Atropine in the Treatment of Myopia Study in Malaysia
Recruiting
Phase 3
Interventional Study
Myopia Progression
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 10
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 144 (estimated)
- Sponsor
- IDB VisionCare SDN BHD · Industry
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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.
Trial Locations
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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 a…
Contacts