Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
90
Countries
1
Sites
3
Cataract
Key facts
- Sponsor
- Ntc S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 22 Apr 2024 → 20 Mar 2025
- Decision date (initial)
- 2024-02-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cataract
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ntc S.r.l.
- Sponsor organisation
- Ntc S.r.l.
- Address
- Via Luigi Razza 3
- City
- Milan
- Postcode
- 20124
- Country
- Italy
Scientific contact point
- Organisation
- Ntc S.r.l.
- Contact name
- Dr. Alessandro Colombo
Public contact point
- Organisation
- Ntc S.r.l.
- Contact name
- Dr. Alessandro Colombo
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 90 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Clinica Oculistica, Via Antonio Di Rudini' 8, 20142, Milan
Universita' Degli Studi Di Verona
Unità Operativa Complessa di Oculistica, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliero Universitaria Pisana
Dipartimento di Patologia Chirurgica, Medica, Molecolare e dell'Area Critica, Via Paradisa 2, 56124, Pisa
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 |
|---|---|---|---|---|---|
| Italy | 2024-04-22 | 2025-03-20 | 2024-05-03 | 2024-09-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-12 | Italy | Acceptable 2024-02-09
|
2024-02-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-13 | Italy | Acceptable 2024-02-09
|
2024-06-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-30 | Italy | Acceptable 2024-02-09
|
2024-07-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-12-19 | Italy | Acceptable 2024-02-09
|
2024-12-19 |