Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 below 2 years old could be of value for these patients and prevent the crystal deposit. It is the reason why as part of the Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric population from 6 months to less than 2 years old.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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