Amblyopia MedDRA version: 9.1 Level: LLT Classification code 10001906 Term: Amblyopia
Conditions
Interventions
Product Name: CEBROLUX
Pharmaceutical Form: Granules
Other descriptive name: retinol vitamin E vitamin C vitamin B6 citicoline
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 3-12 Amblyopia Written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients affected by serious disease who are not eligible Use of trial drugs in the last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy evaluation of CYTIDIN-5 -DIPHOSFOCHOLINE on vision function in patients affected by amblyopia;Secondary Objective: Safety and efficacy in clinical practice of a food supplement;Primary end point(s): Efficacy in visual acuity as measured by ETDRS scale | — |
Countries
Italy
Outcome results
None listed