Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/ml Polihexanide

NCT06641882 | Completed

• 1 other identifier: 057/SI
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Acanthamoeba Keratitis

Outcome Measures

Primary Outcomes (1)

• 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.

  The study period is the period from T0 to the end of treatment (Up to 52 weeks)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age \>14 years.
• Clinical signs and symptoms consistent with AK.
• Identification of Acanthamoeba (diagnostic confirmation of AK) by at least one of the allowed techniques as:
• Confocal Microscopy
• PCR,
• Identification by microbiological culture or cytological smear.
• Accept to sign the informed consent.
• Treatment with 0.8 mg/ml polihexanide.
• End of treatment with 0.8 mg/ml polihexanide.
• Medical chart available at clinical site.

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (10)

ASST Spedali Civili

Brescia, Brescia, 25121, Italy

Location

SOD Oculistica Azienda Ospedaliero Universitaria Careggi

Florence, Italy, 50134, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

Location

AZIENDA ULSS 3 Serenissima-UOC Oculistica

Venice, Italy, 6777, Italy

Location

Policlinico G.Martino

Messina, Messina, 98124, Italy

Location

ASST Fatebenefratelli Sacco

Milan, Milano, 20157, Italy

Location

Policlinico S. Matteo

Pavia, Pavia, 27100, Italy

Location

Policlinico TorVergata

Rome, Rome, 00133, Italy

Location

Policlinico Universitario Campus Biomedico

Rome, Rome, 00133, Italy

Location

Azienda Ospedaliera Universitaria Verona

Verona, Verona, 37126, Italy

Location

MeSH Terms

Conditions

Acanthamoeba Keratitis

Condition Hierarchy (Ancestors)

Eye Infections, Parasitic; Parasitic Diseases; Infections; Amebiasis; Protozoan Infections; Keratitis; Corneal Diseases; Eye Diseases; Eye Infections

Study Officials

• Karl Knutsson, MD

  San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: September 30, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-07

Locations

IT (10)