An observational study in Acanthamoeba Keratitis, sponsored by SIFI SpA. Completed at 10 sites in Italy. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by SIFI SpA · Observational
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This will be a non-interventional study with secondary use of data. The study will be a site-based retrospective review of medical chart of patients with AK who initiated and completed a treatment with 0.8 mg/ml polihexanide as part of a compassionate use program. Patientlevel data will be abstracted from medical chart of eligible patients at participating sites and imputed in an electronic case report form (eCRF). Baseline (Time 0) is the date of initiation of 0.8 mg/ml polihexanide. The study period is the period from T0 to the end of treatment. The clinical outcome needs to be confirmed at least 30 days after the conclusion of the treatment.
Acanthamoeba keratitis (AK) is an ultra-rare potentially devastating ocular infection that occurs primarily in contact lens wearers. The estimated incidence in Europe varies between 1 and 3 cases/million people per year. AK is caused by a ubiquitous free-living protozoan that is present in air, soil, dust, fresh water, seawater, and bottled water. The amoebic organism exists both as dormant cysts and active trophozoites. The cysts are highly resilient and can withstand a wide variety of physical conditions and drugs which makes medical treatment of AK both difficult and protracted. If left untreated, the cure rate is low with most patients needing keratoplasty and some of them requiring enucleation. There is currently no approved pharmacological treatment for AK. Available treatment options are represented by off-label antiseptic products which are either imported or compounded, the most used being biguanides (polihexanide-PHMB- or chlorhexidine), given alone or in combination with a diamidine (propamidine or hexamidine). The actual reported medical cure rate with no surgery is approximately 60%; in addition almost 50% of patients have a poor outcome, defined as a poor visual acuity and/or necessity of ocular surgery. Polihexanide 0.8 mg/ml, an eye drops solution developed and manufactured by SIFI SpA (Italy), has the potential to become the first treatment approved for the treatment of AK. Its efficacy and safety were demonstrated in the pivotal clinical study 043/SI (EUDRACT no. 2016-001823-30; ClinicalTrials.gov: NCT03274895), in which the mean (95% IC) cure rate with no surgery was 84.8% (73.9-92.5) with a median (95% IC) time-to-cure of 146 (94-217) days. In addition, no major safety issues were observed during the trial. A positive opinion from the Committee for Medicinal Products for Human Use at EMA is expected in Q2/2024. Polihexanide 0.8 mg/ml has been made available in Italy by SIFI S.p.A. through a compassionate use program (CUP) since November 2022 (Compassionate use program, version 1.1-ITA-Aug 11, 2022). As of December 2023, the treatment with 0.8 mg/ml polihexanide was approved for 71 patients with AK. SIFI prepared this protocol to conduct a retrospective medical chart review of patients which already completed the treatment with 0.8 mg/ml polihexanide as part of the CUP. The expected number of evaluable patients is 40. According to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) this will be a Non-Interventional Study (as defined in the Directive 2001/20/EC) with secondary use of data. The protocol was prepared following the good practices report of the ISPE/ISPOR task force.
The expected contribution from this study will be to expand patient's exposure to polihexanide 0.8 mg/ml and provide further information on its effectiveness and safety when used in the clinical practice compared with the findings observed in the pivotal clinical trial.
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.
Subjects included in the study will be patients who have received 0.8 mg/ml polihexanide through the CUP. Clinical sites with at least 3 patients in the CUP will be selected.
Inclusion Criteria:
Identification of Acanthamoeba (diagnostic confirmation of AK) by at least one of the allowed techniques as:
Additional inclusion criteria:
Exclusion Criteria: None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To describe the effectiveness of 0.8 mg/ml polihexanide as measured by the proportion of patients cured over time, between baseline (T0) and end of study period.
The outcome of interest will be the medical cure defined as the presence of an intact corneal epithelium, no or mild signs of ocular inflammation and no surgery.
Time frame: The study period is the period from T0 to the end of treatment (Up to 52 weeks)
Ran from Sep 2024 to primary completion in Sep 2025, 11 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Acanthamoeba Keratitis
SIFI SpA