Yes, 0.01% Atropine Eye Drops Exist and Are Widely Used
Yes, 0.01% atropine eye drops exist and are extensively studied and used clinically, particularly for myopia control in children. While the FDA-approved formulation is 1% atropine sulfate ophthalmic solution 1, the 0.01% concentration is prepared through compounding and has been the subject of numerous randomized controlled trials worldwide.
Clinical Evidence for 0.01% Atropine
The 2023 American Academy of Ophthalmology Refractive Errors Preferred Practice Pattern explicitly discusses 0.01% atropine as an established treatment option 2. The guidelines state that:
- 0.01% atropine has been found to have efficacy in controlling myopia progression compared with 0.1% and 0.5% concentrations, with minimal side effects 2
- Multiple randomized controlled trials from Taiwan, Singapore, Hong Kong (LAMP study), and the United States have evaluated this specific concentration 2
- The LAMP study specifically compared 0.05%, 0.025%, and 0.01% concentrations over 2 years, confirming that all three low-dose formulations exist and have been rigorously studied 2
Availability and Preparation
Since 0.01% atropine is not commercially available as an FDA-approved product, it must be:
- Compounded by specialty pharmacies from the 1% FDA-approved formulation
- Diluted to the appropriate concentration for clinical use
- Prepared following proper pharmaceutical compounding standards
The FDA label for atropine sulfate ophthalmic solution only describes the 1% formulation 1, but this does not preclude the existence or clinical use of compounded lower concentrations.
Recent Clinical Trial Evidence
Multiple high-quality studies confirm the existence and use of 0.01% atropine:
- A 2024 US-based randomized clinical trial (JAMA Ophthalmology) directly compared 0.01% atropine versus placebo in 187 children 3
- A 2024 Danish trial evaluated both 0.1% loading dose followed by 0.01% maintenance therapy 4
- A 2024 Chinese trial (AMIXT) studied 0.01% atropine in 300 children with myopia and intermittent exotropia 5
- A 2025 study compared twice-daily versus once-nightly 0.01% atropine administration 6
Efficacy Profile
The evidence shows that 0.01% atropine:
- Slows myopia progression by approximately 37% annually overall 7
- Demonstrates ethnic variation in efficacy (66% reduction in South Asian populations, 35% in East Asian, 28% in White populations) 7
- Has minimal side effects compared to higher concentrations, including less photophobia, less accommodation loss, and less pupillary dilation 2
- Shows less myopic rebound upon discontinuation compared to 0.5% atropine 2
Important Clinical Caveat
The 2023 US-based JAMA trial found that 0.01% atropine was NOT effective in slowing myopia progression in American children (adjusted difference -0.02 D; 95% CI -0.19 to +0.15 D; P=0.83) 3. This contrasts with positive findings in Asian populations, suggesting potential ethnic or environmental differences in treatment response. However, this does not negate the existence of the formulation—it simply questions its universal efficacy across all populations.
Bottom Line
0.01% atropine eye drops definitively exist as a compounded formulation and have been extensively studied in clinical trials worldwide. They are recognized in major ophthalmology guidelines as a treatment option for myopia control, though they require compounding from the FDA-approved 1% formulation and their efficacy may vary by population 2, 7, 3.