Atropine in the Treatment of Myopia Study in Malaysia

NCT07329777 | Recruiting Phase 3 DMC

• 1 other identifier: CT01-ATOM-MY-2022
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myopia Progression

Outcome Measures

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.

  12 months

Secondary Outcomes (2)

• 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

  24 months

• To demonstrate the superiority of eye drop formulation (Atropine Sulpahte 0.025% w/v Eye Drops) against placebo by axial length

  12 months

Study Arms (2)

Atropine Sulphate 0.025% w/v Eye Drops

ACTIVE COMPARATOR

Participants will be instructed to administer one drop of Atropine Sulphate 0.025% w/v Eye Drops into each eye once daily at bedtime for a duration of 24 months.

Drug: Low dose atropine sulfate eye drops

Placebo

PLACEBO COMPARATOR

Participants will be instructed to administer one drop of Placebo Eye Drops into each eye once daily at bedtime for a duration of 12 months and Atropine Sulphate 0.025% w/v Eye Drops from 13-24 months onwards.

Drug: Placebo

Interventions

Low dose atropine sulfate eye drops DRUG

Atropine Sulphate 0.025% w/v Eye Drops

Atropine Sulphate 0.025% w/v Eye Drops

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Children must be in good general health with no history of cardiac or respiratory diseases as per investigator's discretion and does not affect the study treatment or subsequent follow-ups.
• No asthma-requiring medications in the past one year.
• No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
• Willing and able to comply with scheduled visits and other study procedures.
• Written Informed Consent from parent and assent from child has been obtained.

You may not qualify if:

• 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.
• Previous or current use of atropine or pirenzepine.
• Children with any other conditions precluding adherence to the protocol including unwillingness to refrain from the use of other myopia control drug, contact lens or spectacles (except normal) spectacles including tinted/anti-glare glasses) etc. for the duration of the study.
• Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement.
• Children participated in any clinical study within 30 days prior to randomization.

Sponsors & Collaborators

• Singapore National Eye Centre: collaborator
• IDB VisionCare SDN BHD: lead

Study Sites (2)

Hospital Pakar Kanak-Kanak UKM

Kuala Lumpur, Cheras, 56000, Malaysia

RECRUITING

Universiti Malaya Medical Centre

Kuala Lumpur, Petaling Jaya, 50603, Malaysia

RECRUITING

Central Study Contacts

Nor Syakirah Zainal

CONTACT

+60143213786; atommy@idbvisioncare.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: January 9, 2026
• Study Start: September 17, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

MY (2)