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 |
Trial Parameters
Eligibility Fast-Check
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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, cyclo