Atropine Drops for Nearsightedness

(DONUT Trial)

This trial tests whether nightly atropine eye drops can slow nearsightedness in children. Researchers aim to determine if these drops can delay the onset of nearsightedness and slow eye growth over two years compared to placebo drops. Suitable participants have experienced some vision changes but are not yet significantly nearsighted and have no other major eye conditions or surgeries. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment for nearsightedness in children.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

A previous study found atropine 0.05% eye drops effective for children with rapidly worsening nearsightedness, without major side effects. Research has shown that this dosage best controls nearsightedness over time. Some mild side effects, such as difficulty seeing up close and light sensitivity, were reported, but these did not prevent children from continuing treatment. Other studies confirm that atropine is safe and well-tolerated at low doses. Overall, the eye drops have a strong safety record, with only minor and manageable side effects.¹²³⁴⁵

Unlike most treatments for nearsightedness, which often involve corrective lenses or refractive surgery, atropine drops offer a non-invasive option. Researchers are particularly excited about the low-dose 0.05% atropine solution because it specifically targets the progression of nearsightedness by slowing down the elongation of the eyeball. This approach not only aims to manage symptoms but also addresses the underlying condition, potentially reducing the need for stronger prescriptions over time. The convenience of nightly eye drops makes it an attractive alternative for those seeking to manage nearsightedness effectively and comfortably.

This trial will compare 0.05% atropine eye drops with a placebo to evaluate their effectiveness in slowing the progression of nearsightedness in children. Studies have shown that atropine eye drops can effectively slow this progression, with 0.05% atropine outperforming lower concentrations like 0.01% in controlling nearsightedness. Research indicates that using 0.05% atropine over time yields good results in slowing the worsening of nearsightedness. Additionally, this concentration has proven safe for children. Overall, these findings suggest that 0.05% atropine could be a promising option for managing nearsightedness in children.²⁴⁶⁷⁸