Study of atropine eye drops (0.

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What is this study about?

This study focuses on treating myopia, commonly known as nearsightedness, in children and teenagers. The research examines the effectiveness of atropine eye drops in two different strengths (0.025% and 0.05%) compared to placebo in preventing the worsening of nearsightedness. Myopia is a vision condition where close objects appear clear, but objects farther away look blurry.

The study involves using eye drops containing atropine sulfate monohydrate or placebo. Participants will need to use the eye drops daily for 24 months. The drops are specifically designed for children and will be administered directly into the eyes. Each participant will receive two drops per day throughout the treatment period.

The purpose of this research is to determine if atropine eye drops can slow down the progression of myopia in young people between 3 and 18 years of age. During the study, doctors will regularly check how the participants’ vision changes by measuring their eye prescription and performing various vision tests. The study will track how well the different strengths of atropine work in preventing myopia from getting worse compared to the placebo treatment.

1 Initial treatment assignment

You will be randomly assigned to receive one of three treatments: atropine eye drops 0.025%, atropine eye drops 0.05%, or placebo eye drops.

The eye drops will be administered directly to your eyes. Neither you nor your doctor will know which treatment you are receiving.

2 Treatment period

The treatment will continue for 24 months (2 years).

You will need to use the eye drops as prescribed throughout the entire treatment period.

3 Regular check-ups

Your eyes will be examined at 3, 6, 12, 18, and 24 months.

During these visits, the following will be checked:

– Changes in your eye prescription

– Length of your eye

– Vision quality for both near and far sight

– Size of your pupil

– Your eye’s ability to focus

You will also complete a questionnaire about the eye drops and how they affect your daily life.

4 Safety monitoring

Your sensitivity to light will be monitored throughout the study.

Any unusual changes or side effects should be reported during check-ups.

If needed, you may receive special lenses to help with light sensitivity.

5 Early assessment

At 6 months, your eye condition will be evaluated to determine if the current treatment is adequate.

Changes to your treatment may be made based on how your eyes respond to the medication.

Who Can Join the Study?

Age requirement: Children and teenagers between 3 and 17 years old
Vision condition: Must have myopia (nearsightedness) of at least -0.75 diopters in both eyes
Eye pressure must be 21 mm Hg or lower in each eye (this is measured during an eye examination)
Parents or legal guardians must sign an informed consent form (except in UK where participants over 16 can provide their own consent)
For female participants who have started menstruation:
- Must have a negative pregnancy test
- If sexually active, must use effective birth control
For male participants who are sexually active:
- Must use effective birth control

Who Cannot Join the Study?

History of hypersensitivity (allergic reactions) to atropine or similar eye medications
Previous or current eye conditions other than myopia (such as glaucoma – increased pressure in the eye, or amblyopia – lazy eye)
Active eye infections or inflammation
Children under 3 years or adults over 18 years of age
Previous eye surgery or trauma
Use of contact lenses that cannot be discontinued during the study
Current participation in other clinical trials
Medical conditions that could affect eye examination results
Inability to follow study procedures or attend regular follow-up visits
Known cardiovascular conditions (heart problems) that could be affected by atropine
Severe neurological or psychiatric conditions that may interfere with the study
Pregnancy or planning pregnancy during the study period

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy

Other Sites

Site Name	City	Country
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Azienda Ospedaliera di Padova	Padua	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Pzvj Tcwdk Hxpiwhrx Uopcakcqiorq	Sabadell	Spain
Fpsnglbfg Pkte Lm Ipmtwslvvhgvu Bmsmsomst Dfw Hssqixak Ubcxhjatlvzko Lt Pau	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.11.2024
Poland	Recruiting	01.11.2024
Spain	Recruiting	01.11.2024

Trial locations

Investigated drugs:

Atropine Sulfate Monohydrate

Atropine is an eye drop medication used to help slow down the progression of myopia (nearsightedness) in children and adolescents. When applied to the eyes, it works by temporarily affecting the focusing ability of the eye and may help control how the eye grows during childhood. This medication has been used for many years in eye care and is being studied as a treatment to reduce the worsening of nearsightedness in young people.

Investigated diseases:

Myopia

Myopia – A common vision condition where close objects appear clear, but distant objects look blurry. This occurs when the eye grows too long from front to back, or the cornea has too much curvature, causing light rays to focus in front of the retina instead of directly on it. Myopia typically develops during childhood and can progress until early adulthood. The condition often runs in families and can worsen gradually or rapidly. People with myopia may experience headaches, eyestrain, squinting, and difficulty seeing objects at a distance such as school boards or road signs.

Trial ID:

2023-510439-13-00

Protocol code:

OCUS-Mode-CT-V1

Trial Phase:

Therapeutic confirmatory (Phase III)

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