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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low dose atropine sulfate eye drops
DrugAtropine Sulphate 0.025% w/v Eye Drops
Placebo
DrugPlacebo
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Atropine Sulphate 0.025% w/v Eye DropsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent
Spherical equivalent refraction determined by cycloplegic autorefraction from baseline to 12 months at each visit.
Time frame
12 monthsSecondary outcomes
1
To demonstrate continued efficacy of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) of 24 months with the comparison of 12 months by spherical equivalent
Determination of rate of progression in year 2 vs year 1 via Spherical equivalent refraction as determined by cycloplegic autorefraction of 24 months with the comparison of 12 months.
Time frame
24 months2
To demonstrate the superiority of eye drop formulation (Atropine Sulpahte 0.025% w/v Eye Drops) against placebo by axial length
Axial length as determined by non-contact partial coherence interferometry from baseline to 12 months at each visit.
Time frame
12 monthsSponsors and contacts
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IDB VisionCare SDN BHD
Lead sponsor
Singapore National Eye Centre
Collaborator
Source ClinicalTrials.gov