Myopia, ProgressivePhase 2/3AIMNCT03865160
Low-dose Atropine for Myopia Control in Children
A Phase 2/3 study testing Atropine eye drops, 0.01% and Atropine eye drops, 0.02% in people with Myopia, Progressive, run by University Eye Hospital, Freiburg at 19 sites in Germany.
Trial summary
Myopia (nearsightedness) is the most common eye disorder. Only second to age, it is the main risk factor for major degenerative eye diseases such as glaucoma, macular degeneration or retinal detachment. Their risk increases with the degree of myopia. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Atropine eye drops, 0.01% and Atropine eye drops, 0.02%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 19 sitesGermany
- Study dates
- 19 Oct 2021to Nov 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
- Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
Who cannot join
- Asian or African origin
- Abnormal binocularity
- Strabismus
- Astigmatism >1.5 D
- Anisometropia >1.5 D
- History of amblyopia
Show all 20Show fewer
- Corrected visual acuity in any eye <0.63
- Any acquired or developmental organic eye disease
- Premature birth
- Any known systemic metabolic disease or chromosomal anomaly
- Previous use of any kind of contact lenses
- Previous use of atropine eye drops
- Epilepsy
- Known hypersensitivity to the active substances or any of the excipients
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
- Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
- 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
- Parents or children with poor understanding of the German language
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Augen-Zentrum-Nordwest, Augenpraxis Ahaus
Ahaus, 48683
Universitäts-Augenklinik Bonn
Bonn, 53127
Uniklinik Köln, Zentrum für Augenheilkunde
Cologne, 50937
Universitätsklinikum Erlangen, Augenklinik
Erlangen, 91054
Universitätsklinikum Essen, Klinik für Augenheilkunde
Essen, 45147
Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, 79106
Universitätsmedizin Göttingen, Augenklinik
Göttingen, 37075
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde
Hamburg, 20246
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625
Universitätsklinikum Heidelberg, Augenklinik
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Universitätsklinikum Leipzig, Klinik und Poliklinik für Augenheilkunde
Leipzig, 04103
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, 39120
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, 55131
Ludwig-Maximilians-Universität München, Augenklinik und Poliklinik
München, 80336
Klinik für Augenheilkunde des UKM, Gebäude D15
Münster, 48149
Pius-Hospital Oldenburg, Medizinischer Campus Universität Oldenburg, Universitätsklinik für Augenheilkunde
Oldenburg, 26121
AugenCentrum Rosenheim
Rosenheim, 83022
Universitätsklinikum Ulm, Klinik für Augenheilkunde
Ulm, 89075
About this study
Official title: Low-dose Atropine for Myopia Control in Children, a Prospective, Double-blind, Placebo-controlled, Multicentric, Randomized Clinical Trial
Myopia (nearsightedness) is the most common eye disorder. Only second to age, it is the main risk factor for major degenerative eye diseases such as glaucoma, macular degeneration or retinal detachment. Their risk increases with the degree of myopia. Hence, prevention of myopia and slowing its progression is of high relevance. Almost all clinical studies, including two large randomised clinical trials (RCT) were performed in Asia with Asian study participants. The results indicate that atropine eye drops can attenuate myopic progression in children, even in low concentrations thus minimizing unwanted side effects. However, the cumulative evidence is yet not strong enough to recommend their unrestricted use, especially in a Non-Asian population. We therefore intend to set up an adequately powered RCT comparing atropine 0.02% eye drops with placebo to validate previous findings and to test whether this therapeutic concept holds its promise in a European population.
Read the detailed description
Myopia (nearsightedness) is the most common developmental eye disorder in the first decades of life. It is the biggest risk factor for sight threatening degenerative eye diseases later in life, second only to age. Its prevalence is increasing worldwide in pandemic dimensions affecting now > 80% in Asian and > 40% in Caucasian populations. Myopia is one of the five eye diseases identified as immediate priorities by the WHO's global initiative for the elimination of avoidable blindness. It usually develops during primary school and its onset and progression are related to environmental factors such as near work and lack of day light exposure, to a lesser degree to genetic factors. Therefore, retardation of myopia progression is a major therapeutic goal. Clinical trials from Asia have shown that 0.01% atropine eye drops can attenuate progression of myopia while inducing only little side effects such as light sensitivity and reduced accommodation. Subsequent data also from Asia have suggested that a concentration of 0.05% atropine is slightly more effective with a still acceptable level of adverse effects. However, it is unclear whether this therapy is equally and sufficiently efficacious in a Caucasian population. It is also unclear which concentration of atropine represents the best compromise between efficacy and safety. Our own uncontrolled pilot data suggest that 0.01% delays progression by about 50% with negligible side effects, but that 0.05% induces a pupil dilation of > 3 mm, which is considered unacceptable. Due to the increasing prevalence also in Europe and an increasing demand from parents for means to retard myopia progression, the trial is the first European large scale randomized clinical trial investigating the safety and efficacy of 0.01% and 0.02% atropine eye drops in comparison to placebo drops. Such a trial is mandatory to substantiate the increasing off-label prescriptions of low-dose atropine in children and to develop clinical guidelines.
