Brimonidine Eye Drops in the Prevention of Myopia Progression

NCT06996236 | Not Yet Recruiting Phase 2

• 1 other identifier: BPM2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Effect of brimonidine eye drops 0.025% on myopia progression in children aged 6 to 14 years

  Progression of myopia (change in spherical equivalent of refractive error) measured every 6 months (Auto-refractometry and Subjective refraction)

  24 months

Secondary Outcomes (6)

• Progression of various ocular biometric variables in the children of the treated and control groups,

  24 months

• Progression of various ocular biometric variables in the children of the treated and control groups

  24 months

• Progression of various ocular biometric variables in the children of the treated and control groups

  24 Months

• Progression of various ocular biometric variables in the children of the treated and control groups

  24 Months

• Progression of various ocular biometric variables in the children of the treated and control groups

  24 Months

Study Arms (1)

Lumobry 0.25 mg/ml eye drops solution

ACTIVE COMPARATOR

Lumobry 0.25 mg/ml eye drops solution

Drug: Treatment with brimonidine eye drops 0.025%

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.

Lumobry 0.25 mg/ml eye drops solution

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28035, Spain

Location

MeSH Terms

Conditions

Myopia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jaime Tejedor Fraile, Md

CONTACT

913368679 / 913369023; tejedor.jaime@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 30, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

ES (1)