Health TrialsbyHealthPanel

MAD Trial: Myopia Atropine Dose

ConditionProgressive Myopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atropine Ophthalmic 0.05%

    Drug

    Atropine 0.05% sulphate ophthalmic solution

  • Atropine Ophthalmic 0.5%

    Drug

    Atropine 0.5% sulphate ophthalmic solution

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: Low dose atropineActive comparator 1 intervention
Group B: High dose atropineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

1

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

Time frame
5 years
2

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

Time frame
3 years
3

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

Time frame
5 years
4

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Source ClinicalTrials.gov
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