MyopiaPhase 2NCT06996236
Brimonidine Eye Drops in the Prevention of Myopia Progression
A Phase 2 study testing Treatment with brimonidine eye drops 0.025% in people with Myopia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Myopia
- What is being tested?
- Treatment with brimonidine eye drops 0.025%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2025to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28035
Jaime Tejedor Fraile, Md, 913368679 / 913369023, tejedor.jaime@gmail.com
About this study
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.
Read the 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
- Being tested
- Treatment with brimonidine eye drops 0.025%
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Lumobry 0.25 mg/ml eye drops solution | Active comparator | Lumobry 0.25 mg/ml eye drops solution Receives: Drug: Treatment with brimonidine eye drops 0.025% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
Secondary outcomes (6)
Progression of various ocular biometric variables in the children of the treated and control groups,
Myopia progression by measuring every 6 months: change in axial eye length
Measured: 24 months
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: visual acuity
Measured: 24 months
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: pupillometry/accommodation
Measured: 24 Months
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: corneal topography
Measured: 24 Months
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: intraocular pressure
Measured: 24 Months
Progression of various ocular biometric variables in the children of the treated and control groups
Collecting adverse events
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996236
- Sponsor's protocol ID
- BPM2024
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brimonidine Eye Drops in the Prevention of Myopia Progression
- ClinicalTrials.gov ID
- NCT06996236
- Acronym / sponsor ID
- BPM2024
- Conditions
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumobry 0.25 mg/ml eye drops solution | Active comparator | Drug: Treatment with brimonidine eye drops 0.025%Lumobry 0.25 mg/ml eye drops solution |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Lumobry 0.25 mg/ml eye drops solution |
Primary outcome
Effect of brimonidine eye drops 0.025% on myopia progression in children aged 6 to 14 years
Time frame: 24 months
Progression of myopia (change in spherical equivalent of refractive error) measured every 6 months (Auto-refractometry and Subjective refraction)
6 secondary outcomes
Progression of various ocular biometric variables in the children of the treated and control groups,
Time frame: 24 months
Progression of various ocular biometric variables in the children of the treated and control groups
Time frame: 24 months
Progression of various ocular biometric variables in the children of the treated and control groups
Time frame: 24 Months
Progression of various ocular biometric variables in the children of the treated and control groups
Time frame: 24 Months
Progression of various ocular biometric variables in the children of the treated and control groups
Time frame: 24 Months
Progression of various ocular biometric variables in the children of the treated and control groups
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment with brimonidine eye drops 0.025% in people with Myopia, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaime Tejedor Fraile, Md (913368679 / 913369023, tejedor.jaime@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of brimonidine eye drops 0.025% on myopia progression in children aged 6 to 14 years (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.