NCT07400952招募中2 期
Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change from baseline in maximum corneal curvature
研究概览
简要总结
Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily topically administered GLK-221 Ophthalmic Solution in subjects with keratoconus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be ≥ 18 and ≤ 55 years of age
- •Diagnosis of keratoconus in the study eye
排除标准
- •Pregnant, lactating or planning a pregnancy
- •Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial
研究组 & 干预措施
GLK-221 Ophthalmic Solution
Experimental
GLK-221 Ophthalmic Solution administered topically twice daily to both eyes
干预措施: GLK-221 Ophthalmic Solution (Drug)
Placebo
Placebo Comparator
Placebo Ophthalmic Solution administered topically twice daily to both eyes
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Mean change from baseline in maximum corneal curvature
时间窗: 16 weeks
Mean change from baseline in maximum corneal curvature
次要结局
未报告次要终点
研究者
研究点 (1)
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