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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-003228-35-ES
Enrollment
Unknown
Registered
2013-11-12
Start date
2014-07-16
Completion date
Unknown
Last updated
2015-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystinosis MedDRA version: 16.1 Level: PT Classification code 10011777 Term: Cystinosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: cysteamine (mercaptamine) viscous solution Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Mercaptamine CAS Number: 156-57-0 Other descriptive name: MERCAPTAMINE HYDROCHLOR

Sponsors

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary end point(s): Number of corneal cystine crystals;Timepoint(s) of evaluation of this end point: 3 months;Main Objective: The main objective of the study is to assess the efficacy of 0.55% cysteamine formulated in viscous solution compared with saline solution at the same dose, in corneal crystal deposition.;Secondary Objective: -The secondary objective of the study is to assess whether the efficacy of 0.55% cysteamine formulated viscous solution administered four times a day is comparable to more frequent administration. -To evaluate the tolerance and compliance with the new formulation.—

Secondary

MeasureTime frame
Secondary end point(s): Number of corneal cystine crystals (4 times a day) Number of prescription instillations/ number of instillations performed;Timepoint(s) of evaluation of this end point: 3 months—

Countries

Spain

Contacts

Public ContactStudy coordinator

Dra. Nieves Martin

nmartin@vhebron.net+34934893166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026