Brimonidine Eye Drops to Slow Myopia in Kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial tests 0.025% brimonidine eye drops given once daily for 1–2 years to see if it slows the growth of the eye and progression of myopia in children. The study uses a local eye-drop delivery to minimize systemic effects and focuses on a regimen similar to other myopia treatments. Participants will have specific refractive, visual, and safety criteria and will be monitored for changes in axial length and vision over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 6 to ≤ 14 years
* Patients who, after having received information about the design, the purposes of the study, the possible risks that may arise from it and that at any time they may refuse to cooperate, give written consent to participate in the study (the patient older than 12 years and the legal representative)
* Myopia ≥ -1. 50 Diopters of spherical equivalent, ranging from -1.50 to -5.50 D
* Astigmatism with a cylinder power ≤ -1.50 Diopters
* Anisometropia (refractive difference 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 within 7 days prior to the start of treatment
* Women and men with partners of childbearing age 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.

Exclusion Criteria:

* Presence of any other ocular pathology (other than myopia)
* History of allergy to the medications and excipients used in the study
* History of previous therapy for myopia using 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 advises against participation.

Where it's running

• Hospital Universitario Ramón y Cajal
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Jaime Tejedor Fraile, MD — Hospital Universitario Ramon y Cajal
• Study coordinator: Jaime Tejedor Fraile, Md
• Email: tejedor.jaime@gmail.com
• Phone: 913368679 / 913369023

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.