رادار التجارب AI | ||
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حالة التجربة السريرية NCT06708156 لـ قصر النظر، تقدم قصر النظر هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression المرحلة الثالثة ٦٠٦ طب الأطفال المراهقون
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06708156 مصممة لدراسة علاج لـقصر النظر، تقدم قصر النظر. إنها تجربة تدخُّلية من المرحلة الثالثة وهي يقبل مشاركين. بدأت في ٩ ذو الحجة ١٤٤٥ هـ مع خطة لتجنيد ٦٠٦ مشاركًا. تقودها Oupushifang Pharmaceutical Technology Co., Ltd.، ومن المتوقع اكتمالها بحلول ٣ شعبان ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٣ جمادى الآخرة ١٤٤٦ هـ.
الملخص
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...
عرض المزيدالعنوان الرسمي
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
الحالات الطبية
قصر النظرتقدم قصر النظرمعرّفات دراسة أخرى
- CTR20240786
- CTR20240786 (معرف السجل) (National Medical Products Administration, NMPA)
NCT معرّف
تاريخ البدء (فعلي)
2024-06-15
آخر تحديث مُنشور
2024-12-24
تاريخ الاكتمال (المقدر)
2027-12-31
عدد المشاركين المخطط لهم
٦٠٦
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثالثة
الحالة
يقبل مشاركين
الكلمات الرئيسية
Myopia
Atropine
Atropine
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
تصميم متقاطع
التعمية
رباعي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطExperimental 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. |
مقارن نشطExperimental 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. |
مقارن بالدواء الوهميControl 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. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل
العمر الأدنى للدراسة
6 Years
الجنس المؤهل
الكل
- 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.
جهة اتصال مركزية للدراسة
جهة اتصال: Liang Gao, 0086-15056564539, [email protected]
جهة اتصال: Shaolong XUE, Dr., 0086-18565027687, [email protected]
25 مواقع الدراسة في 1 بلدان
Anhui
Hefei Maternal and Child Health Hospital, Hefei, Anhui, China
Ruqin Zha, جهة اتصال
يقبل مشاركين
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Liming Tao, جهة اتصال
يقبل مشاركين
Xuancheng People's Hospital, Xuancheng, Anhui, China
Shenghua Dong, جهة اتصال
يقبل مشاركين
Gansu
The Second Hospital of Lanzhou University, Lanzhou, Gansu, China
Wanna Ren, جهة اتصال
يقبل مشاركين
Guangxi
Liuzhou People's Hospital, Liuchow, Guangxi, China
Xiaobo Wan, جهة اتصال
يقبل مشاركين
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Qi Chen, جهة اتصال
يقبل مشاركين
Guizhou
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Hao Gu, جهة اتصال
يقبل مشاركين
The First People's Hospital of Zunyi, Zunyi, Guizhou, China
Wei Tan, جهة اتصال
يقبل مشاركين
Heilongjiang
Daqingshi People's Hospital, Daqing, Heilongjiang, China
Xingmin Wang, جهة اتصال
يقبل مشاركين
Henan
Kaifeng Central Hospital, Kaifeng, Henan, China
Hongmei Mu, جهة اتصال
يقبل مشاركين
Hunan
The First Affiliated Hospital of University of South China, Hengyang, Hunan, China
Gang Tan, جهة اتصال
يقبل مشاركين
Jiangsu
Huai'an First People's Hospital, Huai'an, Jiangsu, China
Chaopeng Li, جهة اتصال
يقبل مشاركين
Jiangxi
Affiliated Eye Hospital of Nanchang University, Nanchang, Jiangxi, China
Hongfei Liao, جهة اتصال
يقبل مشاركين
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaorong Wu, جهة اتصال
يقبل مشاركين
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaolong Yin, جهة اتصال
يقبل مشاركين
Shandong
Weifang Eye Hospital, Weifang, Shandong, China
Xianyong Sun, جهة اتصال
يقبل مشاركين
Shanxi
Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
Yun Cui, جهة اتصال
يقبل مشاركين
Shanxi Eye Hospital, Taiyuan, Shanxi, China
Junhong Li, جهة اتصال
يقبل مشاركين
Xianyang Hospital of Yan'an University, Xianyang, Shanxi, China
Binke Yu, جهة اتصال
يقبل مشاركين
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Lijun Shen, جهة اتصال
يقبل مشاركين
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China
Feng Wu, جهة اتصال, 0086-15910961255, [email protected]
Ningli Wang, Postdoctoral, جهة اتصال
يقبل مشاركين
Peking University Third Hospital, Beijing, China
Yueguo Chen, جهة اتصال
يقبل مشاركين
Chongqing Aier Eye Hospital, Chongqing, China
Yi Ren, جهة اتصال
يقبل مشاركين
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital), Shanghai, China
Haidong Zou, جهة اتصال
Wei Xu, جهة اتصال
يقبل مشاركين
Tianjin Medical University Eye Hospital, Tianjin, China
Lin Liu, جهة اتصال
يقبل مشاركين