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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 23
- 试验地点
- 9
- 主要终点
- the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No participation in another trial contemporary at this one
结局指标
主要结局
the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available)
时间窗: 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).
时间窗: 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.
次要结局
未报告次要终点