NCT07329777 Atropine in the Treatment of Myopia Study in Malaysia
| NCT ID | NCT07329777 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | IDB VisionCare SDN BHD |
| Condition | Myopia Progression |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 144 participants in total. It began in 2025-09-17 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female children between 5 to 10 years of age. 2. Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye. 3. Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months. 4. Children with astigmatism of less than -1.50 D 5. Children having distance vision correctable to logMAR 0.2 or better in both eyes. 6. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D. 7. Children with normal intraocular pressure of not greater than 21 mmHg in either eye. 8. Children with normal ocular health other than myopia. 9. 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. 10. No asthma-requiring medications in the past one year. 11. No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride. 12. Willing and able to comply with scheduled visits and other study procedures. 13. Written Informed Consent from parent and assent from child has been obtained. Exclusion Criteria: 1. History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients. 2. 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. 3. Children with congenital myopia. 4. Children using Ortho K and Myopia Lens. 5. Children with ocular or systemic diseases which may affect vision or refractive error. 6. Children with any ocular condition wherein topical atropine is contraindicated. 7. Children with defective binocular function or stereopsis. 8. Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia. 9. Previous or current use of atropine or pirenzepine. 10. 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. 11. Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement. 12. Children participated in any clinical study within 30 days prior to randomization.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07329777 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 10 Years, studying Myopia Progression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07329777 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 144 participants.
Is NCT07329777 currently recruiting?
Yes, NCT07329777 is actively recruiting participants. Contact the research team at atommy@idbvisioncare.com for enrollment information.
Where is the NCT07329777 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia, Kuala Lumpur, Malaysia.
Who is sponsoring the NCT07329777 clinical trial?
NCT07329777 is sponsored by IDB VisionCare SDN BHD. The trial plans to enroll 144 participants.