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Brimonidine eye drops in the prevention of myopia progression
EU CTIS ID: 2025-521878-33-00
What this study is testing
To determine the effect of brimonidine eye drops 0.025% on the progression of myopia in children aged 6 to 14 years. To determine the change in the refractive status of the eye 2 years after treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age from ≥ 6 to ≤ 14 years.
- Patients who, after being informed about the study design, the purposes of the study, the possible risks involved and that they may refuse to participate at any time, give their written consent to participate in the study (the patient over 12 years of age and the legal representative).
- Myopia ≥ -1.50 Diopters of spherical equivalent, with a range of -1.50 to -5.50 D
- Astigmatism with a cylinder power ≤ -1.50 Diopters
- Anisometropia (difference of refraction between both eyes) in spherical equivalent ≤ 1.25 Diopters
- Visual acuity (CVA) > 0.3 logMAR (0.5 on Snellen scale)
You likely can't join if
- Presence of any other ocular pathology (except myopia)
- History of allergy to the drugs and excipients used in the study
- History of previous therapy for myopia by means of eye drops, contact lenses or multifocal or bifocal glasses
- Amblyopia (2 or more lines of difference in visual acuity between both eyes, on logMAR scale, with optical correction)
- Any of the following situations present at the time: prolonged ocular hyperemia, prolonged ocular irritation, ocular infections - mucopurulent discharge in ocular tissues, ocular pain, vision changes/alterations other than myopia
- Any clinical situation that at the investigator's discretion makes participation inadvisable
See the full eligibility criteria
- Age from ≥ 6 to ≤ 14 years.
- Patients who, after being informed about the study design, the purposes of the study, the possible risks involved and that they may refuse to participate at any time, give their written consent to participate in the study (the patient over 12 years of age and the legal representative).
- Myopia ≥ -1.50 Diopters of spherical equivalent, with a range of -1.50 to -5.50 D
- Astigmatism with a cylinder power ≤ -1.50 Diopters
- Anisometropia (difference of refraction between both eyes) in spherical equivalent ≤ 1.25 Diopters
- Visual acuity (CVA) > 0.3 logMAR (0.5 on Snellen scale)
- Intraocular pressure < 20 mm Hg
- In women of childbearing age negative urine pregnancy test performed in the 7 days prior to the start of treatment
- Women and men of childbearing age with a partner must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives or hormonal contraceptive implants) and to continue using them until 6 months after the last dose of treatment.
- Presence of any other ocular pathology (except myopia)
- History of allergy to the drugs and excipients used in the study
- History of previous therapy for myopia by means of eye drops, contact lenses or multifocal or bifocal glasses
- Amblyopia (2 or more lines of difference in visual acuity between both eyes, on logMAR scale, with optical correction)
- Any of the following situations present at the time: prolonged ocular hyperemia, prolonged ocular irritation, ocular infections - mucopurulent discharge in ocular tissues, ocular pain, vision changes/alterations other than myopia
- Any clinical situation that at the investigator's discretion makes participation inadvisable
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.