NCT06996236

Brimonidine Eye Drops in the Prevention of Myopia Progression

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

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 receptors at a higher concentration via the topical route. This route of administration has been previously used in animal models and in humans, with atropine, pirenzepine and brimonidine. The concentration proposed (0.025%) in this study is the one used with relative success without side effects for atropine in humans, and has also been used in animal models for brimonidine itself. As this is a first study, the investigators do not propose the use of higher concentrations at this time. The proposed regimen (once a day) is the one commonly used in the treatment of myopia. Although at the concentration used it is used 3-4 times a day in other indications of brimonidine eye drops, given the longer duration of this treatment and the fact that it is a first study, the investigators opted for the once-daily regimen. Since eye growth is relatively slow, a treatment duration of 1 to 2 years is necessary to assess the effect of the drug on myopia progression and eye axial length variation. In addition, in case of therapeutic use of brimonidine eye drops, it would be necessary to use it for long periods of time, not less than 2 years, so it is convenient to evaluate its behavior when used in long term regimens.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	Treatment with brimonidine eye drops 0.025%	Treatment with brimonidine eye drops 0.025%, instilled once a day at night, with simultaneous occlusion of the lower lacrimal punctum to avoid its systemic absorption, for 2 years.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: Spain