A study of 0.05%, 0.025%, 0.01% and 0.005% Atropine Eye Drops compared to eye drops without any efficient ingredients in European children suffering from progredient shortsightness, where neither the doctors nor the children or their parents know about the applied substance.
- Conditions
- Myopia progression in childrenTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2021-004884-29-DE
- Lead Sponsor
- Pharma Stulln GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 135
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
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.
20. Unreliability or lack of cooperation
21. History of any myopia treatment within 3 months before inclusion: e.g. DIMS glasses,
Orthokeratology contact lenses, multifocal contact lenses, atropine eye drops
22. Pregnancy
23. Other reasons why, in the opinion of the investigator, the subjects should not participate in the
study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary efficacy endpoint is the change of myopia determined by the spherical equivalent measured by autorefractor measurement with cycloplegia in the following 12 months after the beginning of low dose atropine treatment.<br><br>Primary efficacy variable is the difference of the spherical equivalent measured by autorefraction with cycloplegia after 12 months of low dose Atropine treatment and of autorefraction with cycloplegia at start of study.<br>;Main Objective: To evaluate the optimal dose of low-dose atropine eye drops compared to placebo for the inhibition of myopia progression in children;Secondary Objective: To evaluate anatomical and functional effects of low-dose atropine eye drops compared to placebo;Timepoint(s) of evaluation of this end point: Days 1, 15, 183, 365
- Secondary Outcome Measures
Name Time Method