RecruitingPhase 3

Atropine in the Treatment of Myopia Study in Malaysia

Malaysia144 participantsStarted 2025-09-17

Plain-language summary

This clinical trial is designed to assess the efficacy and safety of Atropine Sulphate 0.025% w/v Eye Drops compared to placebo in a randomized, double-blind, placebo-controlled study for the management of myopia progression in children.

Who can participate

Age range5 Years – 10 Years

SexALL

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Inclusion criteria

✓. Male or female children between 5 to 10 years of age.
✓. Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
✓. Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
✓. Children with astigmatism of less than -1.50 D
✓. Children having distance vision correctable to logMAR 0.2 or better in both eyes.
✓. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
✓. Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
✓. Children with normal ocular health other than myopia.

Exclusion criteria

✕. History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
✕. Children with prior and/or concomitant use of other myopia control drugs, contact lens or spectacles (except normal spectacles including tinted/anti-glare glasses) etc.
✕. Children with congenital myopia.
✕. Children using Ortho K and Myopia Lens.
✕. Children with ocular or systemic diseases which may affect vision or refractive error.
✕. Children with any ocular condition wherein topical atropine is contraindicated.
✕. Children with defective binocular function or stereopsis.
✕. Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia.

What they're measuring

To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent

Timeframe: 12 months

Trial details

NCT IDNCT07329777

SponsorIDB VisionCare SDN BHD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Nor Syakirah Zainal

+60143213786 atommy@idbvisioncare.com

View on ClinicalTrials.gov More Myopia Progression trials