Myopia in children
Conditions
Interventions
Product Name: Atropini collyrium 0.02%
Pharmaceutical Form: Eye drops
INN or Proposed INN: ATROPINE SULFATE
CAS Number: 55-48-1
Concentration unit: % (W/W) percent weight/weight
Concentration type: eq
Sponsors
Fakultní nemocnice Brno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 6-12 years 2) 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 3) BCDVA of worse eye better or equal to 0.2 logMAR (according to ETDRS test, 85 cd / m2) 4) Corneal topography index (anterior corneal area): KI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) General diseases, that can lead to myopia (Marfan's, Stickler's syndrome) or affect visual functions (diabetes mellitus, chromosomal anomalies) 2) Previous pharmacological, surgical and/or orthokeratological therapy of myopia 3) Previous long-term treatment with atropine (e.g. longer than 14 days) 4) Presence and/or history of allergic reaction to ophthalmologics (atropine; cycloplegics - cyclopentolate, tropicamide; local anesthetics - eg oxybuprocaine, etc.) 5) Presence of strabism, amblyopia, glaucoma, corneal damage and/or corneal scarring and current and/or previous ocular conservative, contactology and/or surgical therapy 6) Presence and/or history of general disease (incl. allergy, myasthenia gravis, cardiac, respiratory and/or renal-urological disease and/or dysfunction) 7) 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 8) Concomitant use of monoamine oxidase inhibitors (MAOIs) 9) Pregnancy, ev. breast feeding 10) Presence of rhinitis sicca
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Secondary objectives in relation to efficiency: • Difference of AXL over 12M administration period with 0,04% atropine versus placebo, with 0,02% atropine versus 0,04% atropine • Difference in AXL over 24M administration period with 0,02% and 0,04% atropine versus placebo and mutually • Rebound phenomenon in both active arms (0,02% and 0,04%) in period 24M-36M versus placebo and mutually • Cycloplaegic spherical equivalent refraction (SER) difference for 12M administration period (0,02%, 0,04% versus placebo and mutually) • Cyloplaegic SER difference for 24M administration period (0,02% and 0,04% versus placebo and mutually) • Difference AXL/CR index for 12M administration period (0,02% and 0,04% versus placebo and mutually) • Difference AXL/CR index for 24M administration period (0,02% and 0,04% versus placebo and mutually) • Visual functional characteristics (BCDVA-best corrected distance visual acuity;BCNVA-best corrected near visual acuity;contrast sensitivity;colour perception);Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 12 M | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives in relation to efficiency: • Difference of AXL over 12M administration period with 0,04% atropine versus placebo • Difference of AXL over 12M administration period with 0,02% atropine versus 0,04% • Difference in AXL over 24M administration period with 0,02% and 0,04% atropine versus placebo and mutually • Rebound phenomenon in both active arms (0,02% and 0,04%) in the period 24M - 36M against placebo and mutually • Cycloplaegic spherical equivalent refraction (SER) difference for 12M administration period (0,02% and 0,04% versus placebo and mutually) • Cyloplaegic SER difference for 24M administration period (0,02% and 0,04% versus placebo and mutually) • Difference AXL / CR index for 12M administration period (0,02% and 0,04% against placebo and mutually) • Difference of AXL / CR index for 24M administration period (0,02% and 0,04% against placebo and mutually) • Visual functional characteristics (BCDVA - best corrected distance visual acuity; BCNVA - best corrected near visual acuity; contrast sensitivity; colour perception) Secondary objectives related to the mechanism of origin and development of the disease: • Other growth characteristics of the eye (anterior segment biometry: corneal topography and keratometry, anterior chamber, lens thickness, horizontal anterior chamber dimension (WTW); choroidal thickness) • Functional characteristics of the eye (NPA - near-point of accommodation; NPC - near point of convergence; facility of accommodation)) • SE peripheral defocus • Influence of genetic predisposition (parental refractive error, body height and BMI) • Influence of lifestyle (living outside, close work including technologies) Secondary objectives related to safety and tolerability of treatment: • The intensity, severity and frequency of all side effects - Systemic (heart rate and other reported adverse events) - Ophthalmological TRAE - Subjects' visual comfort - Ret | — |
Countries
Czech Republic
Contacts
Public ContactCentrum pro klinická hodnocení
Masarykova univerzita - Lékarská fakulta
Outcome results
None listed