A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 9
- 主要终点
- Number of Treatment Emergent Adverse Events
研究概览
简要总结
This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
- •In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
- •Have > 10 and ≤ 30 cells in anterior chamber.
- •Have an intraocular pressure ≤ 30 mmHg.
排除标准
- •Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.
- •Have a score > 0 on Ocular Pain Assessment in either eye.
研究组 & 干预措施
APP13007 0.05% twice daily (BID) [Part A]
1 drop 0.05% APP13007 twice daily for 21 days to the operated eye
干预措施: APP13007, 0.05% (Drug)
APP13007 0.05% Placebo twice daily (BID) [Part A]
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
干预措施: APP13007 Placebo, 0.05% (Drug)
APP13007 0.05% twice daily (BID) and once daily (QD) [Part B]
1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
干预措施: APP13007, 0.05% (Drug)
APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B]
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
干预措施: APP13007 Placebo, 0.05% (Drug)
APP13007 0.1% twice daily (BID) and once daily (QD) [Part B]
1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
干预措施: APP13007, 0.1% (Drug)
APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B]
1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
干预措施: APP13007 Placebo, 0.1% (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events
时间窗: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
Number of treatment emergent adverse events and number of participants.
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye
时间窗: Baseline and Post-operative Day 15
Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye
时间窗: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.
Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye
时间窗: Baseline and Post-operative 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.
Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
时间窗: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' \[ETDRS\] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters.
次要结局
- Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication(Post-operative Day 15)
- Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye(Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B))
- Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication(Post-operative Day 15)
- Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment(First dose to Post-operative Day 22 (Part A) or Day 15 (Part B))