Myopia progression in children
Conditions
Interventions
Product Name: Atropine 0.005% eye drops, solution in single-dose container
Product Code: AT005
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: ATROPINE SULFATE
C
Sponsors
Pharma Stulln GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical Conditions 1. Anisometropia (SE) > |1.0| D 2. Corneal astigmatism (?TK) > |1.5| D 3. Best corrected visual acuity VADecimal 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are the changes in - Axial eye growth - Anterior chamber depth - IOL-power for Spheris 209 - Lens thickness - Pupil size under photopic and scotopic conditions - Accommodation - Best corrected visual acuity and distance corrected near visual acuity - Atropine effects as a function of iris pigmentation in the course of 12 months of low dose Atropine treatment. The secondary efficacy variables are the differences (measurement after 12 months of low dose Atropine treatment minus measurement at start of study) of - Axial eye growth - Anterior chamber depth - IOL-power for Spheris 209 - Lens thickness - Pupil size under photopic and scotopic conditions - Accommodation - Best corrected visual acuity and distance corrected near visual acuity - Atropine effects as a function of iris pigmentation Safety: Change from Baseline to Day 365 in: - IOP - Appearance of the macula Incidence of - Local adverse drug reactions - Systemic adverse drug reactions as assessed by the subject/caregiver. Incidence of adverse events assessed by investigator;Timepoint(s) of evaluation of this end point: Days 1, 15, 183, 365 | — |
Countries
Germany
Contacts
Public ContactJohanna Nikulka-Stark
Winicker Norimed GmbH
Outcome results
None listed