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NCT03911271: APP

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

Completed Phase 2 Results posted Last updated 29 June 2025
What this trial tests

Phase 2 trial testing 0.1% atropine and 0.01% atropine in Myopia in 97 participants. Completed in 23 April 2024.

Timeline
30 May 2019
Primary endpoint
23 April 2024
23 April 2024

Quick facts

Lead sponsorLine Kessel
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment97
Start date30 May 2019
Primary completion23 April 2024
Estimated completion23 April 2024
Sites3 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Line Kessel — full company profile →

Who can join

Adults 6 to 12, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Axial Length at 36 Months Primary · 36 months

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

GroupValue95% CI
Loading Dose25.2825.06 – 25.50
Low Dose25.2525.03 – 25.47
Placebo25.3325.11 – 25.56
Spherical Equivalent at 36 Months Primary · 36 months

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

GroupValue95% CI
Loading Dose-4.45-4.84 – -4.06
Low Dose-4.26-4.65 – -3.87
Placebo-4.43-4.83 – -4.03
Adverse Events Secondary · 36 months

Total individual adverse events per interventional arm

GroupValue95% CI
Loading Dose104
Low Dose22
Placebo18
Change in Choroidal Thickness From Baseline to 36 Months Secondary · 36 months

Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)

GroupValue95% CI
Loading Dose2-11 – 15
Low Dose7-3 – 17
Placebo3-8 – 14

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment to three years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Loading Dose
Serious: 0/33 (0%)
Deaths: 0/33
Low Dose
Serious: 0/32 (0%)
Deaths: 0/32
Placebo
Serious: 3/32 (9%)
Deaths: 0/32

Serious adverse events (3 terms)

ReactionSystemLoading DoseLow DosePlacebo
LymphadenopathyImmune system disorders
Suspicion of meningitisNervous system disorders
AppendicitisGastrointestinal disorders
Other adverse events (6 terms — click to expand)

ReactionSystemLoading DoseLow DosePlacebo
Blurred near visionEye disorders
PhotophobiaEye disorders
Dilated pupilsEye disorders
OtherEye disorders
Eye redness/irritationEye disorders
Blurred distance visionEye disorders

Most-reported serious reactions: Lymphadenopathy, Suspicion of meningitis, Appendicitis.

Data from ClinicalTrials.gov NCT03911271 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for myopia control in children: a living systematic review and network meta-analysis.
    Lawrenson JG, Shah R, Huntjens B, Downie LE, et al · · 2023 · cited 117× · PMID 36809645 · DOI 10.1002/14651858.cd014758.pub2
  2. 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.
    Hansen NC, Hvid-Hansen A, Møller F, Bek T, et al · · 2023 · cited 16× · PMID 37904082 · DOI 10.1186/s12886-023-03177-9
  3. Myopia Control with Low-Dose Atropine in European Children: Six-Month Results from a Randomized, Double-Masked, Placebo-Controlled, Multicenter Study.
    Hvid-Hansen A, Jacobsen N, Møller F, Bek T, et al · · 2023 · cited 9× · PMID 36836559 · DOI 10.3390/jpm13020325
  4. Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial.
    Hansen NC, Hvid-Hansen A, Møller F, Bek T, et al · · 2024 · cited 8× · PMID 38392608 · DOI 10.3390/jpm14020175
  5. Low-Dose Atropine Induces Changes in Ocular Biometrics in Myopic Children: Exploring Temporal Changes by Linear Mixed Models and Contribution to Treatment Effect by Mediation Analyses.
    Hvid-Hansen A, Jacobsen N, Hjortdal J, Møller F, et al · · 2023 · cited 4× · PMID 36836139 · DOI 10.3390/jcm12041605
  6. 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.
    Hansen NC, Hvid-Hansen A, Bek T, Møller F, et al · · 2024 · cited 3× · PMID 39422837 · DOI 10.1007/s40123-024-01051-5
  7. 3-year results of 0.01% and 0.1% loading dose atropine treatment including washout in Danish children with myopia: a placebo-controlled, randomised clinical trial.
    Hansen N, Hvid-Hansen A, Møller F, Bek T, et al · · 2025 · cited 2× · PMID 40122578 · DOI 10.1136/bjo-2024-326918
  8. Reproducibility of Mesopic and Photopic Pupil Sizes in Myopic Children Using a Dedicated Pupillometer with Human-Assisted or Automated Reading.
    Hvid-Hansen A, Bækgaard P, Jacobsen N, Hjortdal J, et al · · 2023 · PMID 36836507 · DOI 10.3390/jpm13020273

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