Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

NCT03911271 | Completed Phase 2 Results DMC

• 1 other identifier: Line Kessel, RH-Glostrup
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 3

Brief Summary

Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Axial Length at 36 Months

  Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700

  36 months

• Spherical Equivalent at 36 Months

  Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction

  36 months

Secondary Outcomes (2)

• Adverse Events

  36 months

• Change in Choroidal Thickness From Baseline to 36 Months

  36 months

Study Arms (3)

Loading dose

EXPERIMENTAL

In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Drug: 0.1% atropine and 0.01% atropine

Low dose

EXPERIMENTAL

In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Drug: 0.01% atropine

Placebo

PLACEBO COMPARATOR

In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Drug: 0.9% Sodium-chloride

Interventions

0.1% atropine and 0.01% atropine DRUG

0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months

Also known as: Loading dose

Loading dose

0.01% atropine DRUG

0.01% atropine for 24 months

Also known as: Low-dose

Low dose

0.9% Sodium-chloride DRUG

Placebo for 24 months

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged ≥6-\<9 years: myopia ≤-1 (spherical power) in at least one eye
• Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye
• Cylinder less than 1.5 diopters

You may not qualify if:

• Myopia related to retinal dystrophies
• Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
• Other ocular pathology (e.g., amblyopia, strabismus)
• Previous eye surgery
• Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
• Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
• Non-compliance to eye examinations
• Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays

Sponsors & Collaborators

• Line Kessel: lead
• Aarhus University Hospital: collaborator
• Vejle Hospital: collaborator

Study Sites (3)

Department of Ophthalmology, Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

Department of Ophthalmology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Publications (2)

• Hansen NC, Hvid-Hansen A, Bek T, Moller F, Jacobsen N, Kessel L. The Macular Choroidal Thickness in Danish Children with Myopia After Two-Year Low-Dose Atropine and One-Year Wash-Out: A Placebo-Controlled, Randomized Clinical Trial. Ophthalmol Ther. 2024 Dec;13(12):3111-3122. doi: 10.1007/s40123-024-01051-5. Epub 2024 Oct 18.

  PMID: 39422837 DERIVED

• Hansen NC, Hvid-Hansen A, Moller F, Bek T, Larsen DA, Jacobsen N, Kessel L. Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety. BMC Ophthalmol. 2023 Oct 30;23(1):438. doi: 10.1186/s12886-023-03177-9.

  PMID: 37904082 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Contraceptives, Oral; Sodium Chloride

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Niklas Cyril Hansen MD-PhD
• Organization: Rigshospitalet-Glostrup

niklas.cyril.hansen@regionh.dk

+45 31433244

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 11, 2019
• Study Start: May 30, 2019
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 29, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Locations

DK (3)