CTRI/2025/05/086457尚未招募Phase 3 4
Evaluating the Effectiveness of Tobramycin 0.3 percent vs. Dual Therapy with Fortified Cefazolin and Ciprofloxacin in Bacterial Keratitis of moderate severity
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
The objective of the study is to compare the efficacy of Tobramycin topically in the management of moderately severe bacterial keratitis and compare their outcome with the combination of cefazoline and ciprofloxacin
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 bacterial keratitis smear or smear negative cases where the the fungus has been ruled out by microscopic examination.
- •2.No prior study medication use exceeding six times per day for more than 10 days.
- •3.Corneal infiltrate size 4–6 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: Follow-up visits: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months.
2.Incidence of corneal perforations.
时间窗: Follow-up visits: 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: Follow-up visits: 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 2 months, and 3 months.
次要结局
- Best spectacle-corrected visual acuity (BSCVA) at 3 months.(3 months)
研究者
研究点 (1)
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