Brimonidine Eye Drops in the Prevention of Myopia Progression

ConditionMyopia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-14
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Lumobry 0.25 mg/ml eye drops solutionActive comparator 1 intervention

Trial outcomes

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)

Time frame
24 months

Secondary outcomes

1

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

Time frame
24 months
2

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

Time frame
24 months
3

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

Time frame
24 Months
4

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

Time frame
24 Months

Other outcomes

Sponsors and contacts

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