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Progressive MyopiaPhase 3MADNCT05667454

MAD Trial: Myopia Atropine Dose

A Phase 3 study testing Atropine Ophthalmic 0.05% and Atropine Ophthalmic 0.5% in people with Progressive Myopia, run by Erasmus Medical Center at 20 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Progressive Myopia
What is being tested?
Atropine Ophthalmic 0.05% and Atropine Ophthalmic 0.5%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
20 sitesNetherlands
Study dates
19 Dec 2022to 24 Apr 2029
Phase
Phase 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 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6 to ≤ 11 years with bilateral myopia
  • Onset of myopia ≥ 4 years of age
  • History of progression
  • SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
  • Intraocular pressure < 21 mm Hg in each eye
  • Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye

Who cannot join

  • Allergy to atropine or other excipients of the eye drops
  • History of amblyopia or strabismus
  • History of retinal dystrophy or systemic disorder
  • Abnormal ocular biometry aside from axial length
  • History of glaucoma
  • Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).
Show all 10Show fewer
  • Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.
  • The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks)
  • Prior myopia treatments.
  • Employees of the study center and their family members.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Netherlands20 sites

  • Flevoziekenhuis

    Almere Stad

  • OLVG, locatie Oost

    Amsterdam

  • Ophthalmologistenpraktijk Delfland

    Delft

  • Reinier de Graaf Gasthuis

    Delft

  • Deventer Ziekenhuis

    Deventer

  • Albert Schweitzer ziekenhuis

    Dordrecht

  • Bergman Clinics - Ede

    Ede

  • Admiraal de Ruyter Ziekenhuis

    Goes

  • Frisius MC

    Heerenveen

  • Oogcentrum Noordholland

    Heerhugowaard

  • Leiden University Medical Center

    Leiden

  • Bergman Clinics - Lelystad

    Lelystad

  • Maastricht UMC+

    Maastricht

  • St. Antonius

    Nieuwegein

  • Radboudumc

    Nijmegen

  • Erasmus Medical Center

    Rotterdam

  • Haga Ziekenhuis

    The Hague

  • Oogkliniek Den Haag

    The Hague

  • Ziekenhuis Rivierenland Tiel

    Tiel

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg

Other trials in Netherlands

About this study

Official title: Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.

Read the detailed description

With the current worldwide myopia boom the frequency of high myopia will also increase, and potentially blinding complications such as myopic macular degeneration, retinal detachment, and glaucoma will occur more often. In the Netherlands high myopia will become the most important cause of low vision and blindness by 2050. As treatment options are limited once the eye is fully grown, prevention of a long axial length at childhood is the only way to counteract this prospect. Pharmacological interventions have shown a high efficacy in stopping eye growth, in particular eye drops with high dose Atropine (0.5%, 1%). Nevertheless, the high frequency of side effects (photophobia, reading problems) of these Atropine concentrations has favoured the use of low dose Atropine. Atropine 0.01% is the most commonly used and lowest dosage; it has shown stability of refractive error, but not of axial length. Recent studies have shown that Atropine 0.05% has low risk of side effects, but a higher efficacy than 0.01%. Many ongoing trials are now comparing various low dose Atropine to placebo, but none are comparing the highest low dose to the lowest high dose Atropine.

Being tested
Atropine Ophthalmic 0.05%, Atropine Ophthalmic 0.5%
Keywords
Myopia, Atropine, Axial length, Child
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 Ophthalmic 0.05%Drug

    Atropine 0.05% sulphate ophthalmic solution

  • Atropine Ophthalmic 0.5%Drug

    Atropine 0.5% sulphate ophthalmic solution

Study groups in NCT05667454
Study groupRoleWhat they receive
Low dose atropineActive comparatorAtropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Receives: Drug: Atropine Ophthalmic 0.05%
High dose atropineActive comparatorAtropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Receives: Drug: Atropine Ophthalmic 0.5%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression of axial length in mm from baseline to t = 36 months.

    Measured: 3 years

Secondary outcomes (9)

  1. Progression of axial length in mm from baseline to t = 60 months.

    Measured: 5 years

  2. Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.

    Measured: 3 years

  3. Progression of spherical equivalent of refraction in dioptres from baseline to t = 60

    Measured: 5 years

  4. Proportion of subjects who show ≤ 0.20 mm (good response); 0.2 - 0.3 mm (acceptable response), and > 3 mm (nonresponse)

    Measured: 3 years

  5. Proportion of subjects who progressed to high myopia (AL 26+ mm)

    Measured: 3 years

  6. Change in visual function (BCVA, contrast sensitivity, and glare)

    Measured: 3 years

  7. Frequency and type of treatment-related (serious) adverse events as assessed by CTCAE v5.0 (=safety)

    Measured: 3 years

  8. Proportion of non-adherence

    Measured: 3 years

  9. Difference in health related quality of life

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start19 Dec 2022
  3. Primary completion24 Apr 2029 (estimated)
  4. Study completion24 Apr 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05667454
Sponsor's protocol ID
NL78526.078.21
Other IDs
MEC-2021-0814, 2021-004015-11
Acronym
MAD
Status last verified
Sep 2026
First submitted
21 Nov 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atropine Ophthalmic 0.05% and Atropine Ophthalmic 0.5% in people with Progressive Myopia, run by Erasmus Medical Center at 20 sites in Netherlands.

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 6 inclusion and 10 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Netherlands. 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 phase mean?

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?

Progression of axial length in mm from baseline to t = 36 months. (time frame: 3 years). 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 NCT05667454.

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 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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