Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Recruiting
N/A
Interventional Study
Myopia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 5 – 8
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 110 (estimated)
- Sponsor
- S-Alpha Therapeutics, Inc. · Industry
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About This Trial
The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Children aged 5 to less than 9
2. Meet the following refractive criteria by cycloplegic refraction
1. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
2. Astigmatism of 1.50 D or less in each eye
3. Anisometropia of 2.00 D or less
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Contacts