Low-dose AtropIne for Myopia control in children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical Center - University Of Freiburg

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

29 Sep 2021 → ongoing

Decision date (initial)

2024-10-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Deutsche Forschungsgemeinschaft (DFG)

External identifiers

EU CT number

2024-513091-17-00

EudraCT number

2020-001575-33

ClinicalTrials.gov

NCT03865160

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Therapy, Safety

The primary objective is to demonstrate superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control in children of Caucasian origin, measured as change of cycloplegic refraction/year [diopter per year (D/year)] after one year of treatment.

Secondary objectives 5

1. Compare atropine 0.02% and placebo with respect to axial eye length increase/year [mm/year]
2. Visual acuity at distance and at near
3. Pupil size
4. Accommodation
5. Safety regarding ocular and systemic side effects

Conditions and MedDRA coding

Progressive myopia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
2. Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
3. Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
4. Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion criteria 20

1. Asian or African origin
2. Abnormal binocularity
3. Strabismus
4. Astigmatism >1.5 D
5. Anisometropia >1.5 D
6. History of amblyopia
7. Corrected visual acuity in any eye <0.63
8. Any acquired or developmental organic eye disease
9. Premature birth
10. Any known systemic metabolic disease or chromosomal anomaly
11. Previous use of any kind of contact lenses
12. Previous use of atropine eye drops
13. Epilepsy
14. Known hypersensitivity to the active substances or any of the excipients
15. Participation in any other interventional clinical trial within the last 30 days before the start of this trial
16. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
17. Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
18. Caution and pediatric counselling shall be assured if any of the following conditions are present according to the Summary of Product Characteristics (SmPC): Cardiac insufficiency, arrhythmia, coronary stenosis, hyperthyroidism, stomach or bowel stenosis, bowel paralysis, megacolon, muscle weakness, lung edema, hypersensitivity to atropine, spastic paralysis
19. Parents or children with poor understanding of the German language
20. Person who is in a relationship of dependence/employment with the sponsor or the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of cycloplegic refraction/year [D/year] after 1 year of treatment.

Secondary endpoints 2

1. Axial eye length change/year [mm/year] after 1 year.
2. Categorized rate of change in refraction and eye length after 1 year.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical Center - University Of Freiburg

Sponsor organisation

Medical Center - University Of Freiburg

Address

Breisacher Strasse 153, Mooswald Mooswald

City

Freiburg Im Breisgau

Postcode

79110

Country

Germany

Scientific contact point

Organisation

Medical Center - University Of Freiburg

Contact name

Coordinating Investigator

Public contact point

Organisation

Medical Center - University Of Freiburg

Contact name

Coordinating Investigator

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications