Brimonidine Eye Drops in the Prevention of Myopia Progression

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of brimonidine eye drops to help slow down the worsening of myopia, also known as nearsightedness, in children and teenagers. Myopia can lead to more serious eye problems later in life, and current treatments have limited effectiveness and can cause side effects, like trouble seeing up close. By testing brimonidine, researchers hope to find a more effective and affordable way to manage myopia and its complications.

To be eligible for this study, participants must be between 6 and 14 years old and have myopia ranging from -1.50 to -5.50 diopters, which is a measure of how nearsighted they are. They should also not have any other eye diseases or a history of certain myopia treatments. If a child is chosen to participate, they will receive information about the study and must agree to take part. Throughout the trial, participants will be monitored for any side effects and overall progress in their vision. This trial is not yet recruiting, but it aims to offer a new option for young people struggling with myopia.

Gender

ALL

Eligibility criteria

• 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.