0.8 mg/mL polihexanide treatment for Acanthamoeba keratitis in Spain
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.
This review looks at medical records to see if 0.8 mg/mL polihexanide helped people in Spain aged 12 and older with confirmed Acanthamoeba keratitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | SIFI SpA Industry-sponsored |
| Locations | 5 sites (Madrid, Madrid and 4 other locations) |
| Trial ID | NCT07195864 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, retrospective, non-interventional chart review of patients who started 0.8 mg/mL polihexanide under the Spanish Medicines in Special Situations program between August 2022 and October 2024. Baseline is defined as the date polihexanide treatment began, and the study period runs from baseline to the end of treatment with follow-up data when available. The primary outcome is the proportion of patients clinically cured at the end of the study period, with confirmation at a 30-day follow-up when available; secondary outcomes include visual acuity change, ocular findings, pain reduction, need for surgery, concomitant infections, time to resolution, and relapse rates. Data will be collected from participating Spanish hospitals and limited to patients with laboratory or imaging confirmation of Acanthamoeba who started and completed the polihexanide regimen.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 or older in Spain with confirmed Acanthamoeba keratitis who started and completed 0.8 mg/mL polihexanide through the Spanish Medicines in Special Situations program between August 2022 and October 2024.
Not a fit: Patients without laboratory or imaging confirmation of Acanthamoeba, those younger than 12, those who did not complete the polihexanide course, or patients treated outside the specified Spanish program are unlikely to be included or benefit from this review.
Why it matters
Potential benefit: If results are positive, the review could provide real-world evidence that polihexanide 0.8 mg/mL is effective and help clinicians decide on treatment options for Acanthamoeba keratitis.
How similar studies have performed: Topical biguanides like PHMB/polihexanide have shown benefit in case series and clinical experience for Acanthamoeba keratitis, although randomized controlled trial data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * No participation in another trial contemporary at this one
Where this trial is running
Madrid, Madrid and 4 other locations
- HU La Paz — Madrid, Madrid, Spain (Recruiting)
- IO Fernandez Vega — Madrid, Madrid, Spain (Recruiting)
- CHUO Ourense — Ourense, Ourense, Spain (Recruiting)
- HU Ramon y Cajal — Madrid, Principality of Asturias, Spain (Recruiting)
- Hospital la Fé — Valencia, Valencia, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.