Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
111
Countries
1
Sites
1
Myopia
To determine the efficacy and safety of the combined use of diluted atropine eye drops 0.025% and DIMS technology ophthalmic lenses in the control of myopia progression in the paediatric population.
Key facts
- Sponsor
- Hospital Clinico San Carlos
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 16 Feb 2022 → ongoing
- Decision date (initial)
- 2024-07-18
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514651-15-00
- EudraCT number
- 2021-003373-64
- ClinicalTrials.gov
- NCT06431841
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To determine the efficacy and safety of the combined use of diluted atropine eye drops 0.025% and DIMS technology ophthalmic lenses in the control of myopia progression in the paediatric population.
Secondary objectives 3
- To know the tolerability of ophthalmic lenses with DIMS technology in a myopic paediatric population.
- Correlating the data obtained with patient-specific covariates
- Evaluate and measure the effect on refractive state and axial length in each group
Conditions and MedDRA coding
Myopia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients between 4-16 years old
- Informed consent signed by parents or tutors for all patients and for patients aged 12-16 years. Assent in children under 12 years old
- Refractive defect: myopia greater than -1.00 dioptres (D)
- Myopia progression of at least -0.50 D in the last 12 months
- Astigmatism of 2 D or less and anisometropia of 1.50 D or less
- Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better
Exclusion criteria 8
- Children under 4 years old and over 16 years old
- Strabismus and binocular vision anomalies
- Alterations in eye fundus that the researcher consider necessary the patient exclusion
- Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
- Amblyopia
- Previous ocular surgery
- Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline condition of the patient that does not allow the examination to be performed (such as mental or psychomotor retardation)
- Previous treatments for myopia control, including orthokeratology, rigid contact lenses, bifocal soft contact lenses or for myopia control, bifocal and multifocal ophthalmic lenses in the 3 months prior to the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Change in refractive error after cycloplegia (with 1% cyclopentolate 3 drops 10 minutes apart; measured after 30 minutes) relative to baseline values.
- Proportion of patients presenting adverse events
Secondary endpoints 3
- Change in axial length in millimetres, relative to baseline values
- Change in choroidal and retinal thickness measured on Optical Coherence Tomography (OCT) in μm, relative to baseline values
- Change in intraocular pressure in mmHg, relative to baseline values
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1145632 · ATC
- Active substance
- Atropine Sulfate
- Substance synonyms
- SYN1012701, NVK002, ATROPINE SULPHATE
- Route of administration
- OPHTHALMIC
- Max daily dose
- 1 Other
- Max total dose
- 1095 Other
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01FA01 — ATROPINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Dose 0.025 % (1 drop a day)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Clinico San Carlos
- Sponsor organisation
- Hospital Clinico San Carlos
- Address
- Calle Del Profesor Martin Lagos Sn
- City
- Madrid
- Postcode
- 28040
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Clinico San Carlos
- Contact name
- Investigator Sponsor
Public contact point
- Organisation
- Hospital Clinico San Carlos
- Contact name
- Investigator Sponsor
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 111 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2022-02-16 | 2022-02-23 | 2023-06-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_01-DIMS-2021_Transition_2024-514651-15-00_V7_05022024 | 7 |
| Recruitment arrangements (for publication) | Not applicable_Recruitment Arrangements_01-DIMS-2021 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF children and adolescents_01-DIMS-2021 | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF children and adolescents_extension_01-DIMS-2021 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents and tutors__extension_01-DIMS-2021 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents and tutors_01-DIMS-2021 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC atropine_01-DIMS-2021 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Spain | Acceptable with conditions 2024-07-18
|
2024-07-18 |