Overview
Sponsor-declared trial summary
pediatric cataract
Evaluation of the efficacy and safety of the use of Mydrane in children
Key facts
- Sponsor
- Antwerp University Hospital
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 1 Jul 2023 → 17 Sep 2025
- Decision date (initial)
- 2023-06-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- none
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Evaluation of the efficacy and safety of the use of Mydrane in children
Conditions and MedDRA coding
pediatric cataract
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Children aged 8 weeks to 17 years old who are scheduled for surgical cataract repair of one or both eyes
Exclusion criteria 4
- Patients with a reported allergy for one of the components of Mydrane®
- Patients younger than 8 weeks
- patients who previously had cataract surgery of one eye within this study and receive surgery of the contralateral eye on a different day
- Patients who are pregnant. Girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Sufficient pupillary dilatation to perform surgery without mechanical dilatation
Secondary endpoints 1
- Hart rate and blood pressure
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml oplossing voor injectie
PRD3899019 · Product
- Active substance
- Phenylephrine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAOCULAR USE
- Max daily dose
- 0.2 ml millilitre(s)
- Max total dose
- 0.2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01FA56 — TROPICAMIDE, COMBINATIONS
- Marketing authorisation
- BE489680
- MA holder
- LABORATOIRES THEA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Antwerp University Hospital
- Sponsor organisation
- Antwerp University Hospital
- Address
- Drie Eikenstraat 655
- City
- Edegem
- Postcode
- 2650
- Country
- Belgium
Scientific contact point
- Organisation
- Antwerp University Hospital
- Contact name
- Luc Van Os
Public contact point
- Organisation
- Antwerp University Hospital
- Contact name
- Luc Van Os
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 40 | 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 |
|---|---|---|---|---|---|
| Belgium | 2023-07-01 | 2025-09-17 | 2023-07-01 | 2023-08-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-15 | Belgium | Acceptable with conditions 2023-06-30
|
2023-06-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-10 | Belgium | Acceptable with conditions 2023-06-30
|
2023-08-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-19 | Belgium | Acceptable 2023-11-27
|
2023-11-28 |