- Conditions
- Myopia, Progressive
- Being tested
- Atropine eye drops, 0.01%, Atropine eye drops, 0.02%, Placebo (NaCl 0.9%) eye drops
- Keywords
- Myopia, Children, Atropine, Low-dose, 0.01, 0.02
- Medical subject headings
- Myopia, Degenerative, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine eye drops, 0.01%Drug
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Atropine eye drops, 0.02%Drug
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Placebo (NaCl 0.9%) eye dropsDrug
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Arm A, Interventional group | Experimental | Treatment period 1: Atropine eye drops, 0.02%, 1 drop/eye, daily for 12 months Treatment period 2: Atropine eye drops, 0.02%, 1 drop/eye, daily for 12 months Treatment period 3: Placebo (NaCl 0.9%) eye drops, 1 drop/eye, daily for 12 months Receives: Drug: Atropine eye drops, 0.02%; Drug: Placebo (NaCl 0.9%) eye drops |
| Arm B, Control group | Experimental | Treatment period 1: Placebo (NaCl 0.9%) eye drops, 1 drop/eye, daily for 12 months Treatment period 2: Atropine eye drops, 0.01%, 1 drop/eye, daily for 12 months Treatment period 3: Atropine eye drops, 0.01%, 1 drop/eye, daily for 12 months Receives: Drug: Atropine eye drops, 0.01%; Drug: Placebo (NaCl 0.9%) eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control
Change in cycloplegic refraction [dioptre (D)/year] after one year will be performed using an analysis of covariance (ANCOVA) model with the annual change in refraction as the dependent variable. The mean value of both eyes is analysed.
Measured: Baseline - 12 months
Secondary outcomes (2)
Assessment of axial eye length growth under low-dose atropine 0.02% in comparison to placebo
Change in axial length [mm/year]. The mean value of both eyes is analysed. Analyses will be performed in a regression model.
Measured: Baseline - 12 months
Assessment of the categorized rate of change in refraction of low-dose atropine 0.02% compared to placebo
The primary endpoint change in cycloplegic refraction after one year will be categorized (patients progressing < 0.25D (dioptre), 0.25D - 0.75D and > 0.75D after one year of treatment) and will be analysed descriptively, giving absolute and relative frequencies of these categories as a supportive analysis.
Measured: Baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start19 Oct 2021
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Year one: arm A atropine 0.02% / arm B placebo Year two: arm A atropine 0.02% / arm B atropine 0.01% Year three: arm A placebo/ arm B atropine 0.01%
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Eye Hospital, Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolf Lagrèze, Prof., Principal investigator, Eye Center, Medical Center, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865160
- Sponsor's protocol ID
- P001307
- Other IDs
- DRKS00023337, 2020-001575-33
- Acronym
- AIM
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2019
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farassat N, Bohringer D, Kuchlin S, Molnar FE, Schwietering A, Seger D, Hug MJ, Knobel AB, Schneider-Fuchs S, Ihorst G, Wabbels B, Beisse C, Ziemssen F, Schuettauf F, Hedergott A, Ring-Mangold T, Schuart C, Wolf A, Schmickler S, Biermann J, Eberwein P, Hufendiek K, Eckstein A, Gusek-Schneider G, Schittkowski M, Lischka T, Lagreze WA. Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms. BMJ Open. 2023 Apr 20;13(4):e068822. doi: 10.1136/bmjopen-2022-068822.
PubMed 37080623
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Atropine for Myopia Control in Children, a Prospective, Double-blind, Placebo-controlled, Multicentric, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03865160
- Acronym / sponsor ID
- AIM / P001307
- Conditions
- Myopia, Progressive
- Keywords
- Myopia, Children, Atropine, Low-dose, 0.01, 0.02
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University Eye Hospital, FreiburgUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
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 the most common eye disorder. Only second to age, it is the main risk factor for major degenerative eye diseases such as glaucoma, macular degeneration or retinal detachment. Their risk increases with the degree of myopia. Hence, prevention of myopia and slowing its progression is of high relevance. Almost all clinical studies, including two large randomised clinical trials (RCT) were performed in Asia with Asian study participants. The results indicate that atropine eye drops can attenuate myopic progression in children, even in low concentrations thus minimizing unwanted side effects. However, the cumulative evidence is yet not strong enough to recommend their unrestricted use, especially in a Non-Asian population. We therefore intend to set up an adequately powered RCT comparing atropine 0.02% eye drops with placebo to validate previous findings and to test whether this therapeutic concept holds its promise in a European population.
