A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery, Including a Corneal Endothelial Cell Sub-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 31
- 主要终点
- Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
研究概览
简要总结
This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.
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
- •Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
- •Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit
- •Willing and able to comply with study requirements and visit schedule.
- •Provide signed and dated informed consent.
排除标准
- •Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
- •Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
- •Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit
- •Note: Other inclusion/exclusion criteria apply.
研究组 & 干预措施
APP13007 0.05% BID
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
干预措施: APP13007, 0.05% (Drug)
Matching Vehicle Placebo
1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
干预措施: Matching Vehicle Placebo for APP13007, 0.05% (Drug)
结局指标
主要结局
Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
时间窗: Postoperative Day 8 and Postoperative Day 15
The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication
时间窗: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).
Participants With Treatment-emergent Adverse Events (AEs)
时间窗: From First dose to Postoperative Day 22 (End of Main Study)
Number of participants with ocular and systemic treatment-emergent AEs.
次要结局
- Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication(Postoperative Day 15)
- Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication(Postoperative Day 15)
- Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication(Postoperative Day 8)
- Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication(Postoperative Day 4)
- Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication(Postoperative Day 15)
- Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15(Baseline and Postoperative Day 15)
- Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication(Postoperative Day 8)
- Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication(Postoperative Day 8)
- Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication(Postoperative Day 4)
- Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15(Baseline and Postoperative Day 15)
- Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15(Baseline and Postoperative Day 15)
- Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8(Baseline and Postoperative Day 8)
- Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15(Baseline and Postoperative Day 15)
- Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4(Baseline and Postoperative Day 4)
- Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment(First dose to Postoperative Day 15)