CTRI/2025/04/085722尚未招募Phase 3 4
Comparative Efficacy of Natamycin Monotherapy vs. Natamycin with Posaconazole in Mild to Moderate Fungal Keratitis: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.Number of cases achieving medical cure.
研究概览
简要总结
This study aims to assess whether the addition ofPosaconazole to Natamycin improves treatment outcomes in mild to moderatefungal keratitis. The findings will help refine treatment protocols and provideinsights into the efficacy of combination antifungal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Microbiologically confirmed fungal keratitis (smear and/or culture positive).
- •3.Corneal infiltrate size 2–6 mm, with stromal involvement not exceeding two-thirds of corneal thickness.
- •4.Vision in the other eye better than 20/
- •5.Willingness to participate in the study.
- •6.Non-pregnant individuals.
- •7.Systemically stable patients.
- •8.Willingness for admission or regular follow-up.
排除标准
- •1.Mixed infection 2.Participant not willing to participate 3.Having Advanced form of infection 4.Limbal involvement 5.Scleral involvement 6.Posterior chamber involvement.
结局指标
主要结局
1.Number of cases achieving medical cure.
时间窗: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months.
2.Incidence of corneal perforations.
时间窗: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months.
3.Number of patients requiring urgent TPK.
时间窗: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months.
次要结局
- Number of patients requiring urgent TPK.(1 week, 2 weeks, 1 month, 3 months)
研究者
研究点 (1)
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