The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
Recruiting
Phase 3
Interventional Study
Myopia
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
- 6 – 12
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 606 (estimated)
- Sponsor
- Oupushifang Pharmaceutical Technology Co., Ltd. · Other
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About This Trial
The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents.
Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two l…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written informed consent voluntarily.
2. Patients with myopia aged 6 to 12 years, including cut-offs.
3. The equivalent spherical refraction…
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