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NCT06996236
Brimonidine Eye Drops in the Prevention of Myopia Progression
Conditions: Myopia
Sex: All
Ages: 6 Years – 14 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Location: Hospital Universitario Ramón y Cajal Madrid Madrid
Summary
Study to determine the efficacy of alpha-2 adrenergic drugs (brimonidine) in the prevention of myopia progression. Given that the drugs used so far have limited efficacy and side effects (loss of near vision, photophobia), it may be an interesting contribution to such treatment at low cost, and to avoid the expense of managing the complications of myopia that develop throughout life.
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.
Source: ClinicalTrials.gov (NCT06996236). StuddyBuddy aggregates publicly available trial information.