Detailed description
Myopia (nearsightedness) is the most common developmental eye disorder in the first decades of life. It is the biggest risk factor for sight threatening degenerative eye diseases later in life, second only to age. Its prevalence is increasing worldwide in pandemic dimensions affecting now > 80% in Asian and > 40% in Caucasian populations. Myopia is one of the five eye diseases identified as immediate priorities by the WHO's global initiative for the elimination of avoidable blindness. It usually develops during primary school and its onset and progression are related to environmental factors such as near work and lack of day light exposure, to a lesser degree to genetic factors. Therefore, retardation of myopia progression is a major therapeutic goal. Clinical trials from Asia have shown that 0.01% atropine eye drops can attenuate progression of myopia while inducing only little side effects such as light sensitivity and reduced accommodation. Subsequent data also from Asia have suggested that a concentration of 0.05% atropine is slightly more effective with a still acceptable level of adverse effects. However, it is unclear whether this therapy is equally and sufficiently efficacious in a Caucasian population. It is also unclear which concentration of atropine represents the best compromise between efficacy and safety. Our own uncontrolled pilot data suggest that 0.01% delays progression by about 50% with negligible side effects, but that 0.05% induces a pupil dilation of > 3 mm, which is considered unacceptable. Due to the increasing prevalence also in Europe and an increasing demand from parents for means to retard myopia progression, the trial is the first European large scale randomized clinical trial investigating the safety and efficacy of 0.01% and 0.02% atropine eye drops in comparison to placebo drops. Such a trial is mandatory to substantiate the increasing off-label prescriptions of low-dose atropine in children and to develop clinical guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Year one: arm A atropine 0.02% / arm B placebo Year two: arm A atropine 0.02% / arm B atropine 0.01% Year three: arm A placebo/ arm B atropine 0.01%
| Arm | Type | Receives |
|---|---|---|
| Arm A, Interventional group | Experimental | Drug: Atropine eye drops, 0.02%, Drug: Placebo (NaCl 0.9%) eye dropsTreatment period 1: Atropine eye drops, 0.02%, 1 drop/eye, daily for 12 months Treatment period 2: Atropine eye drops, 0.02%, 1 drop/eye, daily for 12 months Treatment period 3: Placebo (NaCl 0.9%) eye drops, 1 drop/eye, daily for 12 months |
| Arm B, Control group | Experimental | Drug: Atropine eye drops, 0.01%, Drug: Placebo (NaCl 0.9%) eye dropsTreatment period 1: Placebo (NaCl 0.9%) eye drops, 1 drop/eye, daily for 12 months Treatment period 2: Atropine eye drops, 0.01%, 1 drop/eye, daily for 12 months Treatment period 3: Atropine eye drops, 0.01%, 1 drop/eye, daily for 12 months |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
- Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
Key exclusion criteria (20 listed)
- Asian or African origin
- Abnormal binocularity
- Strabismus
- Astigmatism >1.5 D
- Anisometropia >1.5 D
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 |
|---|---|---|
| Atropine eye drops, 0.01%One drop of the above mentioned drug will be installed into each eye daily at bedtime. | Drug | Arm B, Control group |
| Atropine eye drops, 0.02%One drop of the above mentioned drug will be installed into each eye daily at bedtime. | Drug | Arm A, Interventional group |
| Placebo (NaCl 0.9%) eye dropsOne drop of the above mentioned drug will be installed into each eye daily at bedtime. | Drug | Arm A, Interventional group, Arm B, Control group |
Primary outcome
Demonstration of superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control
Time frame: Baseline - 12 months
Change in cycloplegic refraction [dioptre (D)/year] after one year will be performed using an analysis of covariance (ANCOVA) model with the annual change in refraction as the dependent variable. The mean value of both eyes is analysed.
2 secondary outcomes
Assessment of axial eye length growth under low-dose atropine 0.02% in comparison to placebo
Time frame: Baseline - 12 months
Assessment of the categorized rate of change in refraction of low-dose atropine 0.02% compared to placebo
Time frame: Baseline - 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Results publication: PubMed 37080623Farassat N, Bohringer D, Kuchlin S, Molnar FE, Schwietering A, Seger D, Hug MJ, Knobel AB, Schneider-Fuchs S, Ihorst G, Wabbels B, Beisse C, Ziemssen F, Schuettauf F, Hedergott A, Ring-Mangold T, Schuart C, Wolf A, Schmickler S, Biermann J, Eberwein P, Hufendiek K, Eckstein A, Gusek-Schneider G, Schittkowski M, Lischka T, Lagreze WA. Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms. BMJ Open. 2023 Apr 20;13(4):e068822. doi: 10.1136/bmjopen-2022-068822.
- Homepage of AIM (German language)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Wolf Lagrèze, Prof. principal investigator
Eye Center, Medical Center, University Hospital Freiburg
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atropine eye drops, 0.01% and Atropine eye drops, 0.02% in people with Myopia, Progressive, run by University Eye Hospital, Freiburg at 19 sites in Germany.
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 4 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Demonstration of superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control (time frame: Baseline - 12 months). 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 NCT03865160, which also lists 1 linked publication.
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 6 Mar 2025.