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.

NCT07195864 | Recruiting

• 1 other identifier: 059/SI
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Acanthamoeba Keratitis

Keywords

Acanthamoeba Keratitis PHMB

Outcome Measures

Primary Outcomes (2)

• 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

  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.

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

Interventions

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.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Age ≥12 years at the time of diagnosis.

You may not qualify if:

• No participation in another trial contemporary at this one

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (5)

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, 46026, Spain

RECRUITING

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 Design

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

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 29, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)