Clinical trial • Phase IV • Ophthalmology
ATROPINE SULFATE for Myopia
Phase IV trial of ATROPINE SULFATE for Myopia.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Myopia
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-07-2024
- First CTIS Authorization Date
- 02-08-2024
Trial design
Randomised, atropine eye drops 0.5% versus atropine eye drops 0.05% (comparison of two active treatment arms; schedule/dosing frequency not specified in the record).-controlled Phase IV trial across 21 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Atropine eye drops 0.5% versus atropine eye drops 0.05% (comparison of two active treatment arms; schedule/dosing frequency not specified in the record).
- Target Sample Size
- 550
Eligibility
Recruits 550 paediatric patients.
- Vulnerable Population
- Children aged 6 to ≤11 years are included. Subject information and informed consent documents are listed for children and parents (titles include: 'L1 SIS and ICF children until 12 years MAD V2_0 14Nov2022', 'L1 SIS and ICF children-12-to-16-years_MAD V2 14NOv2022', and 'L1 SIS and ICF parents MAD V2_1 09-10-2023 clean'). Parent ICF and child SIS/ICF documents are provided, indicating parental consent and child information/assent procedures are addressed.
Inclusion criteria
- {"criterion_text":"- Children aged 6 to ≤ 11 years with bilateral myopia\n- Onset of myopia ≥ 4 years of age\n- History of myopia progression.\n- SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction\n- Intraocular pressure < 21 mm Hg in each eye"}
Exclusion criteria
- {"criterion_text":"- Allergy to atropine\n- History of amblyopia or strabismus, glaucoma or retinal dystrophy or systemic disorder that predisposes to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity).\n- Prior myopia control treatment (Atropine, ortho-keratology, multifocal contact lenses\n- Glaucoma"}
Endpoints
Primary endpoints
- {"endpoint_text":"- To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of AL in children with progressive myopia.","definition_or_measurement_approach":"Progression of AL (axial length) in children with progressive myopia. Exact measurement method not specified in the record."}
Secondary endpoints
- {"endpoint_text":"- To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of SER (Spherical Equivalent of Refraction) in children with progressive myopia.","definition_or_measurement_approach":"Progression of SER (Spherical Equivalent of Refraction). Exact measurement method not specified in the record."}
- {"endpoint_text":"- To evaluate the safety, adherence, and reasons for nonresponse of atropine 0.05% compared to atropine 0.5% treatment","definition_or_measurement_approach":"Safety and adherence to be evaluated; methods not specified in the record."}
- {"endpoint_text":"- To evaluate the rebound effect after treatment-stop.","definition_or_measurement_approach":"Rebound effect after treatment cessation to be evaluated; measurement approach not specified in the record."}
Recruitment
- Planned Sample Size
- 550
- Recruitment Window Months
- 97
- Consent Approach
- Parent informed consent and child information/consent forms are provided. Documents in the record include 'L1 SIS and ICF children until 12 years', 'L1 SIS and ICF children-12-to-16-years', and 'L1 SIS and ICF parents MAD V2_1 09-10-2023 clean'. A Dutch translation/language version is present in the record. Contact details for the trial bureau (mad@erasmusmc.nl) are provided.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 550
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 501
- Number Of Sites
- 21
- Number Of Participants
- 550
Sites
- Site Name
- Oogkliniek Den Haag
- Department Name
- Ophthalmology
- Contact Person Name
- m Vermeulen
- Contact Person Email
- info@oogkliniekdenhaag.nl
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Ophthalmology
- Contact Person Name
- Caroline Klaver
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Ophthalmology
- Contact Person Name
- S.S. Boekhoorn
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Ziekenhuis Rivierenland
- Department Name
- Ophthalmology
- Contact Person Name
- l Hazeleger
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Oogcentrum NH
- Department Name
- Ophthalmology
- Contact Person Name
- A Heemskerk
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Haga Hospital
- Department Name
- Ophthalmology
- Contact Person Name
- m de Jong
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Stichting Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Ophthalmology
- Contact Person Name
- i Donkers
- Contact Person Email
- wetenschapsbureau@etz.nl
- Site Name
- Flevoziekenhuis Stichting
- Department Name
- Ophthalmology
- Contact Person Name
- D Laan
- Contact Person Email
- wetenschapsbureau@flevoziekenhuis.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Ophthalmology
- Contact Person Name
- N Schalij
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Martini Ziekenhuis
- Department Name
- Ophthalmology
- Contact Person Name
- J Tideman
- Contact Person Email
- w.tideman@mzh.nl
- Site Name
- Oogartsenpraktijk Delfland
- Department Name
- Ophthalmology
- Contact Person Name
- A van der Schans
- Contact Person Email
- info@OAPD.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Ophthalmology
- Contact Person Name
- Sjoukje Loudon
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Ophthalmology
- Contact Person Name
- l de Jong
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Ophthalmology
- Contact Person Name
- E Abma
- Contact Person Email
- wetenschapsbureau@rdgg.nl
- Site Name
- Stichting OLVG
- Department Name
- Ophthalmology
- Contact Person Name
- A. Schermer
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Deventer Ziekenhuis
- Department Name
- Ophthalmology
- Contact Person Name
- M Bartels
- Contact Person Email
- wetenschapsbureau@dz.nl
- Site Name
- Maastricht University Medical Center+
- Department Name
- Ophthalmology
- Contact Person Name
- N Bauer
- Contact Person Email
- n.bauer@mumc.nl
- Site Name
- Admiraal De Ruyter Ziekenhuis B.V.
- Department Name
- Ophthalmology
- Contact Person Name
- j de Geus
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Bergman Clinics Nederland B.V.
- Department Name
- Ophthalmology
- Contact Person Name
- M de Graaf
- Contact Person Email
- mad@erasmusmc.nl
- Site Name
- Oogkliniek Drechtsteden
- Department Name
- Ophthalmology
- Contact Person Name
- Marloes Veenvliet
- Contact Person Email
- info@oogkliniekdrechtsteden.nl
- Site Name
- Frisius
- Department Name
- Ophthalmology
- Contact Person Name
- j Fonk
- Contact Person Email
- mad@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Atropine 1.0% eye drops solution (used diluted to 0.5% and 0.05% in the trial)
- Active Substance
- ATROPINE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- OCULAR
- Route
- Ocular (eye drops)
- Authorisation Status
- Marketing authorisation PL 45043/0132 (authorisation country code GB)
- Starting Dose
- 0.5% and 0.05% (trial compares these concentrations; product is 1.0% diluted to these concentrations)
- Dose Levels
- 0.5% and 0.05%
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