Brimonidine tartrate for Myopia

Inclusion criteria

• {"criterion_text":"- Age from ≥ 6 to ≤ 14 years.\n- 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).\n- Myopia ≥ -1.50 Diopters of spherical equivalent, with a range of -1.50 to -5.50 D\n- Astigmatism with a cylinder power ≤ -1.50 Diopters\n- Anisometropia (difference of refraction between both eyes) in spherical equivalent ≤ 1.25 Diopters\n- Visual acuity (CVA) > 0.3 logMAR (0.5 on Snellen scale)\n- Intraocular pressure < 20 mm Hg\n- In women of childbearing age negative urine pregnancy test performed in the 7 days prior to the start of treatment\n- 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

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

Primary endpoints

• {"endpoint_text":"- Myopia progression (change in spherical equivalent of refractive error) measured every 6 months","definition_or_measurement_approach":"Change in spherical equivalent of refractive error measured every 6 months"}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Axial length change and axial length/corneal radius ratio (measurement method not further specified)"}
• {"endpoint_text":"- Visual acuity (logMAR scale) for distance and near vision","definition_or_measurement_approach":"Visual acuity measured on logMAR scale for distance and near"}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Stereo acuity measured with Randot circles / Randot preschool chart in arc seconds; converted to logarithmic scale for analysis"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Pupillometry measured in mm under specified lighting conditions using Power Refractor 3; accommodation assessed with Power Refractor III"}
• {"endpoint_text":"- Corneal topography with Oculus Pentacam elevation topographer.","definition_or_measurement_approach":"Corneal topography obtained using Oculus Pentacam elevation topographer"}
• {"endpoint_text":"- Accommodation (amplitude of accommodation in diopters and accommodative gain resulting from the ratio of accommodation required/accommodation achieved or realized) with Power Refractor 3","definition_or_measurement_approach":"Amplitude of accommodation in diopters and accommodative gain measured with Power Refractor 3"}
• {"endpoint_text":"- 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-.","definition_or_measurement_approach":"Intraocular pressure measured in mm Hg using Tonoref III (non-contact); applanation tonometer used if needed"}
• {"endpoint_text":"- Safety: collection of adverse events","definition_or_measurement_approach":"Collection and recording of adverse events (safety monitoring)"}

Spain

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

25

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain