Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
550
Countries
1
Sites
21
Myopia
To compare the efficacy of atropine 0.05% to atropine 0.5% treatment in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 2 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516379-34-00
- EudraCT number
- 2021-004015-11
- ClinicalTrials.gov
- NCT05667454
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare the efficacy of atropine 0.05% to atropine 0.5% treatment in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse.
Conditions and MedDRA coding
Myopia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Children aged 6 to ≤ 11 years with bilateral myopia
- Onset of myopia ≥ 4 years of age
- History of myopia progression.
- SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
- Intraocular pressure < 21 mm Hg in each eye
Exclusion criteria 4
- Allergy to atropine
- 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).
- Prior myopia control treatment (Atropine, ortho-keratology, multifocal contact lenses
- Glaucoma
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of AL in children with progressive myopia.
Secondary endpoints 3
- 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.
- To evaluate the safety, adherence, and reasons for nonresponse of atropine 0.05% compared to atropine 0.5% treatment
- To evaluate the rebound effect after treatment-stop.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Atropine 1.0% eye drops solution
PRD11041995 · Product
- Active substance
- Atropine Sulfate
- Substance synonyms
- SYN1012701, NVK002, ATROPINE SULPHATE
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OCULAR
- Max daily dose
- 2 U unit(s)
- Max total dose
- 3650 U unit(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01FA01 — ATROPINE
- Marketing authorisation
- PL 45043/0132
- MA holder
- NEON HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- diluted to 0.5% and 0.05%
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Jan Roelof Polling
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Trialbureau oogheelkunde
Locations
1 EU/EEA country · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 550 | 21 |
| Rest of world | — | 0 | — |
Investigational sites
Leids Universitair Medisch Centrum (LUMC)
Ophthalmology, Albinusdreef 2, 2333 ZA, Leiden
Oogkliniek Den Haag
Ophthalmology, Enthovenplein 1, 2521 DA
Bergman Clinics Nederland B.V.
Ophthalmology, Gooimeer 11, 1411 DE, Naarden
Flevoziekenhuis Stichting
Ophthalmology, Hospitaalweg 1, 1315 RA, Almere
Stichting OLVG
Ophthalmology, Oosterpark 9, 1091 AC, Amsterdam
Martini Ziekenhuis
Ophthalmology, van Swietenplein 1, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Ophthalmology, P. O. Box 2040, 3000 CA, Rotterdam
Haga Hospital
Ophthalmology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Maastricht University Medical Center+
Ophthalmology, P. Debyelaan 25, 6229 HX, MAASTRICHT
Oogartsenpraktijk Delfland
Ophthalmology, Ezelsveldlaan 108a, 2611 DK
Radboud universitair medisch centrum / RADBOUDUMC
Ophthalmology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Admiraal De Ruyter Ziekenhuis B.V.
Ophthalmology, 'S-Gravenpolderseweg 114, 4462 RA, Goes
Sint Antonius Ziekenhuis Stichting
Ophthalmology, Koekoekslaan 1, 3435 CM, Nieuwegein
Reinier de Graaf Groep
Ophthalmology, Reinier De Graafweg 5, 2625 AD, Delft
Ziekenhuis Rivierenland
Ophthalmology, President Kennedylaan 1, 4002 WP, Tiel
Albert Schweitzer Ziekenhuis
Ophthalmology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Frisius
Ophthalmology, Thialfweg 44, 8441 PW, Heerenveen
Oogcentrum NH
Ophthalmology, Gildestraat 10, Netherlands
Deventer Ziekenhuis
Ophthalmology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Stichting Elisabeth-Tweesteden Ziekenhuis
Ophthalmology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Oogkliniek Drechtsteden
Ophthalmology, Veerpromenade 22, Netherlands
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-08-02 | 2024-08-02 | 2026-05-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol MAD version 2_1 09 oct 2023 clean signed | 2.1 |
| Protocol (for publication) | D1_Protocol 2024-516379-34-00_version 3_0 11 Nov 2024 clean_signed | 3.0 |
| Protocol (for publication) | D1_Protocol 2024-516379-34-00_version 3_0 11 Nov 2024 tc | 3.0 TC |
| Protocol (for publication) | D1_Protocol_2024-516379-34-00 Clean | 5.0 |
| Protocol (for publication) | D1_Protocol_2024-516379-34-00 TC | 5.0 |
| Protocol (for publication) | D6_Overview of significant protocol changes | 5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements V1_0 30Jan2025 | 1 |
| Recruitment arrangements (for publication) | Replacement document regarding transition | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF children until 12 years MAD V2_0 14Nov2022 | 2.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF children-12-to-16-years_MAD V2 14NOv2022 | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF parents MAD V2_1 09-10-2023 clean | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmCP Atropinesulfaat 12-08-2021 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-516379-34-00 V1 20Nov2024 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2024-516379-34-00 V1 20NOV2024 | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Netherlands | Acceptable with conditions 2024-08-02
|
2024-08-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-09 | Netherlands | Acceptable with conditions 2024-08-02
|
2024-10-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-11 | Netherlands | Acceptable 2025-01-23
|
2025-01-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-03 | Netherlands | Acceptable 2025-03-28
|
2025-03-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-17 | Netherlands | Acceptable 2025-05-27
|
2025-05-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-07 | Netherlands | Acceptable | 2025-11-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-23 | Netherlands | Acceptable 2026-04-30
|
2026-04-30 |