Skip to content
Clinical Trials – home

Atropine Sulfate Monohydrate: A Promising Treatment for Myopia in Children

1 / 4
trials open to patients / all trials
7+
Countries

In short

Atropine Sulfate Monohydrate is a medication being studied in various clinical trials for its potential benefits in eye care and emergency medicine. These trials are investigating its use in treating myopia (nearsightedness) in children and as part of emergency medical procedures. The studies aim to determine the safety, effectiveness, and optimal dosing of this drug for different medical conditions.

What is Atropine Sulfate Monohydrate?

Atropine Sulfate Monohydrate is a medication that belongs to a class of drugs called anticholinergics. It is derived from plants of the nightshade family and has been used in medicine for various purposes. In ophthalmology, atropine is primarily known for its ability to dilate the pupil and relax the eye's focusing mechanism.

Atropine for Myopia Treatment

In recent years, atropine has gained significant attention as a potential treatment for myopia (nearsightedness) in children. Myopia is a condition where distant objects appear blurry while close objects remain clear. It typically develops during childhood and can progress rapidly, leading to high myopia in some cases.

Atropine eye drops, in very low concentrations, have shown promise in slowing down the progression of myopia in children. This treatment approach is particularly important because it addresses a growing global health concern, as the prevalence of myopia is increasing worldwide.

How Atropine Works for Myopia

The exact mechanism by which atropine slows myopia progression is not fully understood. However, researchers believe it may work in several ways:

  • Inhibiting eye elongation: Atropine may help prevent the eye from growing too long, which is a key factor in myopia development.
  • Affecting the focusing mechanism: By relaxing the eye's ciliary muscle, atropine may reduce the stress on the eye during close-up work.
  • Biochemical effects: Atropine may influence biochemical pathways in the eye that are involved in myopia progression.

Effectiveness in Slowing Myopia Progression

Clinical trials have shown that low-dose atropine eye drops can be effective in slowing the progression of myopia in children. One study is investigating the efficacy of SYD-101, an atropine-based ophthalmic solution, in different concentrations (0.01% and 0.03%) compared to a placebo.

Another study is examining the effects of 0.02% and 0.04% atropine eye drops versus a placebo. The primary objective is to determine the difference in axial eye length (AXL) over a 12-month application period. Axial eye length is a key measure of myopia progression, as increased eye length is associated with worsening myopia.

Dosage and Administration

Atropine for myopia control is typically used in very low concentrations, ranging from 0.01% to 0.05%. These concentrations are much lower than those used for other ophthalmic purposes. The medication is usually administered as eye drops, with one drop applied to each eye daily, often at bedtime.

It's important to note that the optimal concentration and treatment duration are still being researched. Some studies are investigating treatment periods of up to 24 months, followed by a period of observation to assess any rebound effects after discontinuation.

Potential Side Effects

While low-dose atropine appears to be well-tolerated, it can cause some side effects. These may include:

  • Pupil dilation (making eyes more sensitive to light)
  • Blurred near vision
  • Difficulty focusing on close objects
  • Mild eye irritation

Researchers are closely monitoring both systemic (body-wide) and ophthalmological (eye-related) side effects in ongoing clinical trials. It's crucial to use atropine under the supervision of an eye care professional, as they can monitor for any adverse effects and adjust treatment as needed.

Ongoing Research

Several clinical trials are currently underway to further investigate the use of atropine for myopia control in children. These studies aim to:

  • Determine the optimal concentration of atropine for maximum efficacy and minimal side effects.
  • Assess the long-term effects of atropine treatment, including any rebound effects after discontinuation.
  • Evaluate the impact of atropine on various aspects of eye health and function, including visual acuity, contrast sensitivity, and color perception.
  • Investigate the influence of genetic predisposition and lifestyle factors on treatment outcomes.
  • Assess the quality of life and comfort associated with atropine therapy in children.

Conclusion

Atropine Sulfate Monohydrate, in the form of low-concentration eye drops, shows promising results in slowing the progression of myopia in children. While more research is needed to fully understand its long-term effects and optimal use, it represents an important development in the management of childhood myopia. Parents of children with myopia should consult with an eye care professional to discuss whether atropine treatment might be appropriate for their child.

Questions people often ask

Conditions where Atropine Sulfate Monohydrate is being studied

Each condition opens its own overview and trial list

Trials with Atropine Sulfate Monohydrate

Recruiting trials first

See all 4 →
Quick filters
  • Participants:Adults · Healthy volunteers
  • Participants:All ages
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).