Brimonidine Eye Drops in the Prevention of Myopia Progression

Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study ID
NCT06996236
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment with brimonidine eye drops 0.025% — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 30, 2025
Start date
Jul 31, 2025
Status verified
May 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Active Comparator: Lumobry 0.25 mg/ml eye drops solution
    Lumobry 0.25 mg/ml eye drops solution

Primary Outcome Measure

Effect of brimonidine eye drops 0.025% on myopia progression in children aged 6 to 14 years [ Time Frame: 24 months ]

Central Contacts

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