ATROPINE SULFATE MONOHYDRATE for Myopia

Inclusion criteria

• {"criterion_text":"- Male and female subjects from 3 to less than 18 years of age.\n- Subjects showing myopia with a SER of both eyes at least -0.75 D at baseline.\n- Intraocular pressure ≤ 21 mm Hg in each eye.\n- Parents or legal representative who have been informed about the clinical trial and have signed the informed consent form, with the exception of subjects aged over 16 years only in the UK, who can provide their own consent, according to the local regulations.\n- Women with childbearing potential (WOCBP) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the clinical trials will be conducted at visits 1, 2, 3, 4, 5, 6.\n- WOCBP or males who are using a highly effective birth control method for contraception. Eligible highly effective contraceptive methods for WOCBP are combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system. Sexual abstinence represents a highly effective contraceptive method, if in line with the subject's normal habits."}

Exclusion criteria

• {"criterion_text":"- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding |1.5| D.\n- Refractive astigmatism (ΔTK) > |1.5| D.\n- Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.\n- History of amblyopia or strabismus.\n- Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)\n- Abnormal ocular biometry aside from axial length (e.g., keratoconus, lenticonus, spherophakia) or previous intraocular or ocular laser/non-laser surgery.\n- History of glaucoma; anatomic narrow anterior chamber angles.\n- Down syndrome or spastic paralysis.\n- Known intolerances/allergies against atropine eyedrops, or hypersensitivity to any component of the IMP.\n- Pregnancy or breastfeeding.\n- Previous or current alcohol or drug abuse.\n- Mental or emotional instability that might jeopardize the compliance with the trial procedures.\n- Unreliability or lack of cooperation.\n- History of any myopia control treatment within 3 months before inclusion: e.g. peripheral-plus or diffusion-optics-technology glasses, orthokeratology contact lenses, peripheral-plus/multifocal contact lenses, atropine eyedrops.\n- Other reasons why, in the opinion of the investigator, the subjects should not participate in the trial.\n- Patients who have consented to participate in the clinical trial, but do not meet one or more eligibility criteria required for participation in the trial during the screening procedures, and subsequently are not randomly assigned to the study treatment or entered in the study, are considered screening failures."}

Primary endpoints

• {"endpoint_text":"- Mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months.","definition_or_measurement_approach":"Based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months; reported as D/year (mean annual rate of progression)."}

Secondary endpoints

• {"endpoint_text":"- Number and percentage of early escape patients at 6 months.","definition_or_measurement_approach":"Counts and percentages of subjects meeting pre-specified criteria for early escape in the placebo group at month 6."}
• {"endpoint_text":"- Mean change in axial length and glasses prescription at 3, 6, 12, 18 and 24 months.","definition_or_measurement_approach":"Mean change from baseline in axial length and refractive prescription measured at specified visits (3,6,12,18,24 months)."}
• {"endpoint_text":"- Safety at 3, 6, 12, 18 and 24 months, measuring: % children requiring photochromic and/or varifocal lenses counts and percentage of patients reporting any AEs change in photosensitivity index best corrected distance and near visual acuity pupil size and accommodation amplitude","definition_or_measurement_approach":"Safety assessments include counts/percentages of AEs, proportion of children requiring photochromic/varifocal lenses, photosensitivity index changes, best corrected distance and near visual acuity, pupil size and accommodation amplitude at 3,6,12,18,24 months."}
• {"endpoint_text":"- Vision-related quality of life.","definition_or_measurement_approach":"Vision-related quality of life assessed at baseline, 6, 12 and 24 months (instrument not specified in the endpoint text)."}
• {"endpoint_text":"- Acceptability of the formulation: it will be assessed with a 3-item questionnaire, scored on a six-point scale.","definition_or_measurement_approach":"Acceptability assessed using a 3-item questionnaire scored on a six-point scale (formulation acceptability instrument described in protocol documents)."}
• {"endpoint_text":"- Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER) at 24 months: Chi-square test, or Fisher's exact test, will be used to test for differences among three treatment groups in the proportion of subjects who show < -0.50 D myopia progression (SER) at 24 months.","definition_or_measurement_approach":"Proportion of subjects with < -0.50 D SER progression at 24 months; between-group differences tested with Chi-square or Fisher's exact test."}

Methods

• Social media posts (Social Media Post text documents present for Italy, Spain and Poland) — channel: social media; target audience: parents/guardians of eligible children and adolescents; country-specific materials available.
• Posters (POSTER documents present for Italy, Spain and Poland) — channel: clinic/hospital/community posters; target audience: families and potential participants; country-specific materials available.
• Brochures (BROCHURE documents present for Italy, Spain and Poland) — channel: printed/printable brochures for distribution at sites; target audience: parents/guardians and potential participants; country-specific materials available.
• Local recruitment arrangements documents (K1_Recruitment arrangements) for Italy, Spain and Poland — likely site-level recruitment procedures and contact information.

Italy

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

459

Number Of Sites

3

Number Of Participants

54

Spain

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

03-03-2026

Processing Time Days

484

Number Of Sites

3

Number Of Participants

46

Poland

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

526

Number Of Sites

1

Number Of Participants

37

Primary sponsor

Full Name

Ocus Innovation Ireland Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Third parties

• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"Codes: 1,10,11,12,13,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Albania","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"Codes: 11,12,13,5","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Euromed Pharma Services S.r.l.","duties_or_roles":"Codes: 14","organisation_type":"Pharmaceutical company"}