EUCTR2021-004884-29-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Dose Finding Study of 0.05%, 0.025%, 0.01% and 0.005% Atropine Eye Drops to inhibit myopia progression in children in a European population
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male subjects and female subjects from 6 to 12 years of age. (female subjects who cannot become pregnant and female subjects of child bearing potential (after menarche) who use an highly effective contraceptive method or strategy (failure rate per year < 1%) according to the CTFG Guidance Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1, updated”; see Section 11.3).
- •2. Subjects showing myopia between =-1.0 and =-4.0 D (spherical equivalent as assessed by autorefraction under cycloplegia) and a progression of myopia within the past 12 months in at least one eye.
- •3. Parents or legal guardians who have been informed about the clinical study and have signed the informed consent form.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 135
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical Conditions
- •1. Anisometropia (SE) > |1.0| D
- •2. Corneal astigmatism (?TK) > |1.5| D
- •3. Best corrected visual acuity VADecimal< 1.0 (VAlogMAR > 0.0)
- •4. Pathological findings in the eyes, i.e. pathological myopia, corneal scars and pathologies in the
- •anterior or posterior segments of the eye
- •5. Known intolerances to atropine eye drops or known hypersensitivity to any of the other components
- •of the investigational product, allergies against eye drops
- •6. Presence of a contraindication for the treatment with atropine:
- •- Hypersensitivity to the active substance or to any of the excipients.
- •- Primary forms of glaucoma
- •- narrow-angle glaucoma
- •- rhinitis sicca
- •- Narrow-angel of anterior chamber
- •- Tachycardia, congestive heart failure, coronary stenoses
- •- Thyrotoxicosis, hyperthyroidism
- •- Mechanical obstruction of the gastrointestinal tract
- •- Paralytic ileus
- •- Megacolon
- •- Obstructive urinary tract diseases, e.g. prostatic hypertrophy with residual urine formation
- •- Myasthenia gravis
- •- Acute pulmonary edema
- •- Pregnancy toxicosis
- •- Spastic paralysis
- •7. Down syndrome
- •Concomitant Therapy within the last 3 Months prior to Enrollment
- •8. Any ocular therapy other than the IMP, except for antibiotic or anti-allergic eye drops
- •9. Treatments with
- •- Monoamine oxidase (MAO) inhibitor therapy
- •- Antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and
- •mianserine)
- •10. Treatment with sympathomimetics
- •11. Treatment with drugs that may increase the anticholinergic effect of atropine:
- •- Amantadine
- •- Anti-arrhymics such as chinidine, procainamide and disopyramide
- •- Dopamine-antagonists such as metoclopramide
- •- Antihistaminics
- •- Certain anti-Parkinsonian drugs (except dopamine receptor agonists)
- •- Neuroleptics
- •12. Treatment with pilocarpin and physostigmine containing drugs
- •13. Treatment with digoxine and nitrofurantoin
- •14. Treatment with phenothiazine
- •15. Treatment with levodopa
- •Prior/Concurrent Clinical Study Experience
- •16. Enrolment in another clinical study within the last 4 weeks or during enrolment in this study
- •Other Exclusion Criteria
- •17. East Asian or African origin
- •18. Previous or current alcohol or drug abuse
- •19. Mental or emotional instability of the subject, parents or legal guardians that might jeopardize the
- •validity of the informed consent or the compliance with the study procedures.
- 另有 5 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseEUCTR2020-000105-92-ESovartis Farmacéutica S.A.75
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisRheumatoid ArthritisEUCTR2004-002157-30-FITakeda Europe R&D Centre Ltd. (TEuR&D)400
进行中（未招募）
1 期
Study to determine the dose CCX140-B and to evaluate the its safety and efficacy of in Subjects with Focal Segmental Glomerulosclerosis (FSGS)EUCTR2017-003021-15-FRChemoCentryx, Inc.40
进行中（未招募）
1 期
A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseEUCTR2020-000105-92-LTovartis Pharma AG75
进行中（未招募）
1 期
A controlled study to evaluate the safety and efficacy of the study drug, CCX140-B, in subjects with Focal Segmental Glomerulosclerosis (a type of glomerular disease)Focal Segmental Glomerulosclerosis (FSGS)MedDRA version: 20.0Level: PTClassification code 10067757Term: Focal segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2017-003021-15-PLChemoCentryx, Inc.40