Status:
NOT_YET_RECRUITING
Brimonidine Eye Drops in the Prevention of Myopia Progression
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
Myopia
Eligibility:
All Genders
6-14 years
Phase:
PHASE2
Brief 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...
Detailed Description
For the prevention of myopia progression it is reasonable to use a local topical route in eye drops, since it avoids the occurrence of systemic side effects and the drug reaches the corresponding rece...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06996236
Start Date
July 1 2025
End Date
July 1 2027
Last Update
May 30 2025
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28035