Study on Brimonidine Eye Drops to Prevent Myopia Progression in Children Aged 6 to 14 Years

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What is this study about?

This study aims to assess the effect of brimonidine eye drops 0.025% on the progression of myopia (nearsightedness) in children. Myopia is a common vision condition where close objects appear clear, but distant objects appear blurry. The purpose is to determine how brimonidine eye drops affect the progression of myopia over a two-year period and measure changes in the refractive status of the eye.

The research involves children aged 6 to 14 years who have myopia of at least -1.50 diopters (a unit of measurement for the focusing power of the eye). During the study, participants will receive brimonidine eye drops, and their eye measurements will be taken every six months to track any changes in their vision. These measurements include the axial length (the distance from the front to the back of the eye), visual acuity (sharpness of vision), and other eye characteristics.

The study will monitor various aspects of eye health including pupillometry (measurement of pupil size under different lighting conditions), accommodation (how well the eye adjusts focus), corneal topography (mapping the surface curvature of the cornea), and intraocular pressure (pressure inside the eye). Throughout the study, safety will be assessed by collecting information about any adverse events.

1 Initial Assessment

You will undergo a comprehensive eye examination to confirm your eligibility for the study. This will include measuring your myopia (nearsightedness) level, which must be between -1.50 and -5.50 diopters.

The examination will also check your astigmatism (must be ≤ -1.50 diopters), anisometropia (difference between both eyes must be ≤ 1.25 diopters), visual acuity, and intraocular pressure (must be < 20 mm Hg).

Various measurements will be taken including your pupil size under different lighting conditions, corneal topography (mapping of your cornea), and accommodation (how your eye focuses).

2 Treatment Start

You will begin using brimonidine eye drops 0.025% (Lumobry 0.25 mg/ml) as prescribed. The exact dosing schedule will be explained by your doctor.

These eye drops are being tested to determine if they can slow down the progression of myopia in children aged 6 to 14 years.

3 Follow-up Visits Every 6 Months

You will need to return for check-ups every 6 months during the 2-year study period.

At each visit, your myopia progression will be measured (changes in your refractive error).

Other measurements will include the axial length of your eye (the distance from front to back of the eye), visual acuity for both distance and near vision, and intraocular pressure.

Your accommodation ability and pupil responses will also be assessed at these visits.

Any side effects or safety concerns will be recorded during these check-ups.

4 Final Assessment

After 2 years of treatment, a final comprehensive eye examination will be conducted.

This will measure the overall change in your refractive status (how your myopia has or hasn’t progressed).

All the same measurements from previous visits will be taken to compare with your starting condition.

The effectiveness of the brimonidine eye drops in preventing myopia progression will be evaluated based on these results.

5 Continuation of Care

After completing the 2-year study period, your doctor will discuss the results with you and recommend appropriate next steps for your eye care.

If you experienced any continuing side effects, these will be monitored until resolved.

Who Can Join the Study?

Between 6 and 14 years old
The patient (if over 12 years old) and their legal representative must give written consent after being informed about the study
Have myopia (nearsightedness) of at least -1.50 diopters but not more than -5.50 diopters
Have astigmatism (irregular curvature of the eye) not exceeding -1.50 diopters
The difference in prescription between both eyes must not exceed 1.25 diopters
Visual acuity (sharpness of vision) better than 0.3 logMAR (or 0.5 on Snellen scale, which is the standard eye chart)
Intraocular pressure (pressure inside the eye) less than 20 mm Hg
Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
Women and men who can have children and are in a relationship must agree to use effective birth control methods until 6 months after the last treatment

Who Cannot Join the Study?

Children who are younger than 6 years or older than 14 years
Children with a history of wearing bifocal or multifocal glasses (glasses with different lens powers for seeing at different distances)
Children who have used atropine eye drops (medication that dilates the pupil) for myopia (nearsightedness) in the past
Children with a history of using contact lenses
Children who have abnormal eye development or eye diseases other than myopia
Children with a history of eye surgery
Children with known allergies to brimonidine (the study medication) or its components
Children with heart or blood vessel diseases
Children with kidney or liver problems
Children with certain brain disorders
Children taking medications that could interact with brimonidine
Children who are participating in other clinical trials

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Brimonidine Tartrate

Brimonidine eye drops
Brimonidine is a medication that comes in the form of eye drops. In this study, it is being tested to see if it can help slow down the progression of myopia (nearsightedness) in children. Myopia is a condition where distant objects appear blurry. Brimonidine works by affecting certain receptors in the eye, which may influence how the eye grows and develops.

Investigated diseases:

Myopia

Myopia is a refractive error of the eye that causes distant objects to appear blurry while near objects can be seen clearly, commonly known as nearsightedness. It occurs when the eyeball grows too long from front to back, or when the cornea or lens is too curved, causing light rays to focus in front of the retina rather than directly on it. In children, myopia typically begins between ages 6 and 14 and can progressively worsen throughout childhood and adolescence as the eyeball continues to grow. The condition is measured by spherical equivalent of refractive error, with higher negative numbers indicating more severe myopia. As myopia progresses, the axial length of the eye increases, which is a key measurement in monitoring the condition’s advancement. Without intervention, progressive myopia can lead to increased risk of various eye conditions in adulthood.

Trial ID:

2025-521878-33-00

Protocol code:

BPM2024

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Brimonidine Eye Drops to Prevent Myopia Progression in Children Aged 6 to 14 Years

What is this study about?

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Who Cannot Join the Study?