Atropine in the Treatment of Myopia Study in Malaysia
ConditionMyopia Progression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-10
SponsorIDB VisionCare SDN BHD
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Low dose atropine sulfate eye drops
- Placebo
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
IDB VisionCare SDN BHD
Lead sponsor
Singapore National Eye Centre
Collaborator
Source ClinicalTrials.gov