Status:
COMPLETED
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Lead Sponsor:
RECORDATI GROUP
Conditions:
Cystinosis
Eligibility:
All Genders
6-2 years
Phase:
PHASE3
Brief Summary
Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed. However administration of Cystadrops® in patients b...
Eligibility Criteria
Inclusion
- Patient aged from 6 months to less than 2 years old
- Cystinosis diagnosed patients confirmed by the physician and with presence of corneal cystine crystal deposits assessed during ophthalmic examination
- Evidence of a signed and dated informed consent document indicating that parents/ legally acceptable representatives had been informed of all pertinent aspects of the study (if required by regulation)
- Parents/ legally acceptable representatives who are willing to comply with regular visits and ophthalmic exams
Exclusion
- Contraindications to any of the Cystadrops® components
- Participation in another ophthalmic investigational study or intent to participate during the course of the study
- Any medical condition that would, in the opinion of the Investigator, interfere with the evaluation of the study objectives
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04125927
Start Date
September 1 2020
End Date
December 23 2022
Last Update
February 5 2024
Active Locations (6)
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1
UZ Leuven
Leuven, Belgium, 3000
2
Hôpital Necker-Enfants Malades
Paris, France
3
Klinik für Pädiatrische Nieren
Hanover, Germany
4
Bambin Gesù Hospital in Palidoro
Roma, Italy, 00146