Status:
RECRUITING
Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/mL Polihexanide as Part of the "Medicines in Special Situations" (Medicamentos en Situaciones Especiales) Program in Spain.
Lead Sponsor:
SIFI SpA
Conditions:
Acanthamoeba Keratitis
Eligibility:
All Genders
12+ years
Brief Summary
The study will be a multicentric, retrospective, non-interventional medical chart review of patients with AK who initiated a treatment with 0.8 mg/ml polihexanide as part of the Spanish Medicines in S...
Detailed Description
Primary objective: • To describe the efficacy of 0.8 mg/ml polihexanide in the clinical resolution of AK in all patients that satisfy the inclusion criteria of the study, as measured by the proportio...
Eligibility Criteria
Inclusion
- Participation in the Spanish Medicines in Special Situations (Gestión de Medicamentos en Situaciones Especiales) program from August 2022 to 31 October 2024, because they presented clinical signs and symptoms consistent with AK and the identification of Acanthamoeba was confirmed by at least one of the following techniques:
- o Confocal Microscopy o PCR o Identification by microbiological culture or cytological smear.
- • Diagnosis of AK at least 2 months before inclusion in the study
- • Age ≥12 years at the time of diagnosis.
- • To have started and completed the treatment with 0.8 mg/ml polihexanide at the moment of the inclusion.
Exclusion
- No participation in another trial contemporary at this one
Key Trial Info
Start Date :
October 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07195864
Start Date
October 30 2025
End Date
June 30 2026
Last Update
November 26 2025
Active Locations (4)
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1
HU Ramon y Cajal
Madrid, Principality of Asturias, Spain
2
HU La Paz
Madrid, Spain
3
IO Fernandez Vega
Madrid, Spain
4
CHUO Ourense
Ourense, Spain