A Phase 3 interventional study of Atropine Ophthalmic 0.05% and Atropine Ophthalmic 0.5% in Progressive Myopia, sponsored by Erasmus Medical Center. Active, not recruiting at 20 sites in Netherlands. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Erasmus Medical Center · Phase 3, Interventional, and Treatment
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.
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.
70 studies on the registry are indexed under Myopia, Degenerative; 19 are open to participants now.
This study's planned enrollment of 550 is above the median of 121 across 56 interventional studies indexed under Myopia, Degenerative.
Browse Myopia, Degenerative studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Drug: Atropine Ophthalmic 0.05%
Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Drug: Atropine Ophthalmic 0.5%
Atropine 0.05% sulphate ophthalmic solution
Atropine 0.5% sulphate ophthalmic solution
Progression of axial length in mm from baseline to t = 36 months.
Time frame: 3 years
Progression of axial length in mm from baseline to t = 60 months.
Time frame: 5 years
Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.
Time frame: 3 years
Progression of spherical equivalent of refraction in dioptres from baseline to t = 60
Time frame: 5 years
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
Proportion of subjects who progressed to high myopia (AL 26+ mm)
Time frame: 3 years
Change in visual function (BCVA, contrast sensitivity, and glare)
Time frame: 3 years
Frequency and type of treatment-related (serious) adverse events as assessed by CTCAE v5.0 (=safety)
Time frame: 3 years
Proportion of non-adherence
Time frame: 3 years
Difference in health related quality of life
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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