NCT06128369终止3 期
A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Ophthalmic Suspension in the Treatment of Inflammation and Pain Following Cataract Surgery
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Oculis
- 入组人数
- 117
- 试验地点
- 25
- 主要终点
- To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery
研究概览
简要总结
This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.
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
- Double (Participant, Investigator)
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
- •Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye.
- •Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]).
排除标准
- •Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit-lamp examination.
- •Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye.
结局指标
主要结局
To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery
时间窗: Visit 6 (Day 15)
Absence of anterior chamber cells (i.e. score of '0')
To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery
时间窗: Visit 4 (Day 4)
Absence of pain (i.e. score of '0')
Absence of Anterior Chamber Cells at Visit 6.
时间窗: Day 15.
Absence of Ocular Pain at Visit 4.
时间窗: Day 4.
次要结局
- Absence of Anterior Chamber Cells at Visits 4 and 5.(Days 4 and 8.)
- Absence of Ocular Pain at Visits 3, 5, and 6.(Days 2, 8, and 15.)
- Absence of Flare at Visits 4, 5, and 6.(Days 4, 8, and 15.)
- Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.(Days 4, 8, and 15.)
- Use of Rescue Medication on or Prior to Each Visit.(Days 1, 2, 4, 8, 15, and 22.)
- Use of Rescue Medication Overall.(From first dose until Day 22.)
研究者
研究点 (25)
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