Study of the preliminary efficacy and safety of topical cysteamine formulated in viscous solution in cystinosis patients

• Conditions: Cystinosis; MedDRA version: 16.1Level: PTClassification code 10011777Term: CystinosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-003228-35-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Last Update Posted: 31 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must meet each of the following criteria to be eligible for admission to the study:
-Cystinosis patients treated with cysteamine 0.55% eye drops (saline solution), made ??by the Pharmacy Department of Hospital Universitari Vall d'Hebron.
-Age ? 5 years
-Cooperative and compliant patient
-Parents who sign the consent or acquiescence in patients over 12 years old.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
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

-Using other eye topical treatments.
-Withdrawal of consent or acquiescence.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified