A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 35
- 主要终点
- Complete Resolution of Anterior Chamber (AC) Cells at Day 8
研究概览
简要总结
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
详细描述
This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.
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
- •Candidates for routine, uncomplicated cataract surgery
- •In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.
排除标准
- •Known hypersensitivity/contraindication to study product(s) or components.
- •History of glaucoma, intraocular pressure (IOP) >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
- •Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery.
- •In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
研究组 & 干预措施
KPI-121 1.0% Ophthalmic Suspension
dosed BID
干预措施: KPI-121 1% Ophthalmic Suspension dosed BID (Drug)
Vehicle of KPI-121 Ophthalmic Suspension
dosed BID
干预措施: Vehicle of KPI-121 Ophthalmic Suspension dosed BID (Drug)
结局指标
主要结局
Complete Resolution of Anterior Chamber (AC) Cells at Day 8
时间窗: Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Complete Resolution of Ocular Pain at Day 8
时间窗: Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe
次要结局
- Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4(Visit 1 (Baseline) and Visit 4 (Day 4))
- Complete Resolution of Anterior Chamber (AC) Flare at Day 4(Visit 4 (Day 4) maintained through Visit 6 (Day 15))
- Complete Resolution of Ocular Pain at Day 4(Visit 4 (Day 4) maintained through Visit 6 (Day 15))