Completed

NCT Number: NCT07195864

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.

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HU La Paz, Madrid, Spain

About this study

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 proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available).

Secondary objectives:

To describe the efficacy of 0.8 mg/ml polihexanide in the clinical resolution of AK in full compliant patients.

To describe the efficacy of 0.8 mg/ml polihexanide in the improvement of visual acuity (VA).

To describe the efficacy of 0.8 mg/ml polihexanide in the improvement of ocular clinical findings.

To describe de efficacy of 0.8 mg/ml polihexanide in the reduction of pain.

To determine the rate of patients requiring ocular surgery.

To determine the rate of patients using topical ophthalmologic steroids or other relevant medications.

To determine the time from start of treatment until clinical resolution.

To determine the proportion of patients with concomitant fungal or bacterial corneal infections.

To describe the efficacy of 0.8 mg/ml polihexanide in preventing disease relapse.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHMB 0.08%

Drug

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.

Primary outcomes

the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available)

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 analysis will be performed on all patients that satisfy the inclusion criteria of the study
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).

Time frame: he 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.

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 29, 2025
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed