MyopiaPhase 2APPNCT03911271
Low-dose Atropine for the Prevention of Myopia Progression in Danish Children
A Phase 2 study testing 0.1% atropine and 0.01% atropine, 0.01% atropine and 0.9% Sodium-chloride in people with Myopia, run by Line Kessel at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- 0.1% atropine and 0.01% atropine, 0.01% atropine and 0.9% Sodium-chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 3 sitesDenmark
- Study dates
- 30 May 2019to 23 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Ophthalmology, Aarhus University Hospital
Aarhus, DK-8000
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, DK-2600
Department of Ophthalmology, Vejle Hospital
Vejle, DK-7100
About this study
Official title: Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo
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.
Read the detailed description
The main hypotheses tested in this study are:
- 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children.
- 0.01% atropine one drop nightly is safe and with no significant side effects.
- A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine.
- 0.1% atropine one drop nightly is safe and has tolerable side effects.
- The rebound effect after stopping both atropine regimens is limited.
- Choroidal thickness is a predictor for the progression of childhood myopia.
- Conditions
- Myopia
- Being tested
- 0.1% atropine and 0.01% atropine, 0.01% atropine, 0.9% Sodium-chloride
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% atropine and 0.01% atropineDrug
Also called Loading dose
0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
0.01% atropineDrug
Also called Low-dose
0.01% atropine for 24 months
0.9% Sodium-chlorideDrug
Also called Placebo
Placebo for 24 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: 0.9% Sodium-chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length at 36 Months
Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700
Measured: 36 months
Spherical Equivalent at 36 Months
Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction
Measured: 36 months
Secondary outcomes (2)
Adverse Events
Total individual adverse events per interventional arm
Measured: 36 months
Change in Choroidal Thickness From Baseline to 36 Months
Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start30 May 2019
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Line Kessel
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital
- Responsible party
- Sponsor-investigator, Line Kessel, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911271
- Sponsor's protocol ID
- Line Kessel, RH-Glostrup
- Acronym
- APP
- Status last verified
- Jun 2025
- First submitted
- 2 Apr 2019
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hansen NC, Behrens CM, Hvid-Hansen A, Hamann S, Kessel L. Peripapillary hyperreflective ovoid mass-like structure (PHOMS): prevalence, risk factors, and development over time in Danish myopic children. J AAPOS. 2024 Dec;28(6):104034. doi: 10.1016/j.jaapos.2024.104034. Epub 2024 Nov 8.
PubMed 39522589Hansen 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.
PubMed 39422837Hansen 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.
PubMed 37904082
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo
- ClinicalTrials.gov ID
- NCT03911271
- Acronym / sponsor ID
- APP / Line Kessel, RH-Glostrup
- Conditions
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Line KesselUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital
- Study start
- 30 May 2019 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main hypotheses tested in this study are:
- 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children.
- 0.01% atropine one drop nightly is safe and with no significant side effects.
- A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine.
- 0.1% atropine one drop nightly is safe and has tolerable side effects.
- The rebound effect after stopping both atropine regimens is limited.
- Choroidal thickness is a predictor for the progression of childhood myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Loading dose | Experimental | Drug: 0.1% atropine and 0.01% atropineIn 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. |
| Low dose | Experimental | Drug: 0.01% atropineIn 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. |
| Placebo | Placebo comparator | Drug: 0.9% Sodium-chlorideIn 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% atropine and 0.01% atropineAlso: Loading dose0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months | Drug | Loading dose |
| 0.01% atropineAlso: Low-dose0.01% atropine for 24 months | Drug | Low dose |
| 0.9% Sodium-chlorideAlso: PlaceboPlacebo for 24 months | Drug | Placebo |
Primary outcome
Axial Length at 36 Months
Time frame: 36 months
Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700
Spherical Equivalent at 36 Months
Time frame: 36 months
Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction
2 secondary outcomes
Adverse Events
Time frame: 36 months
Change in Choroidal Thickness From Baseline to 36 Months
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39522589Hansen NC, Behrens CM, Hvid-Hansen A, Hamann S, Kessel L. Peripapillary hyperreflective ovoid mass-like structure (PHOMS): prevalence, risk factors, and development over time in Danish myopic children. J AAPOS. 2024 Dec;28(6):104034. doi: 10.1016/j.jaapos.2024.104034. Epub 2024 Nov 8.
- Derived from this study: PubMed 39422837Hansen 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.
- Derived from this study: PubMed 37904082Hansen 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.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.1% atropine and 0.01% atropine, 0.01% atropine and 0.9% Sodium-chloride in people with Myopia, run by Line Kessel at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial Length at 36 Months (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911271, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.