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Die klinische Studie NCT06708156 für Myopie, Myopieprogression ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Wirksamkeit und Sicherheit von zwei niedrigkonzentrierten Atropinsulfat-Augentropfen (0,01%/0,02%) zur Verzögerung des Fortschreitens der pädiatrischen Myopie Phase 3 606 Jugendliche
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Die klinische Studie NCT06708156 untersucht Behandlung im Zusammenhang mit Myopie, Myopieprogression. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 15. Juni 2024. Es ist geplant, 606 Teilnehmer aufzunehmen. Durchgeführt von Oupushifang Pharmaceutical Technology Co., Ltd. wird der Abschluss für 31. Dezember 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. Dezember 2024 aktualisiert.
Kurzbeschreibung
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...
Mehr anzeigenOffizieller Titel
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
Erkrankungen
MyopieMyopieprogressionWeitere Studien-IDs
- CTR20240786
- CTR20240786 (Registerkennung) (National Medical Products Administration, NMPA)
NCT-Nummer
Studienbeginn (tatsächlich)
2024-06-15
Zuletzt aktualisiert
2024-12-24
Studienende (vorauss.)
2027-12-31
Geplante Rekrutierung
606
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Myopia
Atropine
Atropine
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Aktives VergleichspräparatExperimental 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. |
Aktives VergleichspräparatExperimental 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. |
Placebo-VergleichspräparatControl 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
6 Years
Zugelassene Geschlechter
Alle
- 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.
Zentrale Studienkontakte
Kontakt: Liang Gao, 0086-15056564539, [email protected]
Kontakt: Shaolong XUE, Dr., 0086-18565027687, [email protected]
25 Studienstandorte in 1 Ländern
Anhui
Hefei Maternal and Child Health Hospital, Hefei, Anhui, China
Ruqin Zha, Kontakt
Offene Rekrutierung
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Liming Tao, Kontakt
Offene Rekrutierung
Xuancheng People's Hospital, Xuancheng, Anhui, China
Shenghua Dong, Kontakt
Offene Rekrutierung
Gansu
The Second Hospital of Lanzhou University, Lanzhou, Gansu, China
Wanna Ren, Kontakt
Offene Rekrutierung
Guangxi
Liuzhou People's Hospital, Liuchow, Guangxi, China
Xiaobo Wan, Kontakt
Offene Rekrutierung
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Qi Chen, Kontakt
Offene Rekrutierung
Guizhou
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Hao Gu, Kontakt
Offene Rekrutierung
The First People's Hospital of Zunyi, Zunyi, Guizhou, China
Wei Tan, Kontakt
Offene Rekrutierung
Heilongjiang
Daqingshi People's Hospital, Daqing, Heilongjiang, China
Xingmin Wang, Kontakt
Offene Rekrutierung
Henan
Kaifeng Central Hospital, Kaifeng, Henan, China
Hongmei Mu, Kontakt
Offene Rekrutierung
Hunan
The First Affiliated Hospital of University of South China, Hengyang, Hunan, China
Gang Tan, Kontakt
Offene Rekrutierung
Jiangsu
Huai'an First People's Hospital, Huai'an, Jiangsu, China
Chaopeng Li, Kontakt
Offene Rekrutierung
Jiangxi
Affiliated Eye Hospital of Nanchang University, Nanchang, Jiangxi, China
Hongfei Liao, Kontakt
Offene Rekrutierung
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaorong Wu, Kontakt
Offene Rekrutierung
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaolong Yin, Kontakt
Offene Rekrutierung
Shandong
Weifang Eye Hospital, Weifang, Shandong, China
Xianyong Sun, Kontakt
Offene Rekrutierung
Shanxi
Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
Yun Cui, Kontakt
Offene Rekrutierung
Shanxi Eye Hospital, Taiyuan, Shanxi, China
Junhong Li, Kontakt
Offene Rekrutierung
Xianyang Hospital of Yan'an University, Xianyang, Shanxi, China
Binke Yu, Kontakt
Offene Rekrutierung
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Lijun Shen, Kontakt
Offene Rekrutierung
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China
Feng Wu, Kontakt, 0086-15910961255, [email protected]
Ningli Wang, Postdoctoral, Kontakt
Offene Rekrutierung
Peking University Third Hospital, Beijing, China
Yueguo Chen, Kontakt
Offene Rekrutierung
Chongqing Aier Eye Hospital, Chongqing, China
Yi Ren, Kontakt
Offene Rekrutierung
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital), Shanghai, China
Haidong Zou, Kontakt
Wei Xu, Kontakt
Offene Rekrutierung
Tianjin Medical University Eye Hospital, Tianjin, China
Lin Liu, Kontakt
Offene Rekrutierung