Brimonidine eye drops in the prevention of myopia progression

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Ocular Physiological Phenomena [G14]

Trial duration

10 Dec 2025 → ongoing

Decision date (initial)

2025-07-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine the effect of brimonidine eye drops 0.025% on the progression of myopia in children aged 6 to 14 years. To determine the change in the refractive status of the eye 2 years after treatment.

Secondary objectives 1

1. To determine the progression of various ocular biometric variables in the children of the treated and control groups, especially axial length; other variables of interest are the potential effect on pupil size and, more remotely, on accommodation. Determine the change in axial eye length 2 years after treatment.

Conditions and MedDRA coding

Myopia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age from ≥ 6 to ≤ 14 years.
2. Patients who, after being informed about the study design, the purposes of the study, the possible risks involved and that they may refuse to participate at any time, give their written consent to participate in the study (the patient over 12 years of age and the legal representative).
3. Myopia ≥ -1.50 Diopters of spherical equivalent, with a range of -1.50 to -5.50 D
4. Astigmatism with a cylinder power ≤ -1.50 Diopters
5. Anisometropia (difference of refraction between both eyes) in spherical equivalent ≤ 1.25 Diopters
6. Visual acuity (CVA) > 0.3 logMAR (0.5 on Snellen scale)
7. Intraocular pressure < 20 mm Hg
8. In women of childbearing age negative urine pregnancy test performed in the 7 days prior to the start of treatment
9. Women and men of childbearing age with a partner 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 criteria 6

1. Presence of any other ocular pathology (except myopia)
2. History of allergy to the drugs and excipients used in the study
3. History of previous therapy for myopia by means of eye drops, contact lenses or multifocal or bifocal glasses
4. Amblyopia (2 or more lines of difference in visual acuity between both eyes, on logMAR scale, with optical correction)
5. 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
6. Any clinical situation that at the investigator's discretion makes participation inadvisable

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Myopia progression (change in spherical equivalent of refractive error) measured every 6 months

Secondary endpoints 8

1. Change in axial length of the eye; axial length to corneal radius ratio (related to type of refractive error or myopia classification and risk of progression)
2. Visual acuity (logMAR scale) for distance and near vision
3. Stereo acuity by Randot circles / Randot preschool chart (initial visit only) in arc seconds (will be converted to logarithmic scale for statistical use of the variable).
4. Pupillometry/accommodation (Power Refractor III) Pupillometry in mm, under scotopic (< 1 cd/m2), mesopic (2-3 cd/m2) and photopic (10-20 cd/m2) conditions, using Power Refractor 3
5. Corneal topography with Oculus Pentacam elevation topographer.
6. Accommodation (amplitude of accommodation in diopters and accommodative gain resulting from the ratio of accommodation required/accommodation achieved or realized) with Power Refractor 3
7. Intraocular pressure with air tonometer (non-contact) Tonoref III (Nidek), unless it is necessary to use the applanation tonometer, in inconclusive cases; measured in mm Hg-.
8. Safety: collection of adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Address

Carretera Del Colmenar Viejo Km 9100, Por El Pardo Por El Pardo

City

Madrid

Postcode

28034

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Contact name

Itziar de Pablo Lopez de Abechuco

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Contact name

Itziar de Pablo Lopez de Abechuco

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications