Contacto
Reclutando
Chongqing Aier Eye Hospital, Chongqing, China
Yi Ren, Contacto
Reclutando
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital), Shanghai, China
Haidong Zou, Contacto
Wei Xu, Contacto
Reclutando
Tianjin Medical University Eye Hospital, Tianjin, China
Lin Liu, Contacto
Reclutando