NCT05795699已完成3 期
A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 50
- 主要终点
- Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
研究概览
简要总结
A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years old at the screening visit (Visit 1)
- •Has a diagnosis of FECD at Visit 1
- •Meets all other inclusion criteria outlined in clinical study protocol
排除标准
- •Is a female patient of childbearing potential and any of the following is true:
- •is pregnant or lactating/breastfeeding, or
- •is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
- •Has a study eye with a history of cataract surgery within 90 days of Visit 1
- •Meet any other exclusion criteria outlined in clinical study protocol
研究组 & 干预措施
K-321
Experimental
K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
干预措施: Ripasudil (Drug)
Placebo
Placebo Comparator
Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
干预措施: Placebo (Drug)
结局指标
主要结局
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
时间窗: Baseline to Week 12
次要结局
- Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks(Baseline to Week 12)
- Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks(Baseline to Week 12)
- Central corneal ECD at Week 12(Week 12)
- Time to achievement of no corneal edema during the first 12 weeks(Baseline to Week 12)
- Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks(Baseline to Week 12)
研究者
研究点 (50)
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