An observational study in Acanthamoeba Keratitis, sponsored by SIFI SpA. Completed at 5 sites in Spain. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by SIFI SpA · Observational
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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 Special Situations program, whether they fully completed the treatment or not.
Baseline date is defined as the date of 0.8 mg/ml polihexanide initiation. The Study Period for each patient will be considered the period from the baseline to the conclusion of the treatment.
Primary objective:
Secondary objectives:
SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population for this study is patients diagnosed with AK treated with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
o Confocal Microscopy o PCR o Identification by microbiological culture or cytological smear.
Exclusion Criteria:
The study population for this study is patients diagnosed with AK treated with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program.
the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available)
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available). The primary analysis will be performed on all patients that satisfy the inclusion criteria of the study
Time frame: The end of the study period, confirmed at the 30-day follow-up (when available).
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available).
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available). The primary analysis will be performed on all patients that satisfy the inclusion criteria of the study.
Time frame: he end of the study period, confirmed at the 30-day follow-up (when available).
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2025 to primary completion in Jun 2026, 7 months.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Acanthamoeba Keratitis
SIFI SpA