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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: SIFI SpA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acanthamoeba Keratitis

Interventions

Type	Name	Description
DRUG	PHMB 0.08%	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.

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2025-09-29
• Last updated: 2026-03-31

Locations

5 sites across 1 country: Spain