ATROPINE SULFATE MONOHYDRATE for Myopia

Inclusion criteria

• {"criterion_text":"- Age 6-12 years\n- Diagnosis of myopia - spherical component of refraction -0.5 Dsf to - 4.75 Dsf and astigmatism 0 to -2.5 Dcyl at least on one of the eyes\n- BCDVA of worse eye better or equal to 0.2 logMAR (according to ETDRS test, 85 cd / m2)\n- Corneal topography index (anterior corneal area): KI < 1,07, ISV < 37 at least on one of the eyes\n- Normal ocular finding and history in both eyes (except for spectacle correction and banal eye diseases, eg history of acute conjunctivitis, lacrimal lavage in early childhood)\n- Normal binocular functions in both eyes (in sensory and motor components) with the exception of exophoria equal to or more than 8 Dp incl. in an alternating covering test with prisms\n- Normal intraocular pressure (≤ 22 torr, contactless applanation) in both eyes\n- Fulfillment of the indication criterion of AXL growth in 6-8M in 9M observation period before enrollment to the study according to the data in the patient medical documentation in at least on one of the eyes: Age AXL growth in 6M AXL growth in 7M AXL growth in 8M 6-7 years, 0.10 mm 0.11 mm 0.12 mm 8-9 years, 0.11 mm 0.12 mm 0.13 mm 10-11 years, 0.12 mm 0.13 mm 0.14 mm\n- The willingness of the patient and his / her parents / legal guardian to undergo a two-year period of daily application of eye drops, a threeyear period of clinical examinations every six months and weekly keeping of diary entries during this period."}

Exclusion criteria

• {"criterion_text":"- Previous pharmacological, surgical and / or orthokeratological therapy of myopia\n- Presence of rhinitis sicca\n- Previous long-term treatment with atropine\n- Presence and / or history of allergic reaction to ophthalmologics (atropine; cycloplegics - cyclopentolate, tropicamide; local anesthetics - eg oxybuprocaine, etc.)\n- Presence of strabism, amblyopia, glaucoma, corneal damage and / or corneal scarring and current and / or previous ocular conservative, contactology and / or surgical therapy\n- Presence and / or history of general disease (incl. allergy, myasthenia gravis, cardiac, respiratory and / or renal-urological disease and / or dysfunction)\n- Presence or scheduled launch of long-term (i.e. longer than 14 days) general and/or local drug therapy and/or scheduled surgical therapy for the participation in the study\n- Concomitant use of monoamine oxidase inhibitors (MAOIs)\n- Pregnancy, ev. breast feeding\n- General diseases, that can lead to myopia (Marfan's, Stickler's syndrome) or affect visual functions (diabetes mellitus, chromosomal anomalies)"}

Primary endpoints

• {"endpoint_text":"- The primary objective of the clinical trial is to determine the difference in axial eye length (AXL) over a 12M application period with 0,02% atropine versus placebo.","definition_or_measurement_approach":"Difference in axial eye length (AXL) measured over a 12-month application period comparing 0.02% atropine versus placebo (AXL measurement as stated in the primary objective/endpoint)."}

Secondary endpoints

• {"endpoint_text":"- Difference of AXL over 12M administration period with 0,04% atropine versus placebo\n- Difference of AXL over 12M administration period with 0,02% atropine versus 0,04%\n- Difference in AXL over 24M administration period with 0,02% and 0,04% atropine versus placebo and mutually\n- Rebound phenomenon in both active arms (0,02% and 0,04%) in the period 24M - 36M against placebo and mutually\n- Cycloplaegic spherical equivalent refraction (SER) difference for 12M administration period (0,02% and 0,04% versus placebo and mutually)\n- Cyloplaegic SER difference for 24M administration period (0,02% and 0,04% versus placebo and mutually)\n- Difference AXL / CR index for 12M administration period (0,02% and 0,04% against placebo and mutually)\n- Difference of AXL / CR index for 24M administration period (0,02% and 0,04% against placebo and mutually)\n- Visual functional characteristics (BCDVA - best corrected distance visual acuity; BCNVA - best corrected near visual acuity; contrast sensitivity; colour perception)\n- Other growth characteristics of the eye (anterior segment biometry: corneal topography and keratometry, anterior chamber, lens thickness, horizontal anterior chamber dimension (WTW); choroidal thickness)\n- Functional characteristics of the eye (NPA - near-point of accommodation; NPC - near point of convergence; facility of accommodation))\n- SE peripheral defocus\n- Influence of genetic predisposition (parental refractive error, body height and BMI)\n- Influence of lifestyle (living outside, close work including technologies)\n- The intensity, severity and frequency of all side effects - Systemic (heart rate and other reported adverse events) - Ophthalmological TRAE - Subjects' visual comfort - Retinal vascular change,RNFL - retinal layers of nerve fibers, intraocular pressure, iris colour - Static photoreaction (photopic and [scotopic] mesopic pupil diameter) - NPA, NPC and facility of accommodation - Corneal and conjunctival irritation (Oxford fluorescein test)\n- Compliance stated by the patient (or parents, legal representative)\n- Quality of life and discomfort associated with therapy: self-assessment of younger patients\n- Impact of atropine therapy on quality of life (ATI Pediatric Eye Disease Investigator Group [PEDIG]) assessed by patient and parents / legal guardian","definition_or_measurement_approach":"Secondary endpoints specify differences in axial eye length (AXL) and spherical equivalent refraction (SER) over 12M and 24M periods between arms, rebound in 24M-36M, a range of ocular biometric and functional measures (BCDVA, BCNVA, contrast sensitivity, choroidal thickness, keratometry, NPA, NPC, SE peripheral defocus), safety and adverse event assessments (systemic and ophthalmological TRAE, retinal and RNFL measures, intraocular pressure, pupil diameter), compliance and quality-of-life measures (including PEDIG questionnaire). Timepoints and comparisons are described in each endpoint statement."}

Methods

• Site-based recruitment at participating ophthalmology clinics listed in the trial (e.g. Vseobecna Fakultni Nemocnice V Praze; Binocular s.r.o.; Fakultni Nemocnice Brno; Fakultni Nemocnice V Motole; Fakultni Nemocnice Kralovske Vinohrady).
• Use of recruitment arrangements document ('Sablona 1 Nabor subjektu').
• Information materials/leaflets for primary care paediatricians ('Informacni letak pro PLDD') and subject information/informed consent forms for parents and children (documents present in trial documents).

Czechia

Earliest CTIS Part Ii Submission Date

26-06-2024

Latest Decision Or Authorization Date

10-04-2025

Processing Time Days

288

Number Of Sites

5

Number Of Participants

237

Primary sponsor

Full Name

Fakultni Nemocnice Brno

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"Czechia","full_name":"Masarykova Univerzita","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,5,6,8","organisation_type":"Educational Institution